Careers with Cirtec – Medical Device Design, Manufacturing, and Finished Device Assembly

We actively seek creative candidates in the fields of sales, program management, mechanical engineering, quality engineering, electronics and software engineering, process engineering, and manufacturing engineering, including technicians, assemblers and supervisors. Our employees have the satisfaction of knowing that the work they do is helping patients live better, longer lives, and they take pride in the work they perform for one of the industry’s top medical device companies. Here at Cirtec, every employee is highly valued and crucial to our success. We place a high value on performance excellence, career development, safety, rewards and communication. Cirtec has rewarding opportunities where you can make a difference. To view all current positions and apply online, visit the Cirtec Career Center:

If you value teamwork, client focus, accountability and innovative thinking, Cirtec is the place for you! We want to be your career choice in the Medical Device Industry. Cirtec is an equal opportunity employer and does not discriminate based on race, gender, ethnicity or sexual orientation.

Opportunities in Brooklyn Park, MN

Sr. Engineer, Process Development

Summary:

The Sr. Engineer, Process Development position is primarily responsible for working in a functional project engineering group within the department, consisting of multiple engineering disciplines. Involved in the design, development, documentation and validation and of new customer products, and modification of existing products including defining requirements, timelines, and deliverables with a focus on prototypes, process development, design verification, clinical builds, training production, and preparation for process validation and manufacturing transfer of products.

Responsibilities:

  • Attends and arranges project meetings to discuss current and future design and development initiatives.
  • May serve as a primary contact with clients on projects of moderate complexity.
  • Assist with preparation of proposals and quotations for clients; interfaces needed to resolve questions in a timely manner.
  • Assist in preparation and maintaining of project plans to satisfy milestones, deadlines, budgets, and medical device quality regulations with required actions. Track and communicate project status, plans, issues, timelines, action items, and budgets.
  • Provide guidance and direction to coworkers on areas of technical expertise.
  • Troubleshoot production processes as required.
  • Evaluate and select appropriate test methods for product requirements.
  • Responsible for the following project inputs:
    • Feasibility builds, documentation, and testing
    • Equipment selection, process development and documentation
    • Device Verification samples and testing
    • Operator training
    • Process Failure Mode Effects Analysis
    • Clinical builds
    • Process Validation
  • Involvement in the full design, development, and validation requirements of projects, including:
    • Product design and specification creation, including mechanical and electrical components, assemblies, and packaging
    • Materials sourcing and device prototyping
    • Design verification and validation activities, including data for regulatory submission
    • Manufacturing transfer and support of existing product lines as applicable
  • Reliable, consistent and punctual attendance is an essential function of the job.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • A Bachelors’ degree in an engineering discipline with 5 years of relevant experience; Associates degree in an engineering discipline w/10 years of relevant experience; or equivalent.
  • Experience in an engineering/manufacturing environment with a mix of mechanical design, tool design and manufacturing process experience.
  • Willingness to travel, if required.
  • Must maintain high ethical standards.
  • Must demonstrate good organizational skills.
  • Ability to train new engineering employees on project engineering activities and Cirtec policies and procedures.
  • Must be able to read, write and speak fluent English.
  • Strong computer skills, including the MS Office suite and MS Project.
  • Must be able to fully interpret technical drawings, blueprints, specifications, illustrations, and written documents.
  • Strong analytical skills, must be able to obtain and evaluate secondary research information.
  • Ability to learn and apply new technology.
  • Moderate knowledge of engineering principles, technical writing, material properties, good tooling practices, and statistics.

WORKING ENVIRONMENT

Work is performed in an office environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Payroll Manager

Summary:

This position is responsible to perform all duties with accuracy and promptness with an emphasis on quality and courtesy. Ability to handle and maintain highly confidential information in an appropriate manner. Provide support to both internal and external customers. Perform all duties relating to labor entry and payroll processing, including payroll taxes related items, and various accounting and benefit administrative functions.

Responsibilities:

  • Prepare and process bi-weekly payroll:
    • Enter all pay-related changes.
    • Ensure pay changes and or bonuses have proper approval prior to processing.
    • Enter/update department codes in ADP for employees.
    • Enter all benefit code changes, benefit deduction amounts if needed.
    • Enter all employee badge data information for new hires.
    • Ensure consistent set up and ADP access for peer groups including administrator rights.
    • Enter commission payments and ensure proper approval obtain prior to processing.
    • Run payroll audit reports; review changes, noting who and what changes were made, for reasonableness (prepare documentation of review for Finance).
  • Run associated payroll reports as identified and requested.
  • Conduct regular audits to ensure all payroll data fields are completed properly.
  • Be point on questions from supervisors, managers, and employees on payroll-related issues and time and attendance matters (punches).
  • Train new supervisors on how to use the ADP system including time and attendance.
  • Create training materials, key communications, cheat sheets, etc.
  • Ensure new materials are posted on SharePoint and properly distributed.
  • Set up supervisors properly with access to ADP analytics.
  • Set up supervisors so that they can access information including pay for their direct reports.
  • Issue ADP passcode requests when employees are locked out.
  • Process terminations timely and issue severance pay, or final checks as needed.
  • Request ACH payments for termed employees, as needed.
  • Responsible for proper processing of employee garnishments and levies.
  • Enter and process approved Tuition Reimbursement through ADP.
  • Conduct employee verification of employment requests.
  • Be point on any tax issues involving employees.
  • Responsible for ADP Smart Compliance.
  • Oversee and maintain ADP file feeds, and project/changes requests.
  • Oversee and process regular funding for FSA, HSA, and 401k accounts.
  • Administrator for the Standard 401(k) and, compiles 401(k) funding worksheet and send to Finance for bank withdrawal confirmation on 401(k) amounts match.
  • Issue any key communications to employees involving changes to payroll processing dates, etc.
  • Communicate ADP adjustments and/or Payroll adjustments, if applicable to Finance.
  • Lead the open annual enrollment set up in ADP.
  • Assist in regular compliance audits (401k, worker’s compensation, etc.)
  • Provide support to accounting and management team members as needed.
  • Special projects, ad-hoc reporting, and other duties as needed.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • 7 or more years of payroll and benefits experience in manufacturing environment.
  • Proficient in MS office (Word, Excel, Outlook, etc.)
  • Advanced Excel experience preferred.
  • Superior organization skills.
  • Ability to effectively work under multiple priorities and deadlines.
  • High level of computer and software skills; Experience with Made 2 Manage (preferred) and ADP (required).
  • Professional verbal and written communication skills.

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

WORKING ENVIRONMENT

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual may encounter while performing the essential functions of this position.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Senior Accountant/Analyst

Summary:

Seeking an experienced and trained Senior Accountant to oversee general ledger accounting, perform month-end closing procedures, and establish more efficient accounting procedures.

Responsibilities include Payroll and Fixed Asset Accounting, reconciling various account balances, preparing, and entering journal entries, documenting general ledger balances, providing supporting documentation to independent auditors, and establishing/improving month-end close procedures.

A successful candidate combines excellent analytical skills with a thorough knowledge of accounting principles and computer skills to analyze accounts, transactions, and financial reports. The ideal candidate will also have experience collaborating with other accounting personnel and management.

Responsibilities:

  • Reconcile month-end account balances including cash, accounts receivable, inventory, prepaid expenses, fixed assets, payroll, accounts payable, accrued expenses, debt, and other assets & liabilities
  • Make appropriate accounting entries and journal entries
  • Analyze financial information and prepare ad hoc financial analysis and reports
  • Improve design of spreadsheets to improve accuracy and efficiency
  • Suggest ways to improve efficiency in accounting procedures and operations
  • Manage Capital Requisition process and compliance with spend
  • Provide supporting documentation and assistance to independent auditors
  • Assist in providing information to outside auditors and tax accountants
  • Develop and document business processes and accounting policies to maintain and strengthen internal controls
  • Ensure compliance with GAAP
  • Perform additional related duties as needed

Reporting Relationship

  • The Senior Accountant reports directly to the Corporate Controller.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Understanding of Generally Accepted Accounting Principles (GAAP)
  • BS degree in Accounting or the equivalent; CPA is a Plus
  • Big 4 / public accounting a plus
  • Thorough knowledge of basic accounting procedures
  • Familiarity with financial accounting statements
  • Experience with general ledger functions and the month-end/year-end close process
  • Hands-on experience with ERP systems / accounting software
  • Advanced MS Excel skills
  • Accuracy and attention to detail; Aptitude for numbers and quantitative skills
  • Ability to provide appropriate documentation in support of general ledger balances
  • Ability to provide supporting documentation to external auditors

Required Skills:

  • Minimum of 4 years of Accounting experience (accounting operations and/or audit)
  • Heavy reconciliation experience
  • ERP experience desired

Education:

  • Bachelor’s Degree in Accounting
APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Machinist I

Summary:

This position is primarily responsible to maintain simple set-ups on presses or CNC equipment and have a good working knowledge of the machine he/she is working on.  Must exhibit the ability to produce quality workmanship consistently.

Responsibilities:

  • Comply with all Good Manufacturing Practices (CGMP) requirements to ensure products are consistently produced and controlled according to the Quality System.
  • Accurately completes all department paperwork including job travelers, Inspection documentation, work packet information, and tooling request forms.
  • Builds quality parts using good working knowledge of blueprints.
  • Understands, embraces, and follows Cirtec Medical workmanship specifications.
  • May be required to change tool depending upon the job schedule.
  • Actively participates in improving quality programs and team meetings.
  • Uses knowledge of the functions of the machines, including tool and work offsets, to adjust them to ensure quality.
  • Regularly inspects parts according to process to ensure quality parts are being produced.
  • Properly uses all equipment and maintains a clean work area.
  • Uses inspection equipment as required.
  • Solves problems of quality and efficiency working within the team.
  • Complies with company, quality and safety standards, policies, and procedures.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • High school diploma or G.E.D. Certificate required
  • Two-year technical degree in Machine Technology or equivalent preferred
  • Experience as a CNC Machinist or CNC education required
  • Minimum 2 years of experience programming and operating CNC machine equipment preferred
  • Ability to interpret blueprints, shop drawings, sketches. or other production orders
  • Maintain routine production records
  • Knowledge of trade tools, equipment, materials, micrometer, as well as methods and techniques used in safe machining operations
  • Ability to use precision tools (i.e., calipers) to take accurate measurements
  • Strong attention to quality and detail orientation
  • Mechanical aptitude
  • Mathematical skills
  • Ability to work independently
  • Time management skills to meet schedules and time standards, to best of ability as instructed
  • Strong interpersonal skills to establish and maintain cooperative and effective working relationships
  • Basic understand of geometric dimensions and tolerancing (GD&T), GMP and GDP
  • On-going skills training
  • Strong attention to detail
  • Knowledge of ISO & FDA requirements a plus
  • Experience with LEAN manufacturing a plus
  • Ability to work in environment subject to fluctuations in heat, humidity, fumes, odors, dust, and noise
  • Ability to provide detailed information to assist sustaining engineering in determining root cause in order to identify the appropriate corrective action
  • Good written and verbal communication skills
APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Sr. Laser Technician

Summary:

This Sr. Technician, Laser position is responsible for the safe and functional operation of laser cutting and/or welding equipment within the R&D organization.  Will be responsible for developing manual or CAD programs required to weld, cut tube and flat components.  Will assist in the development of tooling and fixtures required.

Responsibilities:

  • Provide process training to production operators
  • Perform characterizations, IQ’s, OQ’s, PQ’s, and validations
  • Provide Laser samples when appropriate to support sales effort
  • Provide assistance to Engineering to develop laser quotations and manufacturing procedures
  • Develop CNC programming using a camming software to efficiently meet print requirements
  • Assist Engineering in designing tooling for production
  • Interface with Quality to develop inspection procedures to verify acceptability of components
  • Maintain and promote laser and team safety
  • Evaluate and recommend alternative manufacturing methods
  • Maintain and encourage other to maintain a clean and orderly work area
  • Research and recommend capital equipment for the yearly budget
  • Ensure laser maintenance program is 100% up to date
  • Provides leadership to the team and interrelates well with all areas of the company
  • Effectively resolves all problems that arise or seek assistance in a timely manner
  • Assists the Team Manager in developing highly skilled individuals to be high quality efficient operators
  • Performs duties in a manner to promote good department morale with the team
  • Trains team members and new employee on machines and department procedures
  • Maintains schedules of machines to best meet customer requirements based on meeting daily production
  • schedule as supplied by M2M and Production Control
  • Demonstrates responsibility for department efficiency, quality, pre-production planning, process control, corrective actions, cleanliness and safety
  • Ensures that job BOM’s are accurate and tooling is ordered on timely manner
  • Other duties as assigned

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Degree/certificate in Laser Technology or related field helpful; electrical/mechanical or electronics, Automation Technology, Automated Machinery Systems, Robotics
  • Recent laser experience
  • Experience with high tolerance cutting, welding and drilling of metals
  • Set up of laser parameters
  • Experience or a desire to learn CAD/CAM software
APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

HR Generalist

Summary:

This position is primarily responsible is to apply business and human resources knowledge to managers, supervisors and employees regarding the application of HR practices within the company. The Human Resources Generalist performs a wide variety of HR services supporting employee relations, recruiting (online or outside recruiters), benefits, performance management, various types of Leave of Absence administration.  First point of contact to provide information to employees about company policies, benefits and general support.

Responsibilities:

  • Implement and administer employee policies.
  • Provide high-quality advice and service to management on daily employee relations and performance management issues.
  • Excellent problem-solving skills are required to handle unexpected situations.
  • Assist with implementing programs to support improving the employee experience.
  • Maintain ongoing relationships with employment agencies to ensure the selection of qualified talent.
  • Excellent verbal and written communications skills.
  • Ability to work with all levels of staff.
  • Prepare offer letters, termination letters and new hire packets.
  • Schedule meetings with employees when eligible for benefit and new hire onboarding.
  • Administer Leave Program (FMLA, disability)
  • Knowledge of federal and state labor and employment laws.
  • Complies with company, quality and safety standards, policies, and procedures
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • 2-4-year degree in related field or equivalent experience.
  • Experience working with Engineering and Manufacturing organizations required.
  • Excellent presentation, communication and interpersonal skills.
  • Intermediate skill level with Microsoft Excel and Word.
  • Basic writing, reading and arithmetic skills.
  • Strong level of understanding HR related legal issues and HR principles.
  • Able to work alone on a broad variety of projects.
  • Able to exercise effective judgment, sensitivity, creativity to changing needs and situations.
  • Customer-focused attitude; high level of professionalism and discretion.
  • Minimum of 3-5 years’ experience in a multi-disciplinary human resource role with a solid familiarity recruiting, employee relations and benefits administration.
  • Degree, training or equivalent experience in computer use and software-Microsoft Word, Excel and PowerPoint.
  • Experience with HRIS systems (ADP Workforce Now implementation, administration and training a plus.

WORKING ENVIRONMENT

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Quality System Specialist

Summary:

Responsible for ensuring operational adherence and compliance to Cirtec Medical’s Quality Management System (QMS) requirements. Ensure compliant execution and coordination of system elements within the Quality Systems & Control functions team.

Responsibilities:

  • Knowledge of identification, traceability, containment, and segregation requirements for handling of NCM.
  • Knowledge of the Materials Review Board (MRB) responsibilities and process for handling of NCM.
  • Knowledge of process(es) for investigation/analysis of returned/complaint materials.
  • Coordinate activities related to NCM, Complaint, RMA, and CAPA processes.
  • Knowledge and experience conducting investigation and root cause analysis of advanced/complex issues.
  • Experience examining the data for patterns and trends and working on cross-functional teams.
  • Escalate material nonconformances to CAPA system based on trending and monitoring analysis.
  • Communicate product performance by formal presentations to management committees.
  • Maintain quality system documents related to NCMR, CAPA, and Complaint systems.
  • Consistently abides by and conforms to all established Cirtec Medical policies and procedures.
  • Completes assigned tasks while operating independently and/or with minimal supervision.
  • Responds and adapts to changing priorities with minimal disruption.
  • Act as a CAPA Owner or support CAPA activities, as necessary, driving corrections and corrective actions to successful completion.
  • Provide support to the Supplier Quality management group as needed.
  • Provide support during internal audit and external audits.
  • Ensure adherence to training requirements regarding Quality Management System elements, controls, processes and procedures.
  • Provide training, as needed, to individuals or groups on NCM Control, CAPA, etc.
  • Must be knowledgeable of, and adhere to, the Cirtec Medical Quality Management System and its requirements.
  • Must follow occupational Safety and Health requirements including Personal Protective Equipment (PPE) guidelines and rules.
  • Support Corporate Quality Management System initiatives and continuous improvement activities.
  • Ensure compliance to regulatory standards and requirements as applicable.
  • Ensure compliance of all site personnel to Corporate and site-level QMS and functional training requirements.
  • Adhere to professional workplace attire, time, attendance and leave of absence policies.
  • Complies with company, quality and safety standards, policies, and procedures.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Associates/Bachelor of Science Degree in Manufacturing, Engineering, or Technical Field, or equivalent of directly transferrable industry work experience (Engineering or Quality discipline preferred).
  • Minimum of 2-4 years of experience in a regulated manufacturing environment required.
  • Advanced Post-Secondary Education/Training/Certification coursework (Manufacturing or Engineering discipline preferred).
  • Quality certification(s) (e.g. ASQ CQT, CQI, etc.)
  • Class I, II and/or III Medical Device manufacturing experience.
  • Other regulated manufacturing industry experience (e.g. Aerospace, Automotive, Defense, Pharmaceutical, etc.)
  • Knowledge of, and experience with, GMP/ISO Standards.
  • Strong verbal and written English language communication skills.
  • Must be able to successfully meet Cirtec Medical-specific positional/functional on-the-job training requirements as provided.
  • Must demonstrate ability and/or experience in computer use and general office software – Microsoft Office (i.e. Outlook, Word, Excel, and PowerPoint).
  • “Hands-on” self-starter with ability to work both independently and as part of a team.
  • Ability to work with a wide variety of functional areas, including R&D, Manufacturing, and QA, as required accomplishing results with minimal guidance.

WORKING ENVIRONMENT

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Production Planner

Summary:

The production planner is responsible to plan and prioritize operations schedules. The position uses ERP data to create and maintain production schedules that prioritize work for the operations team.  The planner may work with purchasing and operations operators maintain on time production.

Responsibilities:

  • Coordinate workflow on assigned items or products.
  • Use MRP and system data to meet customer demand.
  • Ensure material availability for prior to releasing items to production.
  • Monitor jobs to ensure they will finish on time.
  • Address issues that may prevent on time delivery.
  • Monitor metrics such as on time delivery, lead time, and stock-outs.
  • Ensure accurate system data.
  • Recommend and implement process improvements.
  • Ensure work is performed in accordance with the site’s Quality Management System (QMS).
  • Participate in the Engineering Change Notification process
  • Collaborate with quality, purchasing, operations, and engineering as needed.
  • Prepare performance reports.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • 2+ years of experience in a manufacturing environment.
  • Demonstrated initiative and track record of improving manufacturing processes.
  • Must be able to read, write, and speak fluent English.
  • Proficient skills in MS Office Suite, Microsoft Excel skills including pivot tables and formulas.
  • Working experience with manufacturing software is preferred.
  • Previous experience using ERP systems is required
  • Excellent organizational skills and strong communication skills.
  • Experience in an ISO or FDA regulated industry is preferred.
  • Experience in a high mix manufacturing environment is a plus.
APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Technician II, Process Development

Summary:

The Technician II, Process Development is primarily responsible for providing tools and support to engineering and production while adhering to the quality and cost requirements of the company. The tools included but are not limited to written processes and procedures, equipment and fixtures, and training programs. The development of these tools must be based on sound engineering principles and be implemented in accordance with Good Manufacturing processes (GMP) and ISO standards. This position will also support other engineers and areas as needed and performs at an advanced level.

Responsibilities:

  • Identifies, executes and promotes Continuous Improvement objectives
  • Assists in defining Lean Manufacturing requirements
  • Develop processes and procedures for projects to improve quality and cost
  • Originate and maintain written technical descriptions of processes and procedures comprehensive in scope and understandable by the audience
  • Represent engineering for Material Review Board concerning material dispositions
  • Represent Engineering in cross functional teams as assigned
  • Maintain compliance to procedures and regulatory requirements
  • Understand and follow safety policies and practices, attend safety training and wear PPE as required
  • Maintains and prepares project plans to satisfy timeline requirements
  • Prepares Engineering Change Orders for processes and components
  • Performs Corrective and Preventative Action tasks
  • Other duties as assigned

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Bachelor’s Degree in related technical field
  • 3 plus years’ experience in the engineering/manufacturing environment for medical devices
  • FDA, cGMP principles and practices, (ISO 9001, ISO 13485)
  • Experience with Silicone molding is a plus
  • Familiarity with Pro-E / CREO and or SolidWorks is preferred
  • Strong computer skills associated with Microsoft software
  • Ability to interpret technical drawing, blueprints, specification and illustrations
  • Must be able to read, write and speak fluent English
  • Excellent reading, writing, communication, and organizational skills
  • Demonstrated ability for systematic problem solving, DMAIC

WORKING ENVIRONMENT

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Engineer II, Quality Design & Development

Summary:

The Engineer II, Quality Design & Development is responsible for providing support to product development teams and sustaining manufacturing/operations teams.  This individual will be expected to apply design control principles and techniques for medical devices. As a member of one or more cross-functional teams, this individual will ensure products are designed and developed in accordance with applicable regulatory requirements, customer requirements, and company policy.

Responsibilities:

  • Perform Design Quality Engineering activities throughout the design, development and production of medical devices to ensure compliance to company’s Design Control procedures and regulatory requirements (specifically FDA 21 CFR 820 and ISO 13485).
  • Demonstrated understanding and application of regulations and standards (specifically ISO 14971, 2017/745 EUMDR, IEC 60601, IEC 10993).
  • Create, review and/or approve technical Design Control documentation to facilitate design, development, and product verification testing of medical devices in collaboration with cross-functional engineering teams.
  • Create and execute Quality Plans for Product Design and Development projects.
  • Represent Quality Engineering in technical design and phase end reviews.
  • Develop and perform Design of Experiments (DOE).
  • Develop and validate test methods.
  • Develop sampling plans and acceptance criteria for product testing and inspection methods using appropriate statistical techniques.
  • Lead and/or participate in risk management activities, develop Risk Management Plans and Reports, perform Hazards Analysis and FMEAs (Failure Mode Effects Analysis) to evaluate and ensure product safety and functionality.
  • Conduct and/or support root cause investigations, develop and implement corrective and preventative actions for quality system and product related nonconformances.
  • Support quality system improvement initiatives and CAPA’s.
  • Responsible for the assessment of technical standards, labeling and technical file requirements.
  • Responsible for the assessment of component and system level specifications relative to customer needs and product performance specifications.
  • Perform requirement flow down analysis on critical to quality product performance specifications down to components and process.
  • Apply Design for Reliability and Manufacturability tools and techniques.
  • Support for multiple projects, balancing priorities and resources to meet both project and management expectations.
  • Prepare reports required by the project or department management.
  • Lead and/or participate in reviews and communications with customers.
  • Reliable, consistent and punctual attendance is an essential function of the job.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • B.S. Degree in Engineering or associated fields, or equivalent industry experience.
  • 2+ years’ experience in design, quality, or reliability engineering in medical devices.
  • Knowledge of quality assurance and regulatory compliance including Quality System Standards and Regulations.
  • Knowledge of product development processes and methods.
  • Knowledge of systems engineering discipline, Technical Standards, Hazard Analysis and Failure Mode and Effects Analysis (FMEA), Qualification, Test Method and Process Validation.
  • Knowledge in the application of risk management.
  • ASQ Certification preferred.

WORKING ENVIRONMENT

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Production Supervisor (2nd Shift)

Summary:

This is a 2nd shift supervisor.

This position is primarily responsible to direct the development and implementation of activities in production area(s) to meet production goals, quality, and cost objectives. Plan, organize and schedule production activities to meet customer demands. Provide direction, leadership, and motivation to production personnel, including training and assistance with adhering to the quality system.

Responsibilities:

  • Provide leadership and direction across the associated shift ensuring proper levels of production and quality are met.
  • Responsible for ensuring conformance to all company policies, procedures, and work instructions.
  • Plan, organize, and schedule production activities (including personnel and equipment) to meet schedules for both standard production and development projects.
  • Coordinate hiring and training of new employees along with recording the status of the training.
  • Coordinate job rotations and cross training.
  • Prepare and submit performance reports along with determining what increases employees will receive based on performance.
  • Regularly communicate team performance to employees and management.
  • Preemptively coordinate material and system requirements to ensure minimum amount of downtime and recommend measures to improve production methods, yields, and the quality of product.
  • Maintain production goals and deadlines. Preemptively coordinate material and system requirements to ensure minimum amount of downtime and recommend measures to improve production methods, yields, and the quality of product.
  • Manage production personnel, including planning personnel needs, participating in the hiring process, and managing performance.
  • Conduct daily team meetings for proper communication and development of production team.
  • Develop in depth knowledge of production processes and associated equipment, including laser workstations and CNC motion control programs. Troubleshoot manufacturing issues as part of maintaining production schedule and developing self-reliance among production technicians.
  • Contribute to development, maintenance, and follow up of production metrics.
  • Plan, implement, and maintain the production environment with focus on safety, cleanliness, and organization.
  • Participate on and lead teams that improve safety, quality, and reliability in the production area, as well as teams that support cost saving and team building initiatives (QDC).
  • Plan and implement technical skills training for production personnel, including generic and product specific skills. Act as trainer when necessary.
  • Understand the requirements of and ensure compliance with the preventative maintenance program.
  • Complies with company, quality and safety standards, policies, and procedures.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Be able to read, write and speak fluent English.
  • Associates degree or equivalent experience in a related field.
  • Minimum 3+ year’s supervisory experience in a manufacturing environment, preferably in a medical device manufacturing environment and in leadership role.
  • Computer literate (MS Office Suite, Syteline).
  • Understanding and implementation of Lean Manufacturing and Six Sigma for process improvement and problem solving.
  • Strong knowledge of ERP/MRP business functions.
  • Able to prioritize and manage multiple responsibilities.
  • Must be able to read blueprints and interpret technical specifications and illustrations.
  • Experience in technical report writing and verbal communication skills.

WORKING ENVIRONMENT

Work is performed in an office environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters  while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Master Planner

Summary:

The Master Planner is responsible for the creation, maintenance, and improvement of operational schedules and rough-cut-capacity-planning models. The position analyzes ERP data, customer forecasts and business plans to create plans which meet customer needs efficiently. The Master Planner works across functions to ensure product information, production capabilities and supply routes are accounted for in plans. The Master Planner may provide work direction to other members of the Supply Chain and Manufacturing departments.

Responsibilities:

  • Plan and prioritize operations to ensure orders are manufactured and delivered on time.
  • Establish MRP requirements, forecasting, inventory, and scheduling parameters to meet customer demand and optimize production efficiency.
  • Create and maintain rough-cut-capacity-plans and models to drive business plans.
  • Work with customer service, engineering, and operations teams to align lead times and production plans.
  • Collaborate with engineering, purchasing, and operations to create production ramp plans.
  • Continuously improve planning processes by leveraging supply chain best practices and master data management.
  • Contribute to SIOP and mange development of supply plans for assigned value streams.
  • Be an active contributor to the Engineering Change Order process. Analyze and execute tasks within Engineering Changes Orders.
  • Ensure work is performed in accordance with the site’s Quality Management System (QMS).
  • Collaborate with quality and materials team.
  • Prepare performance reports.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Bachelor’s degree and 5+ years of experience or 8+ years of relevant experience such as production planning, purchasing, materials management, or manufacturing planning.
  • Must be able to read, write, and speak fluent English.
  • Working experience ERP business functions, demonstrated use of analyzing ERP data to make decisions.
  • Proficient skills in MS Office Suite, Microsoft Excel skills including pivot tables and formulas.
  • Excellent organizational skills and strong communication skills.
  • CPM/APICS qualifications preferred.
  • Experience in an ISO or FDA regulated industry is preferred.
  • Experience in a high mix manufacturing environment is a plus.

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: None

WORKING ENVIRONMENT

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those individual encounters while performing the essential functions of this position.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Software Engineer (iOS, Swift, Xcode)

Summary:

Due to our growth, we are seeking a Software Engineer for the external devices used to control our Class II and III implantable medical devices. Based out of our headquarters in Brooklyn Park, MN, Cirtec Medical is a vertically integrated, full-service, outsource partner, bringing more than three decades of expertise to every phase of the product development lifecycle for complex medical devices, including state-of-the-art product design, development, and manufacturing. We partner with our customers to bring medical devices to market quickly, predictably, and cost-effectively.

Responsibilities:

  • Develop software designs for various external devices associated with active implantable medical devices.
  • Develop software requirements and create software design control documents.
  • Perform software design risk management activities according to applicable standards in the medical device field.
  • Unit, integration, and system testing of developed software including static and dynamic testing.
  • Participate in design reviews and in software process development activities.
  • Create and maintain project plans and Design History Files (DHF) for each project.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • BS in Electrical Engineering, Computer Engineering, Software Engineering or in an equivalent engineering discipline.
  • 2 years of experience in software development.
  • 1 year of experience programming in Swift and/or Objective C in the XCode IDE.
  • Demonstrated experience working with Human Interface Devices (HIDs).
  • Excellent oral, written, and presentation communication skills.

Preferred Qualifications

  • Database development (SQLite or equivalent).
  • Authentication Server Development knowledge.
  • Online Database development experience.
  • Familiar with IEC 62304.
  • Exposure to Model-based Systems Engineering (MBSE), SysML, UML.
  • Medical device development.

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: None

WORKING ENVIRONMENT

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Sr. Systems Engineer

Summary:

Based out of our headquarters in Brooklyn Park, MN, the Systems Engineer will be responsible for system-level development and implementation of electronic and software designs for Class II and III medical devices.  The Systems Engineer will work with a multi-disciplinary engineering team including software, electrical and mechanical hardware engineers and all other functions of the company to ensure high quality and on-time product introductions. This team player will have experience with multi-tasking in a high energy fast paced environment. Must be enthusiastic, positive, even tempered and have strong skills in areas of dependability, interpersonal relationships, and communication.

Responsibilities:

  • Create requirements, engineering specifications, and test protocols during product development.
  • Applies medical development standards, such as IEC 60601-1, 62304, 60601-1-2, ISO 14708-1, 14708-3, ISO 13485.
  • Ensure that all hardware and software requirements and specifications are being met, and that all elements are being developed to maximize performance, reliability and serviceability within the constraints of the project schedule and budget.
  • Perform detailed design analysis and conduct regular design reviews with hardware and software engineering teams.
  • Collaborate with program managers to create and manage development plans and project plans related to electronic and software systems development.
  • Lead and contribute in creation of risk management documentation, including Failure Mode Effects Analysis.
  • Develop and maintain documentation (e.g. specifications, designs, test plans and reports, etc.) required for medical product Design History Files. Manage and assist in creation of ­manufacturing process instructions, bills of material, quality inspection, and related documentation.
  • Knowledge of Quality Management System principles and methodology.
  • Participate in product development meetings and software/hardware design and risk analysis reviews.
  • Specify and assemble hardware for tests.
  • Maintain design history file and participate in periodic phase reviews.
  • Provide inputs to the team in order to improve the medical device design and test outcomes.
  • Use a thorough, systematic, open approach to problem-solving.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • BS in Electrical Engineering, Computer Engineering, Systems Engineering or in an equivalent engineering discipline.
  • Minimum of 3 years of experience in a regulated development environment.
  • Experienced with Quality Control principles and methodology.
  • Good Communication and interpersonal skills.
  • Analytical reasoning and problem solving.
  • Experience in developing requirements, engineering specifications, procedures.
  • Team player and goal oriented.
  • Knowledge of Agile development methodologies (Scrum, Kanban).
  • Excellent oral, written, and presentation communication skills.

Preferred Qualifications:

  • Engineering experience with active and passive implantable devices and peripherals for Class III medical devices.
  • SysML, UML and MBSE.
  • INCOSE ASEP or CSEP.
  • JAMA Product Development Documentation Management.
  • Experienced in electronics: analog, power and digital, oscilloscopes, general electronic test equipment.
APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Quality Lead

Summary:

This position is primary responsible for overseeing the production quality. Material Nonconformance, Leading MRB, Managing Quality Library, response to production quality concern.

Responsibilities:

  • Support production with product quality concern, identify the features in the scrap code, make decisions about acceptable/unacceptable, and record notes for MRB.
  • Create raw material nonconformance report, work-in-progress material nonconformance report. Collect nonconforming material label information, quantity, lot number etc.
  • Coordinate return material to supplier via RA, record the supplier nonconforming material in IMSxpress Supplier Monitoring module.
  • Manage Material Review Board meeting weekly, collect questionable finished products or WIP.
  • Work order review and approve for receiving material inspection report, manufactured goods, finished goods. Toggle material into M2M inventory for production use and outgoing shipment.
  • Assist quality inspection for receiving inspection and extrusion/braiding inspection when needed.
  • Enhance Quality Library for acceptable vs. unacceptable featured products with clear criteria instructed by QE. Support Inspection Plan update for pictures.
  • Assist QE to build In-Process inspection program, process development projects, process validation for continuous improvement initiatives.
  • An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • High school diploma required; bachelor preferred.
  • 1-3 years’ experience in medical device manufacturing environment.
  • Knowledge of ISO 13485 requirements a plus.
  • Experience with Quality Management System software IMSxpress or similar desired.
  • Strong communication skills, verbal and written.
  • Must be detail oriented.
APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Sr. Operator Assembler

Summary:

This position is primarily responsible for assembling product, associated systems, and basic operating of laser used in the manufacturing of products sold to our customers. This position is expected to work with and assist in the training of lower-level operators to effectively meet or exceed expectations for product quality and production rates. It is also expected that in this position there will continue to build their skills with Technicians along with taking tasks and direction from the Engineering departments. In this position you must be proficient in setting up and operating workstations perform visual and dimensional inspections needed to manufacture the products at Cirtec.

Responsibilities:

  • Comply with all Good Manufacturing Practices (CGMP) requirements to ensure products are consistently produced and controlled according to the Quality System.
  • Has the responsibility of following established documentation for product manufacturing.
  • Maintains cleanliness of work areas, machines, tools, and equipment.
  • Takes direction within the manufacturing cell from Team Lead/Supervisor.
  • Will be proficient in the task of loading components into product specific tools.
  • Primary function, processing, and product fabrication.
  • Performs in-process visual inspections with and without the use of microscopes in accordance with the requirements stated in the Process Control Document or as otherwise stated on drawings or work instructions.
  • Operates a variety of wafer fab equipment in a production environment.
  • Able to manually manipulate fragile wafers on a regular basis.
  • Works with small devices to load fixtures and process equipment.
  • Makes basic measurements and math calculations relative to tolerances, dimensions.
  • As instructed, adjusts machines to achieve conformance with specifications and maximum yield.
  • Performs pre/post-weld operations such as assembly and part cleaning.
  • Performs workstation set-ups on qualified operations.
  • Performs complex workstation set up and troubleshooting tasks.
  • Performs various dimensional inspection using specific gauges, dimensional inspection systems, verniers and micrometers.
  • Has the standard skills of operating manufacturing workstations including most laser systems used in the manufacture of products sold to our customers.
  • Proficient in the operation of computerized motion controllers.
  • Knowledge of welding operations.
  • Ability to perform workstation set up requirements for any type of processing job using existing tooling and established parameters.
  • Working knowledge of drawings, ability to interpret nomenclature and dimensions.
  • Provides direction within the manufacturing cell to associates assigned to assist them.
  • Assists Quality Control with inspection duties as required.
  • Possesses the ability to accurately follow operating manuals, maintenance instructions, Standard operating procedures & work instructions.
  • Operate effectively and maintain professionalism in an environment of deadlines and high workloads and adjust schedule or work hours to meet changes in priorities.
  • Performs additional duties as required under the direction of the Production Team Leader/Supervisor.
  • Responsible for recognizing quality issues and communicating issues to the Quality and/ or Production Supervision.
  • Acts as a resource during audits or customer visits for questions and answers or practical demonstrations.
  • When assisting upper-level Technician or Engineer accurately document development activities in a lab notebook.
  • Ability to provide input to Engineering and upper-level Technicians in regard to tool design and/or troubleshooting processes.
  • Assists in ensuring the accuracy of Process Control Documents, Parameter Sheets, Work Instructions, and Standard Operating Procedures.
  • Complies with company, quality and safety standards, policies, and procedures.
  • Reliable, consistent, and punctual attendance is an essential function of the job.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • High school diploma or General Education Degree (GED) is required
  • 4-6 years’ experience in medical device industry or equivalent training preferred.
  • Be able to read, write and speak fluent English. Must be able to frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.
  • Strong attention to detail
  • Knowledge of ISO & FDA requirements a plus.
  • Experience with LEAN manufacturing a plus.
  • Ability to work in environment subject to fluctuations in heat, humidity, fumes, odors, dust, and noise.
  • Ability to provide detailed information to assist sustaining engineering in determining root cause in order to identify the appropriate corrective action.
  • Strong interpersonal skills to establish and maintain cooperative and effective working relationships.
  • Good written and verbal communication skills.
  • Meets all requirements of Operator/Assembler Il
  • Knowledge of how to set up and operate workstations.
  • Moderate computer skills, including the MS Office suite.
  • Must be able to interpret technical drawings, blueprints, specifications & illustrations.
  • Strong analytical skills and must have the ability to obtain secondary research information from the Internet or alternate sources.
  • Ability to learn and apply new technology.
  • Technical report preparation
  • Ability to provide information to engineers for determining root cause in order to identify the appropriate corrective actions.
  • Knowledge of performing visual and dimensional inspections.

WORKING ENVIRONMENT

Work is performed in a manufacturing environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Operator Assembler II

Summary:

This position is primarily responsible for operating workstations and associated systems used in the manufacturing of products sold to our customers. This position is expected to work with lower-level Operators along with higher level Technicians to effectively meet or exceed expectations for product quality and production rates. In this position they must have a basic knowledge of how to set up and operate workstations, perform visual and dimensional inspections needed to manufacture the products at Cirtec.

Responsibilities:

  • Comply with all Good Manufacturing Practices (CGMP) requirements to ensure products are consistently produced and controlled according to the Quality System.
  • Has the responsibility of following established documentation for product manufacturing.
  • Maintains cleanliness of work areas, machines, tools, and equipment.
  • Takes direction within the manufacturing cell from upper-level operators assigned to that cell.
  • Will be proficient in the task of loading components into product specific tools.
  • Primary function, processing, and product fabrication.
  • Performs in-process visual inspections with and without the use of microscopes in accordance with the requirements stated in the Process Control Document or as otherwise stated on drawings or work instructions.
  • Performs pre/post-weld operations such as assembly and part cleaning.
  • Performs workstation set-ups on qualified operations.
  • Performs basic workstation set up and troubleshooting tasks.
  • Performs various dimensional inspection using specific gauges, dimensional inspection systems, verniers and micrometers.
  • May perform weld operations.
  • Operates a variety of wafer fab equipment in a production environment.
  • Able to manually manipulate fragile wafers on a regular basis.
  • Works with small devices to load fixtures and process equipment.
  • Makes basic measurements and math calculations relative to tolerances, dimensions.
  • As instructed, adjusts machines to achieve conformance with specifications and maximum yield.
  • Working knowledge of drawings, ability to interpret nomenclature and dimensions.
  • Provides direction within the manufacturing cell to associates assigned to assist them.
  • Assists Quality Control with inspection duties as required.
  • Recognizes quality issues and communicates these issues to Quality and/or Supervisor.
  • Must accurately document all work performed on inspection reports and customer travelers.
  • Assists in packaging of finished goods as needed.
  • Reliable, consistent, and punctual attendance is an essential function of the job.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • High school diploma or General Education Degree (GED) is required
  • 3-5 years’ experience in medical device industry, preferred but not required.
  • Be able to read, write and speak fluent English.
  • Must be able to frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.
  • Strong attention to detail
  • Meets all requirements of Operator/Assembler I
  • Knowledge of how to set up and operate workstations.
  • Ability to provide information to engineers for determining root cause in order to identify the appropriate corrective actions.
  • Knowledge of performing visual and dimensional inspections.
  • Strong interpersonal skills to establish and maintain cooperative and effective working relationships.

WORKING ENVIRONMENT

Work is performed in a manufacturing environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Operator Assembler I

Summary:

This position is primarily responsible for assembling a range of components into finished goods across one or more production lines ensuring standard documentation, quality, and production rates are met. Works under the direction of the Production Team Leader/Supervisor.

Responsibilities:

  • Complies with company, quality and safety standards, policies, and procedures.
  • Comply with all Good Manufacturing Practices (CGMP) requirements to ensure products are consistently produced and controlled according to the Quality System.
  • Has the responsibility of following established documentation for product manufacturing.
  • Maintains cleanliness of work areas, machines, tools, and equipment.
  • Takes direction within the manufacturing cell from upper-level operators assigned to that cell.
  • Will be proficient in the task of loading components into product specific tools.
  • Primary function of assisting production operators and technicians engaged in processing and product fabrication.
  • Operates a variety of wafer fab equipment in a production environment.
  • Able to manually manipulate fragile wafers on a regular basis.
  • Works with small devices to load fixtures and process equipment.
  • Makes basic measurements and math calculations relative to tolerances, dimensions.
  • As instructed, adjusts machines to achieve conformance with specifications and maximum yield.
  • Performs in-process visual inspections with and without the use of microscopes in accordance with the requirements stated in the Process Control Document or as otherwise stated on drawings or work instructions.
  • Performs pre/post-weld operations such as assembly and part cleaning.
  • Performs workstation set-ups on qualified operations.
  • May perform weld operations.
  • Must accurately document all work performed on inspection reports and customer travelers.
  • Assists in packaging of finished goods as needed.
  • Reliable, consistent, and punctual attendance is an essential function of the job.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • High school diploma or General Education Degree (GED) is required.
  • 1yr. experience in a manufacturing environment preferred but not required.
  • Must be able to read, write and speak fluent English.
  • Must be able to frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.
  • Strong attention to detail.
  • Knowledge of ISO & FDA requirements a plus.
  • Experience with LEAN manufacturing a plus.
  • Ability to work in environment subject to fluctuations in heat, humidity, fumes, odors, dust, and noise.
  • Ability to provide detailed information to assist sustaining engineering in determining root cause in order to identify the appropriate corrective action.
  • Good interpersonal skills to establish and maintain cooperative and effective working relationships.
  • Good written and verbal communication skills.

WORKING ENVIRONMENT

Work is performed in a manufacturing environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Quality Inspector I (Second Shift)

Summary:

2nd Shift: Monday – Thursday 3:00pm-1:30am 

This position is primarily responsible for performing receiving, first piece, in-process and final inspection or test on a wide variety of parts and document results. Indicate inspection status, maintain product traceability and non-conforming material control. Participate in internal audits, statistical process control and assist control of process documentation, records and equipment calibration.

Responsibilities:

  • Inspect, measure and/or test incoming parts, production first piece, in-process and final product, record results and notify appropriate personnel.
  • Indicate inspection status of parts with assigned labels and stamps.
  • Maintain product identification and traceability.
  • Control non-conforming product in accordance with documented procedures and verify timely corrective and preventative action.
  • Protect product during handling and storage in the performance of work.
  • Monitor factory environmental conditions, record data and alert adverse conditions.
  • Assist with distribution and control of process documentation and quality records.
  • Assist with control of measuring and test equipment calibration.
  • Participate in internal quality audits to verify compliance with documented procedures and specifications, record results and verify audit corrective action.
  • Assist with statistical methods of verifying and controlling process capability.
  • Provide input when required to quality planning for specific projects and products.
  • Provide leadership to production personnel on quality issues.
  • Comply with and reinforce the requirements of the Cirtec Quality System Manual and Standard Operating Procedures, ISO 9002, FDA Quality System Regulations and other customer standards.
  • Follow Occupational Safety and Health regulations, including laser safety practices.
  • Other agreed duties within the Quality Department consistent with training, qualification and experience.
  • Provide Quality Support for the disposition of discrepant material.
  • Provide leadership to production personnel in relation to quality.
  • Provide Quality Control support to Manufacturing & Engineering.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Be able to read, write and speak fluent English.
  • High school diploma.
  • 3-5 years’ minimum experience in manufacturing, preferably medical devices, with increasing responsibility or a minimum of 5 years’ experience in a manufacturing environment.
  • Certificate/s of training related to this field of work (medical or quality assurance.
  • 3 years’ experience as a Quality Control Inspector.
  • Proven experience in inspection and documenting results.
  • Able to demonstrate competence in interpreting technical drawings & specifications.
  • Proficient in the use of microscopes, measuring and test equipment.
  • Able to check dimensions, squareness, hole locations, surface relationships, finish material defects and mechanical strength of product following appropriate training.
  • Have experience in the use of PC’s and Microsoft Office software applications.

PHYSICAL DEMANDS 

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is occasionally required to stand, and/or walk. The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

WORKING ENVIRONMENT 

Work is performed in a manufacturing environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Sr. Operator Assembler

Summary:

2nd Shift: Monday-Thursday 3:45pm-1:45am

Weekend Shift: Friday-Sunday 6:00am-6:00pm

This position is primarily responsible for assembling product, associated systems, and basic operating of laser used in the manufacturing of products sold to our customers.  This position is expected to work with and assist in the training of lower-level operators to effectively meet or exceed expectations for product quality and production rates. It is also expected that in this position there will continue to build their skills with Technicians along with taking tasks and direction from the Engineering departments. In this position you must be proficient in setting up and operating workstations perform visual and dimensional inspections needed to manufacture the products at Cirtec.

Responsibilities:

  • Comply with all Good Manufacturing Practices (CGMP) requirements to ensure products are consistently produced and controlled according to the Quality System.
  • Has the responsibility of following established documentation for product manufacturing.
  • Maintains cleanliness of work areas, machines, tools, and equipment.
  • Takes direction within the manufacturing cell from Team Lead/Supervisor.
  • Will be proficient in the task of loading components into product specific tools.
  • Primary function, processing, and product fabrication.
  • Performs in-process visual inspections with and without the use of microscopes in accordance with the requirements stated in the Process Control Document or as otherwise stated on drawings or work instructions.
  • Operates a variety of wafer fab equipment in a production environment.
  • Able to manually manipulate fragile wafers on a regular basis.
  • Works with small devices to load fixtures and process equipment.
  • Makes basic measurements and math calculations relative to tolerances, dimensions.
  • As instructed, adjusts machines to achieve conformance with specifications and maximum yield.
  • Performs pre/post-weld operations such as assembly and part cleaning.
  • Performs workstation set-ups on qualified operations.
  • Performs complex workstation set up and troubleshooting tasks.
  • Performs various dimensional inspection using specific gauges, dimensional inspection systems, verniers and micrometers.
  • Has the standard skills of operating manufacturing workstations including most laser systems used in the manufacture of products sold to our customers.
  • Proficient in the operation of computerized motion controllers.
  • Knowledge of welding operations.
  • Ability to perform workstation set up requirements for any type of processing job using existing tooling and established parameters.
  • Working knowledge of drawings, ability to interpret nomenclature and dimensions.
  • Provides direction within the manufacturing cell to associates assigned to assist them.
  • Assists Quality Control with inspection duties as required.
  • Possesses the ability to accurately follow operating manuals, maintenance instructions, Standard operating procedures & work instructions.
  • Operate effectively and maintain professionalism in an environment of deadlines and high workloads and adjust schedule or work hours to meet changes in priorities.
  • Performs additional duties as required under the direction of the Production Team Leader/Supervisor.
  • Responsible for recognizing quality issues and communicating issues to the Quality and/ or Production Supervision.
  • Acts as a resource during audits or customer visits for questions and answers or practical demonstrations.
  • When assisting upper-level Technician or Engineer accurately document development activities in a lab notebook.
  • Ability to provide input to Engineering and upper-level Technicians in regard to tool design and/or troubleshooting processes.
  • Assists in ensuring the accuracy of Process Control Documents, Parameter Sheets, Work Instructions, and Standard Operating Procedures.
  • Complies with company, quality and safety standards, policies, and procedures.
  • Reliable, consistent, and punctual attendance is an essential function of the job.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • High school diploma or General Education Degree (GED) is required.
  • 4-6 years’ experience in medical device industry or equivalent training preferred.
  • Be able to read, write and speak fluent English. Must be able to frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.
  • Strong attention to detail.
  • Knowledge of ISO & FDA requirements a plus.
  • Experience with LEAN manufacturing a plus.
  • Ability to work in environment subject to fluctuations in heat, humidity, fumes, odors, dust, and noise.
  • Ability to provide detailed information to assist sustaining engineering in determining root cause in order to identify the appropriate corrective action.
  • Strong interpersonal skills to establish and maintain cooperative and effective working relationships.
  • Good written and verbal communication skills.
  • Meets all requirements of Operator/Assembler Il.
  • Knowledge of how to set up and operate workstations.
  • Moderate computer skills, including the MS Office suite.
  • Must be able to interpret technical drawings, blueprints, specifications & illustrations.
  • Strong analytical skills and must have the ability to obtain secondary research information from the Internet or alternate sources.
  • Ability to learn and apply new technology.
  • Technical report preparation.
  • Ability to provide information to engineers for determining root cause in order to identify the appropriate corrective actions.
  • Knowledge of performing visual and dimensional inspections.

WORKING ENVIRONMENT

Work is performed in a manufacturing environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Manufacturing Engineering Technician

Summary:

This position is primarily responsible for providing tools and support to production while adhering to the quality and cost requirements of the company. The tools included but are not limited to written processes and procedures, equipment and fixtures, and training programs. The development of these tools must be based on sound engineering principles and be implemented in accordance with Good Manufacturing processes (GMP) and ISO standards. This position will also support engineers as needed.

Responsibilities:

  • Identifies, executes and promotes Continuous Improvement objectives
  • Assists in defining Lean Manufacturing requirements
  • Develop processes and procedures for projects to improve quality and cost
  • Originate and maintain written technical descriptions of processes and procedures comprehensive in scope and understandable by the audience
  • Responsible for overseeing new production line implementations
  • Maintain compliance to procedures and regulatory requirements
  • Understand and follow safety policies and practices, attend safety training and wear PPE as required
  • Train team leads with new processes
  • Prepares Engineering Change Orders for processes and components
  • Performs Corrective and Preventative Action tasks
  • Complies with company, quality and safety standards, policies, and procedures
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • FDA, cGMP principles and practices, (ISO 9001, ISO 13485)
  • 3 Plus years’ experience in the engineering/manufacturing environment for medical devices
  • Ability to learn and comprehend the ESN process
  • Experience with Silicone molding is a plus
  • Strong computer skills associated with Microsoft software
  • Ability to interpret technical drawing, blueprints, specification and illustrations
  • Must be able to read, write and speak fluent English
  • Excellent reading, writing, communication, and organizational skills
  • Demonstrated ability for systematic problem solving, DMAIC

WORKING ENVIRONMENT

Work is performed in an office environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Team Lead

Summary:

This position is primarily responsible to motivate the team to meet production, quality goals, and objectives.  Provide complete, timely, and informative communication to all shifts.   Ensure that Production Control schedule is followed and contribute to all teams achieving monthly production schedules and quality goals.

  • First Shift Monday-Thursday 5:00am-3:30pm
  • Second Shift Monday-Thursday 3:45pm-2:15am

Responsibilities:

  • Assesses risks and seeks appropriate assistance from Production Manager/Supervisor.
  • Ensures safety guidelines are understood and followed at all times.
  • Resolves production problems and documents issues for discussion in meetings with Management, Engineering and Quality.
  • Recommends operational changes to Production Manager/Supervisor.
  • Gives and receives employee feedback.
  • Identifies training and cross-training needs and ensures completion of training records for work cell.
  • Facilitates team participation.
  • Review schedule with supervisor and work towards meeting shipment dates-while ensuring quality standards are being maintained.
  • Ensures material transactions are documented and communicated to Production & Inventory Control as needed to support accurate inventory counts.
  • Shop cleanliness and tidiness: Work cell is responsible for cleaning the area on a daily basis in accordance with established procedures.
  • Will have authority to shut down production for out of control situations, contact necessary personnel to solve problems, request additional resources and move resources to other areas for temporary assignments.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Be able to read, write and speak fluent English.
  • High school diploma or GED.
  • Minimum 5 years’ experience in a progressive manufacturing environment.
  • Prior experience in a Contract Manufacturing Operation (CMO) is preferred.
  • Relevant experience in leading team performance and regulatory compliance.

WORKING ENVIRONMENT

Work is performed in a manufacturing environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Quality Technician

Summary:

This position is primarily responsible is assist, support, and maintain all aspects of Cirtec Equipment (calibration and preventative maintenance), Cleanroom (cleaning and testing), and Internal Audit programs.

Responsibilities:

  • Maintain, support and continuously improve the calibration and preventative maintenance database for example; a) assisting with calibration work orders, calibration certificates, and calibration files, b) assisting and supporting coordination of on-site and off-site calibration and repair activities, c) serve as a contact for customers, vendors and equipment service personnel.
  • Assist in maintaining and supporting the Equipment/Environment out-of-specification reports and access database.
  • Perform calibration audits and in-process calibration audits to ensure compliance.
  • Performance of ESDRA and ION calibration.
  • Order and monitor replacement/spare calibration equipment as required.
  • Assist and support the Equipment Inventory and Tasks Form process.
  • Has the primary function related to maintaining the cleanroom environment thru vendor POR’s, test requests, cleaning, testing, human controls, and trending to maintain a certified ISO Class 7 cleanroom status.
  • Perform cleanroom orientation training and re-training for Cirtec personnel as needed.
  • Maintain cleanliness and organization of the gowning room, prep room, pass-thrus, and cleaning station near QC through daily cleaning task per procedures.
  • Maintain the buycards for re-ordering thru purchasing.  This also includes the Nanoclean cleaning supplies.
  • Maintain the weekly rotation of cleanroom frocks & overalls from dock to gowning room and back again.
  • Assist with vendors and customers as needed, escorting personnel, and staging & cleaning items for cleanroom entry.
  • Accurately record daily temperature, relative humidity, and room pressure differentials.  Perform simple calculations for documenting results and monitoring logs.
  • Perform & record particle counts weekly and as needed.
  • Performs in-process visual inspections of human behavior in the cleanroom in accordance with the requirements stated in Cirtec’s Quality Control System and corrects poor behavior immediately.
  • Is responsible for monthly monitoring of expiration dates and replacing expired IPA spray bottles in both the cleanroom and production areas.
  • Assist in packaging qualification testing as needed.  This includes tensile testing, burst testing, and bubble leak testing.
  • Complies with company, quality and safety standards, policies, and procedures.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • High school diploma.
  • 1-3 years’ experience in manufacturing environment (preferred requirement- medical industry).
  • Technical training and/or experience in a related field.
  • Must be able to read, write and speak fluent English.
  • Knowledge of ISO 13485 requirements.
  • Experience in use of computer systems specifically Microsoft Office, calibration and maintenance programs.
  • Strong verbal and written communication skills.
  • Ability to work with a wide variety of functional areas, including but not limited to Program Management, R&D, Manufacturing, and QA, as required accomplishing results with minimal guidance.
  • Must be able to respond to changing priorities with minimum disruption.
  • Must possess organizational skills.
  • Ability to troubleshoot problems in a narrow time frame.
  • Required to lift, pull, or carry items of weight & size corresponding with job responsibilities.

WORKING ENVIRONMENT

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Process Engineer

Summary:

The Engineer II, Process Development position is primarily responsible for working in a functional project engineering group within the department, consisting of multiple engineering disciplines. Involved in the design, development, documentation and validation and of new customer products, and modification of existing products including defining requirements, timelines, and deliverables with a focus on prototypes, process development, design verification, clinical builds, training production, and preparation for process validation and manufacturing transfer of products.

Responsibilities:

  • Attends and arranges project meetings to discuss current and future design and development initiatives.
  • May serve as a primary contact with clients on projects of low to moderate complexity.
  • Assist with preparation of proposals and quotations for clients; interface as needed to resolve questions in a timely manner.
  • Assist in preparation and maintaining of project plans to satisfy milestones, deadlines, budgets, and medical device quality regulations with required actions. Have input to project manager for tracking and communicating project status, plans, issues, timelines, action items, and budgets.
  • Responsible for the following project inputs:
    • Feasibility builds, documentation, and testing
    • Equipment selection
    • Process development and documentation
    • Device verification samples and testing
    • Operator training
    • Process Failure Mode Effects Analysis
    • Clinical builds
    • Process validation
  • Involvement in the full design, development, and validation requirements of projects, including:
    • Product design and specification creation, including mechanical and electrical components, assemblies, and packaging
    • Materials sourcing and device prototyping
    • Design verification and validation activities, including data for regulatory submission
    • Manufacturing transfer and support of existing product lines as applicable
  • Reliable, consistent and punctual attendance is an essential function of the job.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • A Bachelors degree in an engineering discipline, minimum 2 years appropriate work experience; or Associates degree in engineering discipline and a minimum or 5 years appropriate work experience; or a minimum 5-7 years relevant work experience; or equivalent
  • Willingness to travel, if required
  • Must maintain high ethical standards
  • Must demonstrate good organizational skills
  • Must be able to read, write and speak fluent English
  • Experience in an engineering/manufacturing environment with mechanical, tool design, and manufacturing processes preferred
  • Strong computer skills, including the MS Office suite and MS Project
  • Must be able to fully interpret technical drawings, blueprints, specifications & illustrations
  • Strong analytical skills, must be able to obtain, evaluate, and apply secondary research information
  • Ability to learn and apply new technology
  • Technical report preparation and formal presentation skills
APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Coil Winding Technician

Summary:

This position is primarily responsible for the manufacturing and assembly of sterile and non-sterile medical devices.  Responsible for setting up and operating workstations, monitoring production rated and running associated systems used in manufacturing products sold to our customers.  May be performing visual and dimensional inspections needed to ensure quality in the products Cirtec manufactures.

Responsibilities:

  • Has the standard function of operating workstations used in manufacturing processes
  • Proficient in set-up and loading component materials into product specific tool
  • Responsible for following established documentation for product manufacturing
  • Demonstrates strict adherence to all safety procedures, GMPs, GDP, quality system guidelines and company policies
  • Accurately documents all work performed on inspection reports and customer travelers
  • Must have a general understanding of the CNC controlled workstations on the production floor
  • Reads and follows process control documents, work instructions, and standard operating procedures
  • Working knowledge of drawings, ability to interpret nomenclature and dimensions
  • Performs in-process visual inspections with and without the use of microscopes in accordance with the requirements stated in the Process Control Document or as otherwise stated on drawings or work instructions
  • Performs various dimensional inspection using specific dies or gauges, or dimensional inspection systems, verniers and micrometers
  • Provides direction within the manufacturing cell to Tech I associates assigned to assist them
  • Performs basic workstation set up and troubleshooting tasks
  • Performs additional duties as required under the direction of the Supervisor
  • Maintains cleanliness of work areas, machines, tools, and equipment
  • Assists Quality Control with inspection duties as required
  • Recognizes quality issues and communicates these issues to Quality and/or Supervisor
  • Complies with company, quality and safety standards, policies, and procedures
  • Other duties as assigned

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • High school diploma or General Education Degree (GED) is required
  • Associates Degree or minimum of 2-4 years’ experience in medical device industry
  • 2+ years’ experience in a technical field
  • Strong attention to detail
  • Knowledge of ISO & FDA requirements
  • Experience with LEAN manufacturing a plus
  • Strong interpersonal and communication skills, including both verbal and written communication
  • Ability to provide detailed information to engineers for determining root cause in order to identify the appropriate corrective actions
  • Ability to track fine details visually and discover defects in the inspected parts
  • Be able to read, write and speak fluent English

WORKING ENVIRONMENT 

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Laser Operator

Summary:

This position is primarily responsible for assembling a range of components into finished goods across one or more production lines ensuring standard documentation, quality, and production rates are met. Works under the direction of the Production Team Leader/Supervisor.

 FIRST SHIFT: Monday-Thursday 5am-3:30pm

WEEKEND SHIFT: Friday-Sunday 6am-6pm

Responsibilities:

  • Complies with company, quality and safety standards, policies, and procedures.
  • Comply with all Good Manufacturing Practices (CGMP) requirements to ensure products are consistently produced and controlled according to the Quality System.
  • Has the responsibility of following established documentation for product manufacturing.
  • Maintains cleanliness of work areas, machines, tools, and equipment.
  • Takes direction within the manufacturing cell from upper-level operators assigned to that cell.
  • Will be proficient in the task of loading components into product specific tools.
  • Primary function of assisting production operators and technicians engaged in processing and product fabrication.
  • Operates a variety of wafer fab equipment in a production environment.
  • Able to manually manipulate fragile wafers on a regular basis.
  • Works with small devices to load fixtures and process equipment.
  • Makes basic measurements and math calculations relative to tolerances, dimensions.
  • As instructed, adjusts machines to achieve conformance with specifications and maximum yield.
  • Performs in-process visual inspections with and without the use of microscopes in accordance with the requirements stated in the Process Control Document or as otherwise stated on drawings or work instructions.
  • Performs pre/post-weld operations such as assembly and part cleaning.
  • Performs workstation set-ups on qualified operations.
  • May perform weld operations.
  • Must accurately document all work performed on inspection reports and customer travelers.
  • Assists in packaging of finished goods as needed.
  • Reliable, consistent, and punctual attendance is an essential function of the job.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • High school diploma or General Education Degree (GED) is required.
  • 1yr. experience in a manufacturing environment preferred but not required.
  • Must be able to read, write and speak fluent English.
  • Must be able to frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.
  • Strong attention to detail.
  • Knowledge of ISO & FDA requirements a plus.
  • Experience with LEAN manufacturing a plus.
  • Ability to work in environment subject to fluctuations in heat, humidity, fumes, odors, dust, and noise.
  • Ability to provide detailed information to assist sustaining engineering in determining root cause in order to identify the appropriate corrective action.
  • Good interpersonal skills to establish and maintain cooperative and effective working relationships.
  • Good written and verbal communication skills.

WORKING ENVIRONMENT 

Work is performed in a manufacturing environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Quality Inspector I (First Shift)

Summary:

This position is primarily responsible for performing receiving, first piece, in-process and final inspection or test on a wide variety of parts and document results. Indicate inspection status, maintain product traceability and non-conforming material control. Participate in internal audits, statistical process control and assist control of process documentation, records and equipment calibration.

This position will be on first shift Monday – Friday 7am-3:30pm 

Responsibilities:

  • Inspect, measure and/or test incoming parts, production first piece, in-process and final product, record results and notify appropriate personnel.
  • Indicate inspection status of parts with assigned labels and stamps.
  • Maintain product identification and traceability.
  • Control non-conforming product in accordance with documented procedures and verify timely corrective and preventative action.
  • Protect product during handling and storage in the performance of work.
  • Monitor factory environmental conditions, record data and alert adverse conditions.
  • Assist with distribution and control of process documentation and quality records.
  • Assist with control of measuring and test equipment calibration.
  • Participate in internal quality audits to verify compliance with documented procedures and specifications, record results and verify audit corrective action.
  • Assist with statistical methods of verifying and controlling process capability.
  • Provide input when required to quality planning for specific projects and products.
  • Provide leadership to production personnel on quality issues.
  • Comply with and reinforce the requirements of the Cirtec Quality System Manual and Standard Operating Procedures, ISO 9002, FDA Quality System Regulations and other customer standards.
  • Follow Occupational Safety and Health regulations, including laser safety practices.
  • Other agreed duties within the Quality Department consistent with training, qualification and experience.
  • Provide Quality Support for the disposition of discrepant material.
  • Provide leadership to production personnel in relation to quality.
  • Provide Quality Control support to Manufacturing & Engineering.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Be able to read, write and speak fluent English
  • High school diploma
  • 3-5 years’ minimum experience in manufacturing, preferably medical devices, with increasing responsibility or a minimum of 5 years’ experience in a manufacturing environment.
  • Certificate/s of training related to this field of work (medical or quality assurance
  • 3 years’ experience as a Quality Control Inspector
  • Proven experience in inspection and documenting results
  • Able to demonstrate competence in interpreting technical drawings & specifications
  • Proficient in the use of microscopes, measuring and test equipment
  • Able to check dimensions, squareness, hole locations, surface relationships, finish material defects and mechanical strength of product following appropriate training
  • Have experience in the use of PC’s and Microsoft Office software applications

PHYSICAL DEMANDS 

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is occasionally required to stand, and/or walk. The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

WORKING ENVIRONMENT 

Work is performed in a manufacturing environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Machinist II - EDM

Summary:

This position is primarily responsible to set up and maintain all set-ups on presses or CNC equipment. A Machinist II should be self-motivated and ensure the product is done on time and of the highest quality possible.  Has excellent trouble shooting ability on both the machine and tooling and can assist the supervisor and/or lead person as well as the programmers with the operation of the department.

Responsibilities:

  • Accurately completes all department paperwork including job travelers, Inspection documentation, work packet information, and tooling request forms
  • Builds quality parts using good working knowledge of blueprints
  • Understands, embraces and follows Cirtec Medical workmanship specs
  • May be required to change tools
  • Actively participates in improving quality programs and team meetings
  • Uses knowledge of the functions of the machines, including tool and work offsets, to adjust them to ensure quality
  • Regularly inspects parts according to process to ensure quality parts are being produced
  • Properly uses all equipment and maintains a clean work area
  • Uses inspection equipment as required
  • Solves problems of quality and efficiency working within the team
  • Maintains a high level of efficient production
  • Maintains a no reject quality level
  • Effectively resolves all problems that arise or seeks assistance in a timely manner
  • Interacts effectively with engineering and quality individuals to solve problems
  • Continually train co-workers to encourage individual growth within company
  • Sets up and runs all jobs within the department
  • Promotes good morale and productivity on the team
  • Increases production and streamlines set-ups for optimum efficiencies and quality
  • Trouble-shoots quality problems by effectively utilizing process controls and corrective actions
  • Maintains a very high level of cleanliness and organization
  • Complies with company, quality and safety standards, policies, and procedures
  • Other duties as assigned

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Meets all criteria for Machinist I
  • High school diploma or GED required
  • Minimum of 2 years Machining experience including setups and troubleshooting required
  • Read, write, and speak fluent English
  • Ability to perform calculations with shop Math
  • Inspection experience using micrometers, calipers, dial indicators, and vision systems
  • Medical Device or component manufacturing experience preferred
  • Possesses extensive knowledge of all phases of machining and equipment
  • Demonstrates good decision making and problem-solving skills
  • Full comprehension of geometric tolerancing
  • On-going job training

WORKING ENVIRONMENT

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Machinist II - Swiss

Summary:

This position is primarily responsible to set up and maintain all set-ups on presses or CNC equipment. A Machinist II should be self-motivated and ensure the product is done on time and of the highest quality possible.  Has excellent trouble shooting ability on both the machine and tooling and can assist the supervisor and/or lead person as well as the programmers with the operation of the department.

Responsibilities:

  • Accurately completes all department paperwork including job travelers, Inspection documentation, work packet information, and tooling request forms
  • Builds quality parts using good working knowledge of blueprints
  • Understands, embraces and follows Cirtec Medical workmanship specs
  • May be required to change tools
  • Actively participates in improving quality programs and team meetings
  • Uses knowledge of the functions of the machines, including tool and work offsets, to adjust them to ensure quality
  • Regularly inspects parts according to process to ensure quality parts are being produced
  • Properly uses all equipment and maintains a clean work area
  • Uses inspection equipment as required
  • Solves problems of quality and efficiency working within the team
  • Maintains a high level of efficient production
  • Maintains a no reject quality level
  • Effectively resolves all problems that arise or seeks assistance in a timely manner
  • Interacts effectively with engineering and quality individuals to solve problems
  • Continually train co-workers to encourage individual growth within company
  • Sets up and runs all jobs within the department
  • Promotes good morale and productivity on the team
  • Increases production and streamlines set-ups for optimum efficiencies and quality
  • Trouble-shoots quality problems by effectively utilizing process controls and corrective actions
  • Maintains a very high level of cleanliness and organization
  • Complies with company, quality and safety standards, policies, and procedures
  • Other duties as assigned

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Meets all criteria for Machinist I
  • High school diploma or GED required
  • Minimum of 2 years Machining experience including setups and troubleshooting required
  • Read, write, and speak fluent English
  • Ability to perform calculations with shop Math
  • Inspection experience using micrometers, calipers, dial indicators, and vision systems
  • Medical Device or component manufacturing experience preferred
  • Possesses extensive knowledge of all phases of machining and equipment
  • Demonstrates good decision making and problem-solving skills
  • Full comprehension of geometric tolerancing
  • On-going job training

WORKING ENVIRONMENT

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Quality Control Inspector (Third Shift)

Summary:

This position will be on third shift Sun-Thurs 11pm-7:30am.

This position is primarily responsible for performing receiving, first piece, in-process and final inspection or test on a wide variety of parts and document results. Indicate inspection status, maintain product traceability and non-conforming material control. Participate in internal audits, statistical process control and assist control of process documentation, records and equipment calibration.

Responsibilities:

  • Inspect, measure and/or test incoming parts, production first piece, in-process and final product, record results and notify appropriate personnel.
  • Indicate inspection status of parts with assigned labels and stamps.
  • Maintain product identification and traceability.
  • Control non-conforming product in accordance with documented procedures and verify timely corrective and preventative action.
  • Protect product during handling and storage in the performance of work.
  • Monitor factory environmental conditions, record data and alert adverse conditions.
  • Assist with distribution and control of process documentation and quality records.
  • Assist with control of measuring and test equipment calibration.
  • Participate in internal quality audits to verify compliance with documented procedures and specifications, record results and verify audit corrective action.
  • Assist with statistical methods of verifying and controlling process capability.
  • Provide input when required to quality planning for specific projects and products.
  • Provide leadership to production personnel on quality issues.
  • Comply with and reinforce the requirements of the Cirtec Quality System Manual and Standard Operating Procedures, ISO 9002, FDA Quality System Regulations and other customer standards.
  • Follow Occupational Safety and Health regulations, including laser safety practices.
  • Other agreed duties within the Quality Department consistent with training, qualification and experience.
  • Provide Quality Support for the disposition of discrepant material.
  • Provide leadership to production personnel in relation to quality.
  • Provide Quality Control support to Manufacturing & Engineering.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Be able to read, write and speak fluent English.
  • High school diploma.
  • 3-5 years’ minimum experience in manufacturing, preferably medical devices, with increasing responsibility or a minimum of 5 years’ experience in a manufacturing environment.
  • Certificate/s of training related to this field of work (medical or quality assurance.
  • 3 years’ experience as a Quality Control Inspector.
  • Proven experience in inspection and documenting results.
  • Able to demonstrate competence in interpreting technical drawings & specifications.
  • Proficient in the use of microscopes, measuring and test equipment.
  • Able to check dimensions, squareness, hole locations, surface relationships, finish material defects and mechanical strength of product following appropriate training.
  • Have experience in the use of PC’s and Microsoft Office software applications.

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is occasionally required to stand, and/or walk. The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

WORKING ENVIRONMENT

Work is performed in a manufacturing environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Customer Service Representative

Summary:

This position is primarily responsible for interfacing with Customers, Business Development, Manufacturing Leadership, and Planning as related to incoming orders and delivery dates.  The Customer Service Representative will process orders, prepare correspondences, and fulfill customer needs to ensure customer satisfaction.

Responsibilities:

  • Provide customers with delivery information based on Value Stream Meeting (VSM) driven from the planning team and update dates within M2M (Enterprise Resource Planning System).
  • Handle daily calls and correspondence with customers and sales reps on purchase orders/sales orders.
  • Keep records of customer interactions, process customer accounts and file documents.
  • Prepare and provide customer open order reports as required.
  • Work with Business Development on new and revised quotes for new and revised purchase orders.
  • Contribute to team effort by accomplishing related results as needed.
  • Communicate with internal and external customers in a cooperative and professional manner.
  • Build sustainable relationships of trust thorough open and interactive communication.
  • Assist to help Cirtec meet sales order promise date(s).
  • Be proactive in representing the customer to reach and maintain a high level of customer satisfaction.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Proven customer support experience
  • Customer orientation and ability to adapt/respond to different types of characters
  • Excellent communication
  • Ability to multi-task, prioritize and manage time effectively.
  • High school diploma or equivalent
  • Top Skills & Proficiencies: Customer Service, ERP, Product Knowledge, Quality Focus, Documentation Skills, Listening Skills, Phone Skills, Resolving Conflict, Multitask, Patience, Positive Attitude, Attention to Detail, People Oriented, Analysis, Problem Solving, Organizational Skills, Ability to Work Under Pressure, Computer Skills

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: None

WORKING ENVIRONMENT

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounter while performing the essential functions of this position.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Sr. Maintenance Technician

Summary:

This position is primarily responsible for all preventative and corrective maintenance on equipment located in the production areas.   Maximum emphasis is placed on positive response to the concerns and needs of the company and its environmental health and safety. This is a hands-on position that the equipment maintenance technician works independently.

Responsibilities:

  • Perform required Machine services activities driven by work orders and project plans.
  • Diagnose and repair machines.
  • Manage and perform preventative maintenance program.
  • Source and acquire parts and service to support repairs.
  • Work safely and maintain a safe work area for others.
  • Provide guidance to contractors and others regarding work required to be performed.
  • Safely use chemicals while performing assigned tasks.
  • Lock/Out Tag Out of equipment when necessary.
  • Able to work independently when performing assigned tasks.
  • Support of production manufacturing by conducting basic and advanced trouble shooting assessments pertaining to equipment issues.
  • Understand and trouble shoot digital electronics, PLC trouble shooting, and apply knowledge to trouble shoot electrical devices and read AC and DC circuits.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • High School Diploma or equivalent
  • Technical training in CNC machine types
  • Three or more years of machine mechanical/electronics experience
  • Understanding of machining and metrology
  • Experience in CNC, electronics, hydraulics, and pneumatics
  • Must be able to use basic hand and power tools
APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Document Control Specialist

Summary:

This position may be located at the Cirtec Los Gatos, CA or Brooklyn Park, MN site.  The Document Control Specialist implements and maintains the Engineering Change Notice System. These changes will include product improvements, repairs, and new product development. Coordinates the interaction between engineering, manufacturing, field operations, and marketing to ensure appropriate changes are documented. Provides documentation such as good manufacturing practices (GMP) and good laboratory practices (GLP) procedure manuals and change authorization in accordance with company policies and government regulations.

Responsibilities:

  • Responsible for issuing part numbers and ECN’s and processing documents into the QMS software (i.e. Master Control, Agile, etc.)
  • Responsible for communicating with customer for obtaining ECN approval.
  • Responsible for compiling and maintaining control records such as release drawings, project documents, quality system documents and manufacturing documents.
  • Responsible for making electronic changes to documents, release documents, and notifies affected departments.
  • Responsible for maintaining related Document Control files.
  • Responsible for ensuring documents are filed correctly and maintained per established procedures.
  • Perform database searches, minor data analysis, and reporting to assist Quality Assurance team.
  • Maintain logs and update CAPA, NCMR, Complaint and other Quality Systems files.
  • Prepare reports and memorandums.
  • Ensure Proper upkeep of quality records and documents.
  • Coordinates Training program, which includes facilitating the training and input results into the training QMS system.
  • Complies with company, quality and safety standards, policies, and procedures.
  • Other duties as assigned.

Qualifications:

  • 2-3 years of Document Control experience in the Medical Device Industry required.
  • Prior experience with PLM software system, such as Master Control or Oracle Agile is preferred.
  • Strong knowledge in implementing, processing, and maintaining Cirtec and Customers documentation in ERP and PLM Software System.
  • Extremely detail-oriented work habits.
  • Flexible and motivated attitude.
  • Proficient with MS Word, Excel.
  • Knowledge of document control procedures with data storage, maintenance, revision and archival background.
  • Familiarity with FDA Quality System Regulation (QSR) and ISO 13485.

WORKING ENVIRONMENT

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Materials Coordinator

Summary

A material coordinator maintains production and distribution of product by pulling orders from inventory; delivering production materials and supplies; staging finished product.

Responsibilities:

  • Maintains inventory by identifying, labeling, and placing materials and supplies in stock, recording location of inventory.
  • Locates materials and supplies by pulling and verifying materials and supplies listed on production orders.
  • Maintains in-process inventory at work centers by delivering and opening materials and supplies.
  • Documents materials and supplies disposition by recording units delivered and location of units.
  • Receives credit-return material and supplies from production by verifying materials and supplies code and lot number and quantity, placing materials in stock.
  • Prepares finished stock for shipment by identifying, pulling, packing, crating, loading, and securing product.
  • Documents product shipment by recording units shipped.
  • Maintains material-handling equipment by completing pre-use inspections, making operator repair notes.
  • Contributes to team effort by accomplishing related results as needed.
  • Review jobs requiring materials via the ERP system.
  • Issue materials to assigned jobs physically and in ERP system.
  • Return materials from completed jobs physically and in ERP system if applicable.
  • Perform monthly cycle count in assigned area(s).
  • Communicate any material shortages to appropriate departments as needed.
  • Prepare outgoing shipments to subcontract suppliers.
  • Copy all documents necessary for and file into the DHR file.
  • Maintain and monitor manual or computerized inventory control system for raw materials and finished stock.
  • Investigate all discrepancies.
  • Perform cycle counts and assist with annual physical inventory as required.
  • Support or provide back-up to Shipping, Production and Inventory Control functions as required.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • High school diploma or GED required, college experience a plus.
  • 2+ years’ experience in materials management desired.
  • Be able to read, write and speak fluent English.
  • Must have good communication skills and work well with people.
  • Attention to detail.
  • Computer literate (MS Office Suite, Syteline, ERP/MRP).
  • Ability to interpret written and verbal work instructions.
  • Able to think creatively, get out of the box and solve problems.
  • Must have good organizational and time management skills.
  • Understanding of scheduling and the importance of details, accuracy, and meeting deadlines.
  • Continually looks for Process Improvement opportunities.
  • Accurate data entry skills and understanding of Inventory Control.
  • Knows how to work safely and looks for opportunities to improve safety.

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee will be on their feet for entire shift.  The employee must be able to lift 50 pounds.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: PPE

WORKING ENVIRONMENT

Work is performed in a warehouse and cleanroom environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Materials Management Supervisor

Summary

The Materials Supervisor is responsible for leading the Materials Management Team.  The Materials Supervisor is responsible to meet safety, quality, delivery, and cost objectives while driving department strategy and continuous improvement.  The role organizes and schedules department activities to meet customer demands, provides direction and motivation to personnel, and ensures training and assistance with adhering to the quality system.

Responsibilities:

  • Provide leadership and direction across material handling team including shipping, receiving, warehousing, kitting (picking), and cycle counting.
  • Ensure proper material handling tasks and relevant system transactions are completed and accuracy of these transactions is maintained.
  • Responsible for ensuring department conformance to legal regulations, ISO 13485 standards, company policies, procedures, and work instructions.
  • Understand the requirements of and ensure compliance with the sites Quality Management System.
  • Prepare and use metrics to improve the team’s safety, quality, delivery, and cost performance.
  • Plan, organize, and schedule department activities to meet production and product development needs.
  • Maintain and ensure compliance to cycle counting program.  Leverage results of cycle counting program to continuously improve processes or ERP data integrity.
  • Knowledge of an ERP system used for material transactions, able to coach others on proper system transactions.
  • Proficient ability to root cause ERP system including transactional data and item master data.
  • Coordinate job rotations and cross training.
  • Manage personnel performance.
  • Collaborate and problem solve with peers, direct reports, and leadership to continuously improve relevant metrics and processes.
  • Maintain goals and deadlines along with maintaining real time feedback on how the team is performing.
  • Preemptively coordinate material and system requirements to ensure minimum amount of downtime and recommend measures to improve efficiency and accuracy of material transactions.
  • Conduct daily Tier 2 team meetings for proper communication and development of team.
  • Develop in depth knowledge of processes within the material handling team.
  • Plan and implement training for personnel, including generic and product specific skills. Act as trainer when necessary.
  • Understand the requirements of and ensure compliance with the sites Quality Management System.
  • Responsible for ensuring that all documentation is completed correctly.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Minimum 2+ year’s supervisory experience in a manufacturing environment, preferably in a medical device manufacturing environment and in leadership role.
  • Be able to read, write and speak fluent English.
  • Excellent communication and interpersonal skills.
  • Outstanding organizational and leadership skills.
  • Experience with monitoring, managing, reporting, and driving metrics.
  • Associates degree or equivalent experience in a related field.
  • Computer literate (MS Office Suite, ERP system experience).
  • Understanding and implementation of Lean Manufacturing and/or Six Sigma for process improvement and problem solving.
  • Strong knowledge of ERP/MRP business functions, demonstrated use of root causing or troubleshooting transactional data in an ERP system.
  • Able to prioritize and manage multiple responsibilities.
  • Experience in technical report writing and verbal communication skills.

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: PPE

WORKING ENVIRONMENT

Work is performed in a manufacturing environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Sr. Program Manager

Summary

Cirtec Medical is a vertically integrated, full-service outsource partner, bringing more than three decades of expertise to every phase of the product development lifecycle for complex medical devices, including state-of-the-art product design, development and manufacturing. We partner with our customers to bring medical devices to market quickly, predictably and cost-effectively.

The Senior Program Manager, based out of our headquarters in Brooklyn Park, MN, will be mainly responsible for leading and managing development and manufacturing transfer of complex Class II and III medical devices.

Responsibilities:

  • Leads and manages development and manufacturing transfer of complex Class II and III medical devices including active implants, implantable leads, surgical devices and external use devices.
  • Generates and maintains detailed project plans, task lists and project risk registers that enable the team to execute activities based on well-defined prioritization.
  • Manages cross-functional team assigned to the functional segment to ensure successful completion of program goals and milestones, and adequate utilization of resources.
  • Tracks program health in terms of schedule, budget, and technical risks and issues. Prepares and presents comprehensive project status reports to internal and external stakeholders.
  • Proactively anticipates program risks and issues, and carefully formulates and implements risk mitigations and corrective/preventive actions.
  • Creates and maintains Design History File per internal company procedures, FDA Design Control (21 CFR 820) and ISO 13485 requirements.
  • Supports project team in establishing and maintaining product requirements and test plans.
  • Contributes to development, quality and risk management activities, and acts as backup to engineers and technical staff on assigned programs as required.
  • Serves as the principal contact with external customers. Coordinates and directs customer meetings and visits, and day-to-day customer communication.
  • Manages internal resources to meet program goals and milestones. Works with internal management to ensure appropriate resources have been assigned.
  • Assists business development team with definition of program scope, timeline, and budget to support preparation of proposals, quotations, and change orders for customers.
  • Manages, mentors and provides guidance to other program manager(s) in the functional group.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Minimum BS in Biomedical / Mechanical / Electronics / Computer Engineering with at least 10 years of experience within the medical device industry.
  • Minimum 5 years of experience in project / program management of medical device development.
  • Experience with neuromodulation devices, active implant devices and/or implantable lead assemblies highly preferred.
  • Demonstrated ability to lead medical device development programs from early-stage design through verification/validation, and transfer to production.
  • Must possess strong understanding and working knowledge of ISO 13485 and FDA 21CFR820 based Quality Systems and Design Control.
  • Must be able to interpret technical drawings, product requirements, design specifications and relevant technical documents.
  • Ability to condense and communicate complex technical ideas, project status and risks to internal and external stakeholders.
  • Must have proficiency in MS Project and other MS Office software.
  • Must be able to read, write and speak fluent English, and must possess excellent communication skills, both written and oral.

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Laser Technician

Summary

This position is responsible for the safe and functional operation of laser cutting and welding equipment.  Will be responsible for developing manual or CAD programs required to cut or weld components.  Will assist in the development of tooling and fixtures required.

Responsibilities:

  • Provide process training to production operators.
  • Perform characterizations, IQ’s, OQ’s, PQ’s, and validations.
  • Provide Laser samples when appropriate to support sales effort.
  • Provide assistance to Engineering to develop laser quotations and manufacturing procedures.
  • Develop CNC programming using a camming software to efficiently meet print requirements.
  • Assist Engineering in designing tooling for production.
  • Interface with Quality to develop inspection procedures to verify acceptability of components.
  • Maintain and promote laser and team safety.
  • Evaluate and recommend alternative manufacturing methods.
  • Maintain and encourage other to maintain a clean and orderly work area.
  • Research and recommend capital equipment for the yearly budget.
  • Ensure laser maintenance program is 100% up to date.
  • Provides leadership to the team and interrelates well with all areas of the company.
  • Effectively resolves all problems that arise or seek assistance in a timely manner.
  • Assists the Team Manager in developing highly skilled individuals to be high quality efficient operators.
  • Performs duties in a manner to promote good department morale with the team.
  • Trains team members and new employee on machines and department procedures.
  • Maintains schedules of machines to best meet customer requirements based on meeting daily production schedule as supplied by M2M and Production Control.
  • Demonstrates responsibility for department efficiency, quality, pre-production planning, process control, corrective actions, cleanliness and safety.
  • Ensures that job BOM’s are accurate and tooling is ordered on timely manner.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Recent pulsed laser cutting experience.
  • Experience with high tolerance cutting, welding and drilling of metals.
  • Set up of laser parameters.
  • Experience or a desire to learn CAD/CAM software.

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: PPE

WORKING ENVIRONMENT

Work is performed in a manufacturing environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Manufacturing Engineer

Summary:

This position is primarily responsible for developing and implementing robust cost-effective manufacturing processes and methods in accordance with product specifications and Class III medical device quality standards.  This position recommends and implements improvements to sustained production processes, methods, and controls; as well as coordinates the launch of new products into pilot production.

Responsibilities:

  • Improves manufacturing processes, methods and controls for cost reduction, quality improvements and efficiency for both sustained and new products.
  • Prepares engineering change orders and coordinates the deployment of changes including training operation team members.
  • Improve manufacturing process instructions, product flow, assembly methods, space allocation, product quality and safety performance for both sustained and new products.
  • Coordinates the manufacturing launch of new products including establishing yield targets, run rates, training needs, and evaluating results.
  • Develop and qualify various tools and equipment required for manufacturing processes.
  • Performs product and process analysis for cost reduction, quality improvement and improved efficiency.
  • Utilizing tools associated with risk management (e.g., PFMEA) to identify potential risks and the associated corrective actions.
  • Supporting required equipment qualification and process validations (IQ, OQ and PQ).
  • Troubleshoot manufacturing processes when defects occur.  Determine root cause and implement effective containment and countermeasures.
  • Disposition non-conforming products and develop re-work procedures.
  • Communicate with customers regarding process improvements and production changes.
  • Represent manufacturing on cross functional teams.
  • Participate in Kaizen events and drive continuous improvement efforts.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Bachelor’s degree in Engineering or related field.
  • Knowledge of manufacturing and assembly processes.
  • Excellent verbal and written communication skills.
  • Fluency in English.
  • Minimum 2-5 years of experience with Class II or III Medical devices, FDA standards, ISO 13485 and GMP principles.
  • Must be able to read blueprints and interpret technical specifications and illustrations.
  • Association with supporting documents including, ECN’s, process deviation, non-conformances, stop shipment notifications and all associated quality related documents.
  • Strong computer skills associated with MS Office suite, Minitab, and SolidWorks a plus.
  • Experience associated with continuous improvement activities, including participations and/or facilitating Kaizen events using lean manufacturing principles.
  • The ability to understand a range of engineering functions and procedures.
  • Interpersonal, presentation and communication skills.
  • The capacity to work well under pressure and take on new challenges.
  • Organizational and time management skills.
  • Project management skills and the ability to work to tight deadlines.

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: PPE

WORKING ENVIRONMENT

Work is performed in an office and manufacturing environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Quality Engineer

Summary:

This position is primarily responsible for monitoring and auditing the quality of all manufactured goods in a medical device industry. Will work to not only find defects, but also to find the cause of the defect and develop a solution. Interact with customers and suppliers in support of engineering projects.

Responsibilities:

  • Provide Quality Engineering support for engineering project development.
  • Provide Quality Project Management support as needed for product transfers from development to validation.
  • Validation System Owner responsible for the development and management of the validation master plan along with the validation determination.
  • Develop and maintain Validation Standard Operating Procedures.
  • Develop and maintain project Quality Plan for assigned projects.
  • Develop protocols, perform statistical analyses, and write reports for validations and formal process development, which requires quality-engineering involvement such as DOEs.
  • Support the development and implementation of IQ (Installation Qualification) and OQ (Operational Qualification) protocols to ensure compliance with the Quality System.
  • Provide Quality Engineering support for manufacturing.
  • CAPA (Corrective and Preventative Action) system owner responsible for the support of the corrective action system and procedures.
  • Interact with customers and suppliers to resolve CAPA investigations and in support of manufacturing.
  • Provide Quality Support for the disposition of material.
  • Provide Quality Project Management Support as needed for product transfers from validation to production.
  • Vendor approval and maintain and assess vendor performance data (i.e. SCAR/on time).
  • Review and document procedure changes for quality requirements and compliance with the quality system.
  • Develop quality systems and procedures as needed.
  • Audit support for third party audits, customer audits and internal audits.
  • Support the implementation of continuous improvement initiatives for production processes.
  • Develop and maintain production quality control plans.
  • Initiate and maintain SPC (Statistical Process Control) for production processes.
  • Provide initiative and support for FMECA (Failure Modes & Effects Criticality Analysis), and DOE (Design of Experiment as applicable.
  • Comply with all work rules including those pertaining to safety, health, quality and Cirtec policies.
  • Back up to Quality Systems Administrator.
  • Perform other duties as necessary.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Analyze and process Information, Promote Process Improvement, Developing Standards, Managing Processes, Manufacturing Methods and Procedures, Supports Innovation.
  • Bachelors of Science or equivalent, preferably in an engineering discipline.
  • Minimum experience in medical/manufacturing environment: 2 years (BS) OR 4 years (AS) OR 7 years (ND).
  • Must be fluent in use of computer systems for the analysis of data, specifically Microsoft Office.
  • Must possess excellent verbal communication, organizational and management skills.
  • Training or equivalent experience in computer use and software-Microsoft Word, Excel, Power Point and Access.
  • Must be able to implement quality programs, interpret the collected data, and present the data to management to drive continuous improvement.

PHYSICAL DEMANDS:

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: PPE

WORKING ENVIRONMENT:

Work is performed in an office and manufacturing environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Quality Calibration Technician

Summary:

This position will be responsible for ensuring Cirtec Medical inspection and testing equipment meets all defined and specified requirements related to their mechanical, electrical, and/or electronic performance, maintenance and calibration to ensure measurement/testing accuracy as applied to the determination of conformity for Quality Assurance and Control of Cirtec Medical products.

Responsibilities:

  • The position will be responsible for ensuring operational adherence and compliance to Cirtec Medical’s Quality Management System (QMS) requirements.   Specific elements of the QMS, as part of daily essential duties and responsibilities, include:
    • Inspection/Test Equipment Calibration & Maintenance,
    • Inspection/Test Equipment Selection and Qualification (Metrology and Gage R&R),
    • Inspection/Test Equipment Identification and Control.
    • Maintenance of the Calibration System to ensure that all inspection, measurement and test equipment, including mechanical, automated, of electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing accurate and valid results.
  • Additional duties and responsibilities include, but are not limited to:
    • Present equipment calibration and maintenance data to internal and external partners/customers.
    • Utilize knowledge of Statistical methods and tools to monitor and report on calibration system status and compliance.
    • Perform periodic audits of the calibration and maintenance systems to ensure compliance, control and accurate reporting of inspection/test equipment.
    • Support site internal and customer-requested auditing activities (Cirtec, Customer and Customer Regulatory Agencies).
    • Support and reinforce Quality Best Practices and GDP/GMP behaviors and continuous improvement efforts within Cirtec Medical.
    • Ensure all personnel are knowledgeable of, and adhere to, the Cirtec Medical Quality Management System and its requirements.
    • Must follow occupational Safety and Health requirements including Personal Protective Equipment (PPE) guidelines and rules.
    • Must maintain an organized and operationally effective work environment.
    • Must adhere to professional workplace attire, time, attendance and leave of absence policies.
    • Other duties and responsibilities as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

Required Education & Experience: 

  • High School Diploma, GED, or equivalent directly transferrable work experience (Manufacturing or Engineering discipline preferred).
  • 1-5 years of Manufacturing Quality experience.

Preferred Qualifications & Experience:

  • Post-Secondary Education/Training/Certification coursework (Manufacturing or Engineering discipline preferred).
  • Quality certification(s) (e.g. ASQ CQT, QCI, etc.).
  • Class I, II and/or III Medical Device manufacturing experience.
  • Other regulated manufacturing industry experience (e.g. Aerospace, Automotive, Defense, Pharmaceutical, etc.)
  • Knowledge of, and experience with, GMP/ISO Standards.

Technical Requirements, Skills and Training:

  • Strong verbal and written English language communication skills.
  • Must demonstrate ability to perform visual inspections (i.e. detect defects) using a microscope and/or magnification visual inspection system.
  • Must demonstrate ability to read manufacturing prints and identify associated specification/characteristics related to inspection and testing to be performed.
  • Must have a fundamental understanding of Quality Management Systems and how Calibration Systems fit in the overall scheme of Manufacturing Quality Control and compliance.
  • Must have a fundamental understanding of Quality philosophies, principles, systems, tools, standards and controls, internal customer service, and professional ethics.
  • Must be able to successfully meet Cirtec Medical-specific positional/functional on-the-job training requirements as provided.
  • Must demonstrate ability and/or experience in computer use and general office software – Microsoft Office (i.e. Outlook, Word, Excel, and PowerPoint).
  • “Hands-on” self-starter with ability to work both independently and as part of a team.
  • Ability to work with a wide variety of functional areas, including R&D, Manufacturing, and QA, as required accomplishing results with minimal guidance.

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: PPE

WORKING ENVIRONMENT
Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Manager Component Engineering

Summary:

This position is primarily responsible to provide functional supervision to the manufacturing engineering department. The ME Manager will assist production technicians and project engineers in defining and developing processes prior to introduction into standard production and lead process improvement efforts and day-to-day support of production products. Managing new components and contract review as these projects transition into operations.

Responsibilities:

  • Provide support & supervision to direct reports for the timely completion of projects, initiatives and key activities.
  • Mentor associates and foster a learning and growth environment.  Perform evaluations at regular intervals.
  • Provides in-put for the budget process.
  • Organize a project plans with required actions.
  • Track and communicate project status, plans, issues, timelines, and action items.
  • Performs tasks to support the project engineers with the development of processes and documentation for new or modified products.
  • Works with technicians on developing processes and documentation for new or modified products.
  • Develops and implements process improvements for current production products.
  • Troubleshoot production processes when part failures occur.
  • Track key programs and report out overall performance.
  • Create action plans that will drive improvement.
  • Coordinate and direct projects, making detailed plans to accomplish goals and directing the integration of technical activities.
  • Communicate with customers on process improvements and/or manufacturing changes.
  • Participates in the development of new products, work with customers to understand their requirements.
  • Lead small projects, including standard work.
  • Prepare periodic reports on project activities.
  • Assign tasks to engineers.
  • Provide support for contract review of new components.
  • Collaborate with the sales team to create new products.
  • Perform other responsibilities duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Incredible problem-solving abilities.
  • Interpersonal skills to manage a team on engineers.
  • Ability to meet deadlines and manage projects.
  • Ability to handle multiple projects at any given time.
  • Above average oral and written communication skills at all levels for technical personnel and customer contact.
  • Operate effectively and maintain professionalism in an environment of deadlines and high workloads and adjust schedule or work hours to meet changes in priorities.
  • Willingness to travel, if required.
  • High ethical standards, good organizational skills.
  • Demonstrated skills with project management tools, methodologies and problem solving.
  • Demonstrated success in leading and managing people in a team-based environment.
  • Must be able to read, write and speak fluent English.
  • Minimum Associates degree or equivalent experience.  Preferred bachelor’s degree in an engineering discipline or equivalent.
  • Minimum 3 years of experience in manufacturing engineering.
  • Strong computer skills, including the MS Office suite.
  • Must be able to read blueprints and interpret technical specifications and illustrations.
  • Above average oral and written communication skills at all levels for technical personnel and client contact.
  • Ability to work independently using available resources.
  • Must have demonstrated organizational skills to manage multiple priorities and schedule revisions.
  • Must be able to use lean methodologies and drive a culture of change.

Physical Demands:

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: PPE

Work Environment:

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Opportunities in Chandler, AZ

Sr. Product Engineer

Summary

Cirtec Medical is a vertically integrated, full-service outsource partner, bringing more than three decades of expertise to every phase of the product development lifecycle for complex medical devices, including state-of-the-art product design, development, and manufacturing. We partner with our customers to bring medical devices to market quickly, predictably, and cost-effectively.

The Senior Product Engineer is based out of our Chandler, AZ office. The Senior Product Engineer is responsible for developing and maintaining test solutions for all internal Cirtec and customer ASIC products. The ideal candidate can develop test solutions on the selected test platforms used by Cirtec such as D10, ASL1K/3K, and/or Catalyst. This position also requires the management of test development and product testing at third party vendors. The candidate will also oversee the production yield and product delivery of ASIC’s and application specific standard products (ASSP).

Responsibilities:

  • Lead creation of test specifications, test verification plans and release of test verification reports
  • Provide product engineering, test engineering and backend support for a product or range of IC products through all phases of product development and production
  • Collaborate with design engineers to develop a post silicon evaluation plan, support bench evaluation and debug of silicon, and support development of production tests
  • Monitor production yield and delivery, and lead troubleshooting and resolution of yield issues
  • Manage test houses and backend vendors, and monitor vendor performance
  • Work closely with quality engineering on root cause investigation, CAPAs or SCARs related to product testing
  • Assist with project management, schedule tracking and allocation of technical resources
  • Other duties as assigned

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Minimum BS in Computer or Electrical Engineering, or in other relevant engineering discipline
  • Minimum 8 years of experience with testing and production of ICs
  • Detailed understanding of diagnostic, product test, failure analysis and debug techniques
  • Good understanding of semiconductor manufacturing, packaging, and testing
  • Solid understanding of circuit design, semiconductor process and device physics
  • Experience working within a Quality Management System (e.g. ISO 13485, ISO 9001) preferred
  • Self-starter with strong communication skills and demonstrated problem solving ability
  • Travel Requirements: Possible need to travel to local or out of state customer or vendor sites

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to sit, talk, and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  Long hours at the computer is often required.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: None

WORKING ENVIRONMENT

Work is performed in an office/manufacturing environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

IC Design Engineer

Summary

Cirtec Medical is a vertically integrated, full-service outsource partner, bringing more than three decades of expertise to every phase of the product development lifecycle for complex medical devices, including state-of-the-art product design, development, and manufacturing. We partner with our customers to bring medical devices to market quickly, predictably, and cost-effectively.

The IC Design Engineer is based out of our Chandler, AZ office. The ideal candidate should have a competent understanding of analog and mixed signal integrated circuit (IC) building blocks through course work or some industry experience. This position requires the ability to demonstrate exceptional problem-solving skills especially as it relates to circuit design. The candidate must also understand the basics of semiconductor devices physics, IC layout and characterization of circuit in electronics laboratories. This individual should be a self-starter and demonstrate the desire and ability to learn new concepts quickly and apply them.

Responsibilities:

  • Understand and implement circuits for medical ASICs, including transistor level circuit design
  • Develop simulation test bench and other test environments
  • Perform top level mixed mode simulations as directed
  • Support development of ASIC qualification hardware and software
  • Support development of low power design, power management, data converters, and energy harvesting
  • Participate in and conduct detailed design reviews
  • Implement post silicon evaluation plan as directed
  • Complete bench evaluation and debug of silicon as directed
  • Support production test development
  • Other duties as assigned

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • BSEE Degree or higher
  • Minimum of 1+ year of experience in IC design related work or a Master’s degree
  • Strong understanding of IC related software tools such as Cadence and Mentor tool sets
  • Ability to use MATLAB and LABVIEW desired but not required
  • Ability to do PCB level design and use of Altium desired but not required
  • Experience characterizing circuit with standard electronics laboratory equipment
  • Strong written and oral technical communications skills

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to sit, talk, and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  Long hours at the computer is often required.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: None

WORKING ENVIRONMENT

Work is performed in an office/manufacturing environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Principal IC Design Engineer

Summary

Cirtec Medical is a vertically integrated, full-service outsource partner, bringing more than three decades of expertise to every phase of the product development lifecycle for complex medical devices, including state-of-the-art product design, development, and manufacturing. We partner with our customers to bring medical devices to market quickly, predictably, and cost-effectively.

The Principal IC Design Engineer is based out of our Chandler, AZ office. The ideal candidate should be able to architect new innovative circuits to solve electronic system challenges. This position will require a person capable of leading IC development projects which would include directing and mentoring other designers, mapping out schedules, resources, and partitioning the design work. Candidate should be able to quickly analyze product proposals and be able to identify critical and challenging design requirements.   The candidate must also understand the basics of semiconductor devices physics, have strong circuit analysis skills, understand good IC layout practices, and implement or guide the characterization of circuits in electronics laboratories.

Responsibilities:

  • Lead design and development of medical ASICs, including transistor level circuit design.
  • Develop product specifications and convert to design specifications.
  • Develop simulation test bench and other test environments.
  • Perform top level mixed mode simulations as directed.
  • Act as the Technical Lead on IC design programs, conduct design reviews, and interface with internal stakeholders and customers to communicate technical updates and program status.
  • Lead innovate designs for low power design, power management, data converters, and energy harvesting.
  • Develop a post silicon evaluation plan, support bench evaluation and debug of silicon, and support development of production tests.
  • Assist with project management, schedule tracking and allocation of technical resources.
  • Assist business development in generating proposals, analyze product proposals and identify critical parameters for implementation.
  • Direct and mentor other design engineers.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Minimum BS in Electrical Engineering. Higher degrees preferred.
  • Minimum 10 years of experience in analog and mixed-signal integrated circuit design.
  • Experience with leading IC design teams and design of large building blocks of ICs.
  • Good understanding of semiconductor manufacturing, packaging, and testing.
  • Travel Requirements: Possible need to travel to local or out of state customer or vendor sites.

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to sit, talk, and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. Long hours at the computer is often required.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: None

WORKING ENVIRONMENT

Work is performed in an office/manufacturing environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Project Manager

Summary

Cirtec Medical is a vertically integrated, full-service outsource partner, bringing more than three decades of expertise to every phase of the product development lifecycle for complex medical devices, including state-of-the-art product design, development and manufacturing. We partner with our customers to bring medical devices to market quickly, predictably and cost-effectively.

The Project Manager, based out of our facility in Chandler, AZ, will be responsible for coordinating and managing activities related to design, production and testing of medical ASICs.

Responsibilities:

  • Manage and coordinate activities related to design and production of ASICs and other electronic assemblies intended for medical devices
  • Generate and maintain project plans, schedules, task lists and project risk registers that enable the team to execute project activities based on well-defined prioritization
  • Coordinate activities across different functional groups within the company, customers and suppliers to ensure successful completion of project goals and milestones
  • Track project health in terms of schedule, budget, and technical risks and issues. Prepares and presents comprehensive project status reports to internal and external stakeholders
  • Proactively anticipate project risks and issues, and carefully formulates and implements risk mitigations and corrective/preventive actions
  • Create and maintain documentation per company procedures and ISO 9001/13485 requirements
  • Coordinates and directs customer meetings and visits, and day-to-day customer communication
  • Interfaces with suppliers to drives schedules and manage priorities
  • Analyze gross profit reports and manage financial aspects of internal and customer programs
  • Analyze relevant information, trends, and data to support decision making
  • Other duties as assigned

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Minimum BS in a science or engineering discipline with 3+ years of industry experience
  • Prior experience with project management highly desired but not required
  • Experience with IC design and/or production desired but not required
  • Ability to interpret product requirements, design specifications and technical documents preferred
  • Ability to communicate complex ideas, project status and risks to internal and external stakeholders
  • Must have proficiency in MS Project and other MS Office software
  • Must be able to read, write and speak fluent English, and must possess excellent communication skills, both written and oral
  • Willingness to travel, if required

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: PPE

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Sr. IC Design Engineer (Digital)

Summary

Cirtec Medical is a vertically integrated, full-service outsource partner, bringing more than three decades of expertise to every phase of the product development lifecycle for complex medical devices, including state-of-the-art product design, development, and manufacturing. We partner with our customers to bring medical devices to market quickly, predictably, and cost-effectively.

The Senior IC Design Engineer is based out of our Chandler, AZ office. The ideal candidate should be able to architect new innovative circuits to solve electronic system challenges. This position will require a person capable of leading IC development projects which would include directing and mentoring other designers, mapping out schedules, resources, and partitioning the design work. Candidate should be able to quickly analyze product proposals and be able to identify critical and challenging design requirements.  The candidate must also understand the basics of semiconductor devices physics, have strong circuit analysis skills, understand good IC layout practices, and implement or guide the characterization of circuits in electronics laboratories.

Responsibilities:

  • Lead design and development of medical ASICs, including transistor level circuit design
  • Develop product specifications and convert to design specifications
  • Develop simulation test bench and other test environments
  • Perform top level mixed mode simulations as directed
  • Act as the Technical Lead on IC design programs, conduct design reviews, and interface with internal stakeholders and customers to communicate technical updates and program status
  • Lead innovate designs for low power design, power management, data converters, and energy harvesting
  • Develop a post silicon evaluation plan, support bench evaluation and debug of silicon, and support development of production tests
  • Assist with project management, schedule tracking and allocation of technical resources
  • Assist business development in generating proposals, analyze product proposals and identify critical parameters for implementation
  • Direct and mentor other design engineers
  • Other duties as assigned

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Requirements:

  • BSEE Degree or higher
  • Minimum 5 years of experience in digital integrated circuit design
  • Experience with leading IC design teams and design of large building blocks of ICs
  • Good understanding of semiconductor manufacturing, packaging, and testing
  • Travel Requirements: Possible need to travel to local or out of state customer or vendor sites
APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Sr. IC Design Engineer (Analog)

Summary

Cirtec Medical is a vertically integrated, full-service outsource partner, bringing more than three decades of expertise to every phase of the product development lifecycle for complex medical devices, including state-of-the-art product design, development, and manufacturing. We partner with our customers to bring medical devices to market quickly, predictably, and cost-effectively.

The Senior IC Design Engineer is based out of our Chandler, AZ office. The ideal candidate should be able to architect new innovative circuits to solve electronic system challenges. This position will require a person capable of leading IC development projects which would include directing and mentoring other designers, mapping out schedules, resources, and partitioning the design work. Candidate should be able to quickly analyze product proposals and be able to identify critical and challenging design requirements.  The candidate must also understand the basics of semiconductor devices physics, have strong circuit analysis skills, understand good IC layout practices, and implement or guide the characterization of circuits in electronics laboratories.

Responsibilities:

  • Lead design and development of medical ASICs, including transistor level circuit design
  • Develop product specifications and convert to design specifications
  • Develop simulation test bench and other test environments
  • Perform top level mixed mode simulations as directed
  • Act as the Technical Lead on IC design programs, conduct design reviews, and interface with internal stakeholders and customers to communicate technical updates and program status
  • Lead innovate designs for low power design, power management, data converters, and energy harvesting
  • Develop a post silicon evaluation plan, support bench evaluation and debug of silicon, and support development of production tests
  • Assist with project management, schedule tracking and allocation of technical resources
  • Assist business development in generating proposals, analyze product proposals and identify critical parameters for implementation
  • Direct and mentor other design engineers
  • Other duties as assigned

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • BSEE Degree or higher
  • Minimum 5 years of experience in analog and mixed-signal integrated circuit design
  • Experience with leading IC design teams and design of large building blocks of ICs
  • Good understanding of semiconductor manufacturing, packaging, and testing
  • Travel Requirements: Possible need to travel to local or out of state customer or vendor sites
APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Sr. Manager, IC Development

Summary

Cirtec Medical is a vertically integrated, full-service outsource partner, bringing more than three decades of expertise to every phase of the product development lifecycle for complex medical devices, including state-of-the-art product design, development and manufacturing. We partner with our customers to bring medical devices to market quickly, predictably and cost-effectively.

Based out of our division in Chandler, AZ, the Senior Design Manager will be mainly responsible for leading ASIC development teams through all phases of product development for low power portable devices including Class II and Class III medical ASICs.

Responsibilities:

  • Manage cross-functional ASIC development projects targeted for medical, sensing, and power management applications.
  • Work closely with Program Management to provide the necessary resources and development tools to successfully bring products to market on-time, on-schedule and to specification.
  • Provide technical guidance to design, product and test engineering teams and participate in design reviews.
  • Proactively identify projects risks and issues, and guide engineering teams to formulate and implement risk mitigations and corrective/preventive actions.
  • Collaborate with Program Managers to create and manage development plans related to ASIC development.
  • Work closely with design team members and vendors to evaluate, recommend and setup CAD tools, lab equipment and technologies to bring products to market efficiently and successfully.
  • Manage internal resources to meet goals and milestones on development programs, and identify additional resource needs to support business growth.
  • Support Business Development team to engage new customers and maintain existing customer relationships.
  • Support Business Development and Applications Engineering teams with definition of program scope, timeline, and budget to support preparation of quotations and change orders for customers.
  • Leads continuous improvement of company’s ASIC design capabilities and technologies based on emerging industry trends.
  • Provide career guidance, feedback, mentoring and support to the ASIC Design Team consisting of Analog, Digital and Mask designers.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • BS in Electrical or Computer Engineering or in an equivalent engineering discipline. Advanced degrees preferred.
  • 5+ years’ experience as an ASIC Design Engineer.
  • 5+ years’ experience as a Technical Design Lead or IC Design Manager.
  • Experience with development of low power battery operated ASICs preferred.
  • Experience in analog design preferred.
  • Solid understanding of the ASIC Design flow from specification development to production release.
  • Must be able to read, write and speak fluent English, and must possess excellent communication skills, both written and oral.
APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Opportunities in Enfield, CT

Materials Coordinator

Summary:

This position is primarily responsible for inventory control, job order material usage reconciliation, job closings, and inventory reconciliation. Coordinating with purchasing and production to ensure the inventory is accurate and appropriate to meet demands. Perform duties within the production and inventory control department as required.

Responsibilities:

  • Review jobs requiring materials via the ERP system.
  • Issue materials to assigned jobs physically and in ERP system.
  • Return materials from completed jobs physically and in ERP system.
  • Perform monthly cycle count in assigned area(s).
  • Communicate any material shortages to appropriate departments as needed.
  • Prepare outgoing shipments to subcontract suppliers.
  • Close all production jobs, verifying material issues before doing so.
  • Copy all documents necessary for and file into the DHR file.
  • Prepare closed jobs with necessary documentation for AR invoicing.
  • Provide customers with Inventory reports of their material as requested.
  • Create “customer supplied” materials purchase orders.
  • Support customer service with releasing job orders to the floor.
  • Maintain and monitor manual or computerized inventory control system for raw materials and finished stock.
  • Investigate all discrepancies.
  • Perform cycle counts and assist with annual physical inventory as required.
  • Support or provide back-up to Shipping, Production and Inventory Control functions as required.
  • Reliable, consistent, and punctual attendance is an essential function of the job.
  • Other duties as assigned.

Qualifications:

  • Minimum five years’ experience in a manufacturing environment, two years of which include operation of an automated inventory control system.
  • Inventory management and control disciplines
  • Computerized inventory record keeping systems4-year degree plus10 years complex assembly manufacturing engineering work experience in a regulated environment.

WORKING ENVIRONMENT

Work is performed in a manufacturing environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

Cirtec Medical is interested in every qualified candidate who is eligible to work in the United States. However, at this time we are not able to sponsor visas for this particular position.

Cirtec Medical’s immigration sponsorship policy is applied in a nondiscriminatory fashion regardless of race, gender, ethnic origin, or any other classification protected by law. Cirtec Medical is an equal opportunity employer.

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Operator Assembler II- 2nd Shift

Summary:

This position is primarily responsible for operating workstations and associated systems used in the manufacturing of products sold to our customers. This position is expected to work with lower-level Operators along with higher level Technicians to effectively meet or exceed expectations for product quality and production rates. In this position they must have a basic knowledge of how to set up and operate workstations, perform visual and dimensional inspections needed to manufacture the products at Cirtec.

Responsibilities:

  • Comply with all Good Manufacturing Practices (CGMP) requirements to ensure products are consistently produced and controlled according to the Quality System.
  • Has the responsibility of following established documentation for product manufacturing.
  • Maintains cleanliness of work areas, machines, tools, and equipment.
  • Takes direction within the manufacturing cell from upper-level operators assigned to that cell.
  • Will be proficient in the task of loading components into product specific tools.
  • Performs in-process visual inspections with and without the use of microscopes in accordance with the requirements stated in the drawings or work instructions.
  • Performs pre/post-weld operations such as assembly and part cleaning.
  • Performs workstation set-ups on qualified operations.
  • Performs basic workstation set up and troubleshooting tasks.
  • Performs various dimensional inspection using specific gauges, dimensional inspection systems, verniers and micrometers.
  • Makes basic measurements and math calculations relative to tolerances, dimensions.
  • Working knowledge of drawings, ability to interpret nomenclature and dimensions.
  • Provides direction within the manufacturing cell to associates assigned to assist them.
  • Assists Quality Control with inspection duties as required.
  • Recognizes quality issues and communicates these issues to Quality and/or Supervisor.
  • Must accurately document all work performed on inspection reports and customer travelers.
  • Assists in packaging of finished goods as needed.
  • Reliable, consistent, and punctual attendance is an essential function of the job.
  • Other duties as assigned.

Qualifications:

  • High school diploma or General Education Degree (GED) is required.
  • 3-5 years’ experience in medical device industry, preferred but not required.
  • Be able to read, write and speak fluent English.
  • Must be able to frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.
  • Strong attention to detail.
  • Knowledge of how to set up and operate workstations.
  • Ability to provide information to engineers for determining root cause in order to identify the appropriate corrective actions.
  • Knowledge of performing visual and dimensional inspections.
  • Strong interpersonal skills to establish and maintain cooperative and effective working relationships.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Operator Assembler II

Summary:

This position is primarily responsible for operating workstations and associated systems used in the manufacturing of products sold to our customers. This position is expected to work with lower-level Operators along with higher level Technicians to effectively meet or exceed expectations for product quality and production rates. In this position they must have a basic knowledge of how to set up and operate workstations, perform visual and dimensional inspections needed to manufacture the products at Cirtec.

Responsibilities:

  • Comply with all Good Manufacturing Practices (CGMP) requirements to ensure products are consistently produced and controlled according to the Quality System.
  • Has the responsibility of following established documentation for product manufacturing.
  • Maintains cleanliness of work areas, machines, tools, and equipment.
  • Takes direction within the manufacturing cell from upper-level operators assigned to that cell.
  • Will be proficient in the task of loading components into product specific tools.
  • Performs in-process visual inspections with and without the use of microscopes in accordance with the requirements stated in the drawings or work instructions.
  • Performs pre/post-weld operations such as assembly and part cleaning.
  • Performs workstation set-ups on qualified operations.
  • Performs basic workstation set up and troubleshooting tasks.
  • Performs various dimensional inspection using specific gauges, dimensional inspection systems, verniers and micrometers.
  • Makes basic measurements and math calculations relative to tolerances, dimensions.
  • Working knowledge of drawings, ability to interpret nomenclature and dimensions.
  • Provides direction within the manufacturing cell to associates assigned to assist them.
  • Assists Quality Control with inspection duties as required.
  • Recognizes quality issues and communicates these issues to Quality and/or Supervisor.
  • Must accurately document all work performed on inspection reports and customer travelers.
  • Assists in packaging of finished goods as needed.
  • Reliable, consistent, and punctual attendance is an essential function of the job.
  • Other duties as assigned.

Qualifications:

  • High school diploma or General Education Degree (GED) is required.
  • 3-5 years’ experience in medical device industry, preferred but not required.
  • Be able to read, write and speak fluent English.
  • Must be able to frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.
  • Strong attention to detail.
  • Knowledge of how to set up and operate workstations.
  • Ability to provide information to engineers for determining root cause in order to identify the appropriate corrective actions.
  • Knowledge of performing visual and dimensional inspections.
  • Strong interpersonal skills to establish and maintain cooperative and effective working relationships.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Operator Assembler I - 2nd Shift

Summary:

This position is primarily responsible for assembling a range of components into finished goods across one or more production lines ensuring standard documentation, quality, and production rates are met. Works under the direction of the Production Team Leader/Supervisor.

Responsibilities:

  • Complies with company, quality and safety standards, policies, and procedures.
  • Comply with all Good Manufacturing Practices (CGMP) requirements to ensure products are consistently produced and controlled according to the Quality System.
  • Has the responsibility of following established documentation for product manufacturing.
  • Maintains cleanliness of work areas, machines, tools, and equipment.
  • Takes direction within the manufacturing cell from upper-level operators assigned to that cell.
  • Will be proficient in the task of loading components into product specific tools.
  • Able to manually manipulate fragile wafers on a regular basis.
  • Works with small devices to load fixtures and process equipment.
  • Makes basic measurements and math calculations relative to tolerances, dimensions.
  • As instructed, adjusts machines to achieve conformance with specifications and maximum yield.
  • Performs in-process visual inspections with and without the use of microscopes in accordance with the requirements stated in the Process Control Document or as otherwise stated on drawings or work instructions.
  • Performs pre/post-weld operations such as assembly and part cleaning.
  • Performs workstation set-ups on qualified operations.
  • Must accurately document all work performed on inspection reports and customer travelers.
  • Assists in packaging of finished goods as needed.
  • Reliable, consistent, and punctual attendance is an essential function of the job.
  • Other duties as assigned.

Qualifications:

  • High school diploma or General Education Degree (GED) is required.
  • 1 year experience in a manufacturing environment preferred but not required.
  • Must be able to read, write and speak fluent English.
  • Must be able to frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.
  • Strong attention to detail.
  • Knowledge of ISO & FDA requirements a plus.
  • Experience with LEAN manufacturing a plus.
  • Ability to work in environment subject to fluctuations in heat, humidity, fumes, odors, dust, and noise.
  • Ability to provide detailed information to assist sustaining engineering in determining root cause in order to identify the appropriate corrective action.
  • Good interpersonal skills to establish and maintain cooperative and effective working relationships.
  • Good written and verbal communication skills.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Operator Assembler I

Summary:

This position is primarily responsible for assembling a range of components into finished goods across one or more production lines ensuring standard documentation, quality, and production rates are met. Works under the direction of the Production Team Leader/Supervisor.

Responsibilities:

  • Complies with company, quality and safety standards, policies, and procedures.
  • Comply with all Good Manufacturing Practices (CGMP) requirements to ensure products are consistently produced and controlled according to the Quality System.
  • Has the responsibility of following established documentation for product manufacturing.
  • Maintains cleanliness of work areas, machines, tools, and equipment.
  • Takes direction within the manufacturing cell from upper-level operators assigned to that cell.
  • Will be proficient in the task of loading components into product specific tools.
  • Able to manually manipulate fragile wafers on a regular basis.
  • Works with small devices to load fixtures and process equipment.
  • Makes basic measurements and math calculations relative to tolerances, dimensions.
  • As instructed, adjusts machines to achieve conformance with specifications and maximum yield.
  • Performs in-process visual inspections with and without the use of microscopes in accordance with the requirements stated in the Process Control Document or as otherwise stated on drawings or work instructions.
  • Performs pre/post-weld operations such as assembly and part cleaning.
  • Performs workstation set-ups on qualified operations.
  • Must accurately document all work performed on inspection reports and customer travelers.
  • Assists in packaging of finished goods as needed.
  • Reliable, consistent, and punctual attendance is an essential function of the job.
  • Other duties as assigned.

Qualifications:

  • High school diploma or General Education Degree (GED) is required.
  • 1 year experience in a manufacturing environment preferred but not required.
  • Must be able to read, write and speak fluent English.
  • Must be able to frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.
  • Strong attention to detail.
  • Knowledge of ISO & FDA requirements a plus.
  • Experience with LEAN manufacturing a plus.
  • Ability to work in environment subject to fluctuations in heat, humidity, fumes, odors, dust, and noise.
  • Ability to provide detailed information to assist sustaining engineering in determining root cause in order to identify the appropriate corrective action.
  • Good interpersonal skills to establish and maintain cooperative and effective working relationships.
  • Good written and verbal communication skills.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Opportunities in Los Gatos, CA

Mechanical Engineer

Summary:

Cirtec Medical is a vertically integrated, full-service outsource partner, bringing more than three decades of expertise to every phase of the product development lifecycle for complex medical devices, including state-of-the-art product design, development, and manufacturing. We partner with our customers to bring medical devices to market quickly, predictably, and cost-effectively.

As a Mechanical Engineer, you will work with product development teams to bring complex mechanical designs for implants, surgical devices and external electromechanical devices from concept to market.

Responsibilities:

  • Creates mechanical designs and applies engineering knowledge and skills as technical engineer during all phases of design and development
  • Generates and maintains computer-aided drawings (CAD) using Solidworks, schematics and component specifications to document mechanical designs
  • Participates in hands-on fabrication and testing of prototypes using bench testing, animal and/or cadaver studies to evaluate product designs, and recommend and implement design modifications
  • Perform detailed design reviews and tolerance analyses to achieve desired product performance, cost, reliability, and manufacturability requirements
  • Develop test plans and protocols and executes prototype testing and design verification testing
  • Creates engineering-level process instructions, bill of materials and related documentation
  • Assists in release and revision control of component drawings, specifications and other design documentation through the document control system
  • Effectively interfaces with suppliers to source and fabricate components
  • Participates in risk management activities (e.g. DFMEA) and implements risk mitigation strategies
  • Other duties as assigned

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • BS in Mechanical or Biomedical Engineering, or an equivalent engineering discipline
  • Minimum 2 years’ experience with development of medical devices
  • Experience and working knowledge of medical device design control process preferred
  • Proficiency with CAD design using SolidWorks required
  • Excellent communication skills both written and oral

PHYSICAL DEMANDS 

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: PPE

WORKING ENVIRONMENT 

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Sr. Engineer, Systems

Summary:

Based out of our facility in Los Gatos, CA, the Systems Engineer will be responsible for system-level design, integration and testing of mechanical, electronic and software designs for Class II and III medical devices. The Systems Engineer will work with a multi-disciplinary engineering team including software, electrical and mechanical engineers, and other functions to ensure high quality and on-time product introductions. This team player will have experience with multi-tasking in a high energy fast paced environment. The person needs to have strong self-starting qualities to independently manage coordination of multiple projects to ensure timely and successful completion.

Responsibilities:

  • Create and manage product requirements and engineering specifications, and generate test plans and protocols during the life cycle of the product development.
  • Research, identify and apply relevant medical development standards, such as IEC 60601, IEC 62304, ISO 14708, etc. towards product requirements, risk management and test plans.
  • Generate test plans and protocols for characterization and verification, and develop new test methods and fixtures.
  • Lead and perform system, sub-system and component level characterization and functional testing, and coordinate compliance testing at external test labs.
  • Perform design analysis and conduct regular design reviews with hardware and software teams.
  • Collaborate with program managers to create and manage development plans and project plans related to electronic and software systems development.
  • Lead and contribute in creation of risk management documentation, including FMEAs.
  • Develop and maintain documentation (e.g. specifications, designs, test plans and reports, etc.) required for medical product. Design History Files. Manage and assist in creation of ­manufacturing process instructions, bills of material, quality inspection, and related documentation.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • BS in Electrical / Computer / Biomedical Engineering or in an equivalent engineering discipline.
  • Minimum 5-7 years of experience as Electrical Systems Engineer with medical device product development (or a similarly regulated environment).
  • Strong hands-on engineering skills and experience with bench testing and troubleshooting.
  • Experienced with requirements management software, e.g. JAMA preferred.
  • Experience with software programming to develop test environments and fixtures.
  • Excellent oral, written, and presentation communication skills.

PHYSICAL DEMANDS 

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.   The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

WORKING ENVIRONMENT 

Work is performed in an office and manufacturing environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Sr. Software Engineer

Summary:

Cirtec Medical is a vertically integrated, full-service outsource partner, bringing more than three decades of expertise to every phase of the product development lifecycle for complex medical devices, including state-of-the-art product design, development and manufacturing. We partner with our customers to bring medical devices to market quickly, predictably and cost-effectively.

Based out of our facility in Los Gatos, CA, the Sr. Software (Embedded) Engineer will be mainly responsible for development and integration of embedded software for novel Class 2/3 medical devices.

Responsibilities:

  • Lead and coordinate design, implementation and testing of embedded software.
  • Participate in software system architecture development and document software requirements and development plan.
  • Perform detailed design analysis and reviews with hardware engineering team to achieve product performance, cost, reliability and manufacturability requirements.
  • Track software related issues and lead resolution of issues with a well-documented and methodical approach.
  • Develop software test and verification plans and protocols, and conduct prototype testing and verification testing.
  • Work closely with hardware engineering team to debug/integrate software with hardware.
  • Collaborate with program managers to create and manage development plans and project plans related to software development.
  • Lead and contribute towards creation of software design history file, risk management documentation, issue tracking, configuration management, etc.
  • Develop and maintain relevant documentation (for e.g. specifications, designs, test plans and reports, etc.) required for medical product Design History Files.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • BS in Electronics or Computer Engineering or in an equivalent engineering discipline.
  • Minimum 10 years’ experience in embedded software development in the medical device industry or a highly regulated industry.
  • Experience with Texas Instruments and Zarlink microcontrollers, DSP, SPI.
  • Extensive experience programming in C and C++
  • Strong HW / SW bring-up and debugging skills.
  • Capable of working independently in a hardware lab with oscilloscopes, signal generators, power supplies and other test equipment.
  • Knowledge and understanding of IEC 60601 and IEC 62304 and other relevant medical device regulatory standards highly preferred but not mandatory.
  • Must be able to read, write and speak fluent English, and must possess excellent communication skills, both written and oral.

PHYSICAL DEMANDS 

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: None

WORKING ENVIRONMENT 

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Operations Manager

Summary:

Cirtec Medical is a vertically integrated, full-service outsource partner, bringing more than three decades of expertise to every phase of the product development lifecycle for complex medical devices, including state-of-the-art product design, development and manufacturing. We partner with our customers to bring medical devices to market quickly, predictably and cost-effectively.

Based out of our headquarters in Los Gatos, CA, the Operations Manager will be mainly responsible for managing the manufacturing operations and overseeing the production staff and supply chain team.

Responsibilities:

  • Manage and coordinate the activities of production staff and supply chain team. Provide technical guidance on issues pertaining to manufacturing operations.
  • Provide sustaining support to manufacturing lines and ensure all equipment are operational and efficient. Monitor manufacturing lines routinely to ensure efficiency and output metrics are achieved.
  • Oversee qualification and validation activities for new materials, processes, equipment, and products into manufacturing. Lead transfer activities in accordance with customer needs and company goals.
  • Actively collaborate with quality and engineering teams to resolve manufacturing and/or supplier quality issues for clinical and sustained production.
  • Serve as the principal contact for sustained manufacturing customers, and actively collaborate with the customer to understand demand, and create/update resource plans to meet that demand.
  • Oversee materials core team to identify and forecast engineering and sustained manufacturing demand for materials, plan inventory levels and ensure timely flow of materials to meet demand.
  • Manages and supports production and test equipment maintenance, qualification and calibration.
  • Oversee the hiring, training, and monitoring of operations staff. Mentor and motivate team members to excel at their level of performance and to achieve their highest potential.
  • Leads investigation and troubleshooting of designs and processes when defects occur to determine root cause, and implement effective containment and preventive measures.
  • Lead planning and scale-up of operational activities to support the growth of the business.
  • Develop and implement health and safety policies to ensure a risk-free and safe work condition. Conduct risk assessments to analyze risks and operational hazards.
  • Proactively identify and lead continuous improvement activities, Serve as the Operations team representative on the internal CAPA board.
  • Perform other responsibilities duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • BS in an Engineering or a relevant discipline.
  • 10+ years of experience working in an manufacturing and/or operations environment, with minimum 5 years of experience in medical device manufacturing.
  • Prior experience with operations management or with leading manufacturing teams highly preferred.
  • Experience with lean manufacturing techniques, value stream mapping, and continuous improvement methodologies preferred.
  • Strong knowledge of GMP and ISO 13485 regulations.
  • Strong computer skills, including the MS Office suite.
  • Must be able to read, write and speak fluent English, and must possess excellent communication skills, both written and oral.
  • Must have demonstrated organizational skills to manage multiple priorities and schedules.

PHYSICAL DEMANDS 

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: PPE

WORKING ENVIRONMENT 

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Sr. Mechanical Engineer

Summary:

Cirtec Medical is a vertically integrated, full-service outsource partner, bringing more than three decades of expertise to every phase of the product development lifecycle for complex medical devices, including state-of-the-art product design, development and manufacturing. We partner with our customers to bring medical devices to market quickly, predictably and cost-effectively.

As a Senior Mechanical Engineer, you will lead a dedicated product development teams to bring complex mechanical designs from concept to market. You will be responsible for the development of novel medical devices including structural heart implants, minimally invasive catheter-based devices and external electromechanical capital equipment.

Responsibilities:

  • Lead product development of complex mechanical and electromechanical medical devices through various phases of concept feasibility, detailed design and verification
  • Lead creation of product requirements and design specifications, and determine applicable regulatory standards and ensures appropriate integration into product requirements
  • Generate and maintain computer-aided drawings (CAD) using Solidworks, schematics and component specifications to document mechanical designs
  • Drive hands-on fabrication and testing of prototypes using bench testing, animal and/or cadaver studies to evaluate product designs, and recommend and implement design modifications
  • Perform detailed design reviews and tolerance analyses to achieve product performance, cost, reliability and manufacturability requirements
  • Serve as the main technical contact with customers and communicate directly with customers to understand project / product needs, and present technical updates, risks and issues
  • Effectively interface with and manage suppliers to fabricate prototype and final components
  • Develop test plans and protocols, and executes prototype testing and design verification testing
  • Lead and contribute towards creation of risk management documentation, including FMEAs
  • Create engineering-level manufacturing process instructions, bill of materials and related manufacturing documentation
  • Proactively anticipate technical risks and issues, and formulate and implement risk mitigations and corrective/preventive actions
  • Assist program managers in developing and maintaining project plans, and in tracking program health in terms of schedule, budget, and technical risks and issues
  • Collaborate with cross-functional team members to create and maintain Design History file per internal company procedures, FDA Design Control (21 CFR 820) and ISO 13485 requirements
  • Mentor and provide guidance to other engineers and technicians
  • Other duties as assigned

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • BS in Mechanical / Biomedical Engineering with minimum 5 years of experience within the Medical Device industry
  • Experience with product development of structural heart implants and catheter-based devices highly preferred
  • Strong understanding of mechanical component manufacturing (i.e. injection molding, machining, sheet metal fabrication, etc.)
  • Proven experience and proficiency using Solidworks for mechanical design
  • Strong working knowledge and understanding of GD&T and mechanical design standards
  • Excellent communication skills, both written and oral

PHYSICAL DEMANDS 

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: PPE

WORKING ENVIRONMENT 

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Electrical Engineer

Summary:

Based out of our facility in Los Gatos, CA, the Electrical Engineer will be responsible for system-level and module-level development and testing of electronic and software designs for Class 2/3 medical devices, and for supporting new product introduction and design transfer activities. The Electrical Engineer will work with a multi-disciplinary engineering team including software, electrical and mechanical engineers, and other functions to ensure high quality and on-time product introductions.

This team player will have experience with multi-tasking in a high energy fast paced environment. The person needs to have strong self-starting qualities to independently manage coordination of multiple projects to ensure timely and successful completion.

Responsibilities:

  • Collaborate with cross-functional team to support development, testing and design transfer of novel medical devices involving electronics and software.
  • Create and manage test method development, scripting and fixturing requirements, and generate test plans and protocols during the life cycle of the product development.
  • Research, identify and apply relevant test methods to accomplish design verification, compliance testing, and manufacturing goals.
  • Generate test plans and protocols for characterization and verification, and develop new test methods and fixtures.
  • Lead and perform system, sub-system and component level characterization and functional testing, coordinate compliance testing at external test labs, and automated manufacturing testing.
  • Generate and maintain test scripts for supporting manual and automated testing.
  • Proactively discover gaps in requirements or processes and lead effort of developing test and process requirements to close gaps.
  • Develop manufacturing test protocols and automated test solutions to validate performance and operation of PCBAs, Electronic assemblies and electro-mechanical systems.
  • Support release of electronic component specifications and drive engineering change order activities and release documentation.
  • Support supply chain team with sourcing, inspection plans and testing of electronic components, PCBAs, cable assemblies, etc.
  • Develop and maintain documentation (e.g. test plans and reports, etc.) required for medical product Design History Files. Manage and assist in creation of ­manufacturing process instructions, work instructions, design and code review meeting minutes, and related documentation.

Qualifications:

  • BS in Electrical / Computer / Software Engineering or in an equivalent engineering discipline.
  • Minimum 3-5 years of experience as Electrical or Software or Test Engineer in the medical device industry (or a similarly regulated environment).
  • Strong hands-on engineering skills and experience with test method development, bench testing and troubleshooting in a regulated environment.
  • Experienced with requirements management software, JAMA preferred.
  • Experienced with software programming to develop test environments and fixtures.
  • Experienced with LabView or similar and controlling automated testing through scripting languages (e.g. Python, C++, etc.)
  • Experience releasing verification and manufacturing test protocols in regulated environment.
  • Excellent oral, written, and presentation communication skills.

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

WORKING ENVIRONMENT

Work is performed in an office and manufacturing environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

Protective Clothing Required: PPE

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Document Control Specialist

Summary:

This position may be located at the Cirtec Los Gatos, CA or Brooklyn Park, MN site.  The Document Control Specialist implements and maintains the Engineering Change Notice System. These changes will include product improvements, repairs, and new product development. Coordinates the interaction between engineering, manufacturing, field operations, and marketing to ensure appropriate changes are documented. Provides documentation such as good manufacturing practices (GMP) and good laboratory practices (GLP) procedure manuals and change authorization in accordance with company policies and government regulations.

Responsibilities:

  • Responsible for issuing part numbers and ECN’s and processing documents into the QMS software (i.e. Master Control, Agile, etc.)
  • Responsible for communicating with customer for obtaining ECN approval.
  • Responsible for compiling and maintaining control records such as release drawings, project documents, quality system documents and manufacturing documents.
  • Responsible for making electronic changes to documents, release documents, and notifies affected departments.
  • Responsible for maintaining related Document Control files.
  • Responsible for ensuring documents are filed correctly and maintained per established procedures.
  • Perform database searches, minor data analysis, and reporting to assist Quality Assurance team.
  • Maintain logs and update CAPA, NCMR, Complaint and other Quality Systems files.
  • Prepare reports and memorandums.
  • Ensure Proper upkeep of quality records and documents.
  • Coordinates Training program, which includes facilitating the training and input results into the training QMS system.
  • Complies with company, quality and safety standards, policies, and procedures.
  • Other duties as assigned.

Qualifications:

  • 2-3 years of Document Control experience in the Medical Device Industry required.
  • Prior experience with PLM software system, such as Master Control or Oracle Agile is preferred.
  • Strong knowledge in implementing, processing, and maintaining Cirtec and Customers documentation in ERP and PLM Software System.
  • Extremely detail-oriented work habits.
  • Flexible and motivated attitude.
  • Proficient with MS Word, Excel.
  • Knowledge of document control procedures with data storage, maintenance, revision and archival background.
  • Familiarity with FDA Quality System Regulation (QSR) and ISO 13485.

WORKING ENVIRONMENT

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Opportunities in Lowell, MA

Technician, Machine Maintenance

Summary:

This position is primarily responsible for all preventative and corrective maintenance on equipment located in the fab and plating areas.  Maximum emphasis is placed on positive response to the concerns and needs of the company and its environmental health and safety. This is a hands-on position that the equipment maintenance technician works independently and is capable of being successful in a matrix organization.

Responsibilities:

  • Responsible for preventative and corrective maintenance on all fab / plating area tool sets, including component disassembly / assembly / repair.
  • Responsible for identifying needed parts for repairs / preventative maintenance.
  • Perform preventative maintenance as instructed by the Computer Machine Maintenance System (CMMS).
  • Complete work orders in the specified time, directed by the CMMS.
  • Keep work area clean and presentable while performing assigned tasks.
  • Lock/Out Tag Out of equipment when necessary or instructed by Manager.
  • Performing Coolant tank Cleaning.
  • Properly hand and store chemicals and hazardous waste.
  • Maintain written logs of maintenance and repairs in our online system.
  • Ensure that facility maintenance requirements are consistently met.
  • Promptly respond to facilities related issues and ensure effective resolution.
  • Keep apprised of current regulations to effectively address and ensure compliance with ADA (Americans with Disabilities Act), OSHA (Occupational Safety & Health Administration), fire codes requirements, and Material Management for Hazardous Material.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Minimum 3 – 5 years’ experience in performing preventative and corrective maintenance on semiconductor related equipment.   Similar equipment experience will be considered.
  • Able to troubleshoot electronic circuits to a component level.
  • Familiar with vacuum systems.
  • Must have good computer, written and oral skills.
  • Manual dexterity and visual acuity are required to perform responsibilities.
  • Must be able to lift 60 lbs.
  • Must be willing to work some weekends, alternating coverage with other maintenance techs.
  • Must be legally authorized to work in the United States.
  • Must be able to work well as a team.
  • Must be able to work overtime as required.

WORKING ENVIRONMENT

Work is performed in a manufacturing environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Engineer II, Process Development

Summary:

The Engineer II, Process Development position is primarily responsible for working in a functional project engineering group within the department, consisting of multiple engineering disciplines. Involved in the design, development, documentation and validation and of new customer products, and modification of existing products including defining requirements, timelines, and deliverables with a focus on prototypes, process development, design verification, clinical builds, training production, and preparation for process validation and manufacturing transfer of products.

Responsibilities:

  • Attends and arranges project meetings to discuss current and future design and development initiatives.
  • May serve as a primary contact with clients on projects of low to moderate complexity.
  • Assist with preparation of proposals and quotations for clients; interface as needed to resolve questions in a timely manner.
  • Assist in preparation and maintaining of project plans to satisfy milestones, deadlines, budgets, and medical device quality regulations with required actions. Have input to project manager for tracking and communicating project status, plans, issues, timelines, action items, and budgets.
  • Responsible for the following project inputs:
    • Feasibility builds, documentation, and testing
    • Equipment selection
    • Process development and documentation
    • Device Verification samples and testing
    • Operator training
    • Process Failure Mode Effects Analysis
    • Clinical builds
    • Process Validation
  • Involvement in the full design, development, and validation requirements of projects, including:
    • Product design and specification creation, including mechanical and electrical components, assemblies, and packaging
    • Materials sourcing and device prototyping
    • Design verification and validation activities, including data for regulatory submission
    • Manufacturing transfer and support of existing product lines as applicable
  • Reliable, consistent and punctual attendance is an essential function of the job.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • A Bachelor’s degree in an engineering discipline, minimum 2 years appropriate work experience; or Associates degree in engineering discipline and a minimum or 5 years appropriate work experience; or a minimum 5-7 years relevant work experience; or equivalent
  • Willingness to travel, if required
  • Must maintain high ethical standards
  • Must demonstrate good organizational skills
  • Must be able to read, write and speak fluent English
  • Experience in an engineering/manufacturing environment with mechanical, tool design, and manufacturing processes preferred
  • Strong computer skills, including the MS Office suite and MS Project
  • Must be able to fully interpret technical drawings, blueprints, specifications & illustrations
  • Strong analytical skills, must be able to obtain, evaluate, and apply secondary research information
  • Ability to learn and apply new technology
  • Technical report preparation and formal presentation skills

WORKING ENVIRONMENT

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

SMT Engineer II

Summary:

This position is primarily responsible for working in a functional project engineering group within the department, consisting of multiple engineering disciplines. Involved in the design, development, documentation and validation and of new customer products, and modification of existing products including defining requirements, timelines, and deliverables with a focus on prototypes, process development, design verification, clinical builds, training production, and preparation for process validation and manufacturing transfer of products.

Responsibilities:

  • Attends and arranges project meetings to discuss current and future design and development initiatives.
  • May serve as a primary contact with clients (internal and external).
  • Assist with preparation of proposals and quotations. May be required to interface with clients to resolve questions in a timely manner.
  • Assist in preparation and maintaining of project plans to satisfy milestones, deadlines, budgets, and medical device quality regulations with required actions. Have input to project manager for tracking and communicating project status, plans, issues, timelines, action items, and budgets.
  • Develop process and capacity utilization strategies for SMT assembly operations.
  • Develop paste printing, automated paste inspection, component pick and place, reflow profile, and inspection processes.
  • Assists is the selection of SMT/SMD equipment
  • Operates SMT equipment in support on production and process development
  • Identify the root cause of quality issues and develop corrective action plans to improve.
  • Ensure the production readiness of SMT processes within the PCBA cycle.
  • Design optimum production processes such as solder paste selection, reflow profiles, stencil designs, component feeder set up methodology, and selective soldering techniques.
  • Optimize equipment set up and programming sequences.
  • Write DFM reports in support of customer proposals.
  • Manipulates electronic data files using Gerber, OB++, various CAD packages, and 3D modeling such as AutoCAD and Solidworks
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Must be able to fully interpret technical drawings, blueprints, specifications & illustrations.
  • Able to follow clean room and ESD policies, become familiar with and practice 6S principles in order to maintain a safe, neat, and orderly workplace.
  • Willingness to travel, if required.
  • Must maintain high ethical standards.
  • Must demonstrate good organizational skills.
  • Must be able to read, write and speak fluent English.
  • A Bachelor’s degree in an engineering discipline and minimum 4 years appropriate work experience; or Associates degree in engineering discipline and a minimum or 6 years appropriate work experience; or a minimum of 10 years relevant work experience; or equivalent.
  • Must have extensive knowledge with surface mount and through-hole technologies.
  • Must be familiar with IPC/EIA J-STD-001 and IPC-A-610.
  • Must have working knowledge of all SMT assembly and inspection processes.
  • Must have a working knowledge of printed circuit board CAD data and assembly equipment programming software, and databases.
  • Strong computer skills, including the MS Office suite and MS Project.
  • Strong analytical skills, must be able to obtain, evaluate, and apply secondary research information
  • Ability to learn and apply new technology.
  • Technical report preparation and formal presentation skills.

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: Standard PPE and cleanroom garments

WORKING ENVIRONMENT

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Sr. Engineer, Process Development

Summary:

The Sr. Engineer, Process Development position is primarily responsible for working in a functional project engineering group within the department, consisting of multiple engineering disciplines. Involved in the design, development, documentation and validation and of new customer products, and modification of existing products including defining requirements, timelines, and deliverables with a focus on prototypes, process development, design verification, clinical builds, training production, and preparation for process validation and manufacturing transfer of products.

Responsibilities:

  • Attends and arranges project meetings to discuss current and future design and development initiatives.
  • May serve as a primary contact with clients on projects of moderate complexity.
  • Assist with preparation of proposals and quotations for clients; interface as needed to resolve questions in a timely manner.
  • Assist in preparation and maintaining of project plans to satisfy milestones, deadlines, budgets, and medical device quality regulations with required actions. Track and communicate project status, plans, issues, timelines, action items, and budgets.
  • Provide guidance and direction to coworkers on areas of technical expertise.
  • Troubleshoot production processes as required.
  • Evaluate and select appropriate test methods for product requirements.
  • Responsible for the following project inputs:
    • Feasibility builds, documentation, and testing
    • Equipment selection, process development and documentation
    • Device Verification samples and testing
    • Operator training
    • Process Failure Mode Effects Analysis
    • Clinical builds
    • Process Validation
  • Involvement in the full design, development, and validation requirements of projects, including:
    • Product design and specification creation, including mechanical and electrical components, assemblies, and packaging
    • Materials sourcing and device prototyping
    • Design verification and validation activities, including data for regulatory submission
    • Manufacturing transfer and support of existing product lines as applicable
  • Reliable, consistent and punctual attendance is an essential function of the job
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • A Bachelor’s degree in an engineering discipline with 5 years of relevant experience; Associates degree in an engineering discipline w/10 years of relevant experience or equivalent.
  • Experience in an engineering/manufacturing environment with a mix of mechanical design, tool design and manufacturing process experience.
  • Willingness to travel, if required.
  • Must maintain high ethical standards.
  • Must demonstrate good organizational skills.
  • Ability to train new engineering employees on project engineering activities and Cirtec policies and procedures.
  • Must be able to read, write and speak fluent English.
  • Strong computer skills, including the MS Office suite and MS Project.
  • Must be able to fully interpret technical drawings, blueprints, specifications, illustrations, and written documents.
  • Strong analytical skills; must be able to obtain and evaluate secondary research information.
  • Ability to learn and apply new technology.
  • Moderate knowledge of engineering principles, technical writing, material properties, good tooling practices, and statistics.

WORKING ENVIRONMENT

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Industrial Engineer II

Summary:

The Operational Excellence program seeks to minimize waste and variation through Lean and Six Sigma approaches leading to improved production processes and systems that operate at high efficiency levels. The Industrial Engineer (IE) is responsible for identifying and leading execution of a wide range of Continuous Improvement projects.  The IE leads, facilitates, executes, and manages team training initiatives and projects.  The IE will utilize knowledge of COGs, gross margin, facility design, material handling equipment, labor management, staff planning and project management to identify, quantify, prioritize and recommend improvement projects that align with the Operational Excellence team charter and organizational goals and objectives.

Responsibilities:

  • Participates in identification and planning of department goals implementation of initiatives intended to improve quality, cost, and delivery.
  • Serves as an engaging and collaborative teacher/trainer providing internal standardized lean training and consulting support for Lean & Six Sigma tools, data mining and presentation with heavy emphasis on MS Excel.
  • Supports the philosophy of waste reduction through implementation of Lean and Six Sigma approaches within the organization.
  • Utilizes tools and methodologies including, but not limited to time studies, line balancing, setup time reductions, line layout creation, flow improvement, 5S, standard work, visual factory improvements and accountability systems.
  • Collaborates with cross-functional teams.
  • Evaluates, designs, and implements new production line and facility layouts.
  • Leads and/or facilitates A3 projects and teams.
  • Collaborates with others on Key Process Indicator development and implementation.
  • Seeks out continuous improvement opportunities, weighs their value based on benefit, investment, and risk, and prioritizes work accordingly.
  • Participates in project work to help customers and operators achieve sustainable results.
  • Complies with company, quality and safety standards, policies, and procedures.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • BS degree in Industrial Engineering highly preferred.  Advanced degree a plus
  • 2-5 years manufacturing experience, preferably in medical device and/or machining.
  • Strong MS Excel knowledge
  • Six Sigma or Lean Certification (ASQ or IASSC) is a plus
  • Strong analytical, problem solving and project management skills
  • Must be a learner; adaptable to accept new changes in the field of lean manufacturing and desire to remain knowledgeable regarding the latest developments in field
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment
  • Ability to influence and engage others to accomplish projects
  • Must be a clear communicator of ideas in both written and oral forms to all levels of the organization
  • Strong organizational abilities; can multitask and prioritize to meet deadlines in timely manner
  • Ability to travel to other sites (approximately 5-10%)

WORKING ENVIRONMENT

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Electrical Engineer II

Summary:

The Electrical Engineer II position is primarily responsible the development of electro-mechanical designs for the creation of medical device products.

Responsibilities:

  • Performs design and analysis to achieve product performance, cost, reliability, manufacturability requirements
  • Performs circuit design including analog input signal conditioning, embedded control, motor control, telemetry, and inductive power coupling
  • Designs battery controlled devices
  • Designs power supplies, battery systems, power management and charging circuits
  • Designs and/or leads design of printed circuit assemblies and electromechanical assemblies
  • Trouble shoots designs and maintains engineering notebook
  • Specifies and/or designs embedded software and firmware for test and verification purposes
  • Develops electronic and electromechanical system requirements (specifications) and development plans
  • Interfaces with and manages suppliers to fabricate prototype and final design components
  • Participates in architecture design, subsystem requirements partitioning, requirements management and configuration management during product development
  • Builds, tests, debugs, and maintains configuration of prototype assemblies
  • Develops and executes formal design verification tests
  • Develops documentation of specifications, designs, test plans and reports for inclusion in medical product Design History Files
  • Creates and releases medical device manufacturing process instructions, bills of material, lot history travelers, and related documentation
  • Participates in the development of quality inspection and manufacturing process instructions for electronic assemblies
  • Reliable, consistent and punctual attendance is an essential function of the job
  • Other duties as assigned

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Minimum BS/MS in an engineering discipline; with 5+ years’ experience in a product development role.
  • Familiarity and experience with electronic design automation tools: e.g.: schematic capture, analog and digital circuit simulation, tolerance and worst-case analysis, etc.
  • Experienced in at least two of the following areas:
  • Embedded control design
  • Embedded software and firmware design
  • Power supply and battery management circuits
  • Design of Lithium Ion Battery Packs
  • Motor control: stepper, BLDC controls and position sensors
  • Analog and digital sensor interfacing and signal processing
  • Excellent communication skills both written and oral
  • Experience with Altium Designer
  • Experience with Systems and Electronic CAD and simulation tools (e.g.: MATLAB, SPICE, Labview, etc.
  • Printed circuit layout experience
  • FPGA design experience
  • Experience within the Medical Device or a highly regulated industry
  • Knowledge of Medical Device Verification and Validation for compliance with FDA guidance

WORKING ENVIRONMENT

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Production Planner

Summary:

This position is primarily responsible for assisting with planning routines and methods for the innovation and re-engineering of company products. The position will include the standard production planning responsibilities including coordination with purchasing, materials, scheduling, customer service, and project teams as required by production demand. This position is also responsible for strategic projects as assigned.

Responsibilities:

  • Coordinate production workflow for one or multiple products.
  • Plan and prioritize operations to ensure maximum performance and minimum delay.
  • Determine manpower, equipment and raw materials needed to cover production demand.
  • Assign workers and other staff to particular production operations.
  • Schedule shift according to production needs.
  • Monitor jobs to ensure they will finish on time and within budget.
  • Address issues when they arise aiming for minimum disruption.
  • Obtain output information (number of finished products, percentage of defectives etc.)
  • Prepare and submit status and performance reports.
  • Keep paperwork organized.
  • Collaborate with quality control, warehouse, and other staff.
  • Complies with company, quality and safety standards, policies, and procedures.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Bachelor’s degree or equivalent and/or five to ten years’ experience in Manufacturing (i.e., resource planning, production control, manufacturing performance standards). CPM/APICS qualifications preferred.
  • Must be able to read, write, and speak fluent English.
  • Minimum 5 years’ experience in a manufacturing environment.
  • Possess a broad experience with planning systems and mid-level volume production requirements, preferably, in a medical device manufacturing environment. Prior experience in the implementation of ERP/MRP systems is a plus.
  • Knowledge of computerized inventory and MRP systems, word processing and spreadsheet/database software required.
  • Proven ability to effectively interface with internal and external customers to understand month to month production requirements and ensure adjustments are communicated to all parties.
  • Must be detail-oriented with excellent organizational skills as well as excellent oral and written communication skills.
  • Must be self-motivated with the ability to work independently with minimal supervision.
  • Knowledge of cGMP’s, ISO and FDA requirements a plus.
  • Experience in medical device or pharmaceutical industry preferred.
  • Prior experience in a Contract Manufacturing Operation (CMO) is preferred.
  • Preferred candidate will have relevant experience in planning for operational performance and regulatory compliance.

WORKING ENVIRONMENT

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Program Manager

Summary:

The Program Manager is primarily responsible for managing and coordinating development and manufacturing transfer of complex medical devices.

Responsibilities:

  • Manages and coordinates development and manufacturing transfer of complex components, sub-assemblies and finished medical devices.
  • Generates and maintains detailed project plans, task lists and project risk registers that enable the team to execute activities based on well-defined prioritization.
  • Coordinates activities across different functional groups to ensure successful completion of program goals and milestones.
  • Tracks program health in terms of schedule, budget, and technical risks and issues. Prepares and presents comprehensive project status reports to internal and external stakeholders.
  • Proactively anticipates program risks and issues, and carefully formulates and implements risk mitigations and corrective/preventive actions.
  • Creates and maintains Design History file per internal company procedures, FDA Design Control (21 CFR 820) and ISO 13485 requirements.
  • Supports project team in establishing and maintaining product requirements and test plans.
  • Contributes to development, quality and risk management activities, and acts as backup to engineers and technical staff on assigned programs as required.
  • Serves as the principal contact with external customers. Coordinates and directs customer meetings and visits, and day-to-day customer communication.
  • Manages internal resources to meet program goals and milestones. Works with internal management to ensure appropriate resources have been assigned.
  • Assists business development team with definition of program scope, timeline, and budget to support preparation of proposals, quotations, and change orders for customers.
  • Reliable, consistent and punctual attendance is an essential function of the job.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Minimum BS in a relevant engineering discipline with at least 5 years of experience within the medical device industry.
  • Minimum 2 years of experience in project / program management of medical device development.
  • Experience with metals processing and Nitinol-based devices preferred but not required.
  • Demonstrated ability to lead medical device development projects from design through verification / validation, and transfer to production.
  • Must possess strong understanding and working knowledge of ISO 13485 and FDA 21CFR820 based Quality Systems and Design Control.
  • Must be able to interpret technical drawings, product requirements, design specifications and relevant technical documents.
  • Ability to condense and communicate complex technical ideas, project status and risks to internal and external stakeholders.
  • Must have proficiency in MS Project and other MS Office software.
  • Must be able to read, write and speak fluent English, and must possess excellent communication skills, both written and oral.
  • Willingness to travel, if required.

WORKING ENVIRONMENT

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Business Services Manager

Summary:

This position is primarily responsible for supporting sales and marketing by driving the sales quoting process. This includes detailed technical analysis and proposal writing to support RFQ and grants applications.  Will work closely with Business Development, Operations and Finance to develop quotes, product pricing models and assist in the construction of overall program timelines.  In addition will be accountable for analyzing sales opportunities and support the approval process.  Will be responsible for developing dashboards and other strategic sales reporting tools.

Responsibilities:

  • Develop and implement quote process for new development and manufacturing opportunities.
  • Develop quote metrics.
  • Oversee all quoting activities, including existing manufacturing repricing to ensure financial objectives are being met.
  • Coordinate all quoting activities for Cirtec’s operations.
  • Develop quote metrics and report to management periodically.
  • Meet with perspective customers to understand needs and develop quote based on inputs.
  • Assist with sales pipeline management.
  • Complies with company, quality and safety standards, policies, and procedures.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Technical Bachelor’s Degree, MBA preferred
  • Strong background in Class II and III medical devices (neuromodulation and cardiac assist knowledge a plus).
  • Strong industry involvement a plus.
  • Program Management skills.
  • Microsoft Project and general software skills required (Word, Excel, PowerPoint etc.)
  • Excellent communication skills both written and verbal.
  • Strong financial background.
  • CM Operational experience.
  • Experience building product cost models.
  • Experience quoting design and development activities.

WORKING ENVIRONMENT

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Manager, Engineering

Summary:

The Manager, Engineering position is primarily responsible with functional supervision to the engineering department, consisting of research and development engineers and technicians, and mechanical designers.   The Engineering Manager will serve as Project Manager and/or technical lead for projects including validation and documentation of new product services, and expansion of existing product services including defining requirements, timelines, and deliverables.

Responsibilities:

  • Provide support & supervision to direct reports for the timely completion of projects, initiatives and key activities.
  • Mentor associates and foster a learning and growth environment.  Perform evaluations at regular intervals.
  • Serve as secondary contact with clients; instilling confidence in our technical capabilities and quality products.
  • Responsible for reviewing the Quality Management System for adequacy, effectiveness and suitability through attending, participating and assigning action items at the Management Review meetings.
  • Ensure team is performing under the Cirtec quality system and with good engineering practices.
  • Ensure R&D, design and tooling resources are meeting project needs in both availability and talent in a multi-project environment.
  • Ensure that projects stay on schedule and are fully documented as required by medical device regulatory agencies.
  • Oversee the process of developing new or modified products ensuring compliance to internal, regulatory, and customer requirements.
  • Provide leadership for teams that will execute projects in all aspects of the development process to include: requirement and specification definition, risk management, design development, process development, sourcing and supply chain, prototype builds, device verification testing, process qualification, and transfer into manufacturing.
  • Manage day-to-day oversight of engineering support of the manufacturing operation for assigned customers after product release as necessary.
  • Assist with preparation of proposals and quotations for clients; interface as needed to resolve questions in a timely manner.
  • Reliable, consistent and punctual attendance is an essential function of the job.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • A Bachelors’ degree in an engineering discipline or equivalent.
  • Minimum 7 years’ experience in an engineering/manufacturing environment.
  • Demonstrated ability to lead engineering teams successfully from early stage development to production.
  • Strong analytical skills, must be able to obtain and evaluate secondary research information.
  • Ability to meet deadlines and manage projects across many departments.
  • Ability to handle multiple projects and customers at any given time.
  • Above average oral and written communication skills at all levels for technical personnel and customer contact.
  • Operate effectively and maintain professionalism in an environment of deadlines and high workloads and adjust schedule or work hours to meet changes in priorities.
  • High ethical standards, good organizational skills.
  • Demonstrated skills with project management tools, methodologies and problem solving.
  • Demonstrated success in leading and managing people in a team-based environment.
  • Must maintain high ethical standards.
  • Must demonstrate good organizational skills.
  • Ability to train new engineering employees Cirtec policies and procedures.
  • Must be able to read, write and speak fluent English.
  • Strong computer skills, including the MS Office suite and MS Project.
  • Must be able to fully interpret technical drawings, blueprints, specifications and illustrations.
  • Technical report preparation and formal presentation skills.
  • Ability to learn and apply new technology.
  • Exceptional knowledge of engineering principles, technical writing, material properties, good tooling practices, and statistics.
  • Willingness to travel, if required.

WORKING ENVIRONMENT

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Supervisor, Plating

Summary:

This position is primarily responsible to direct the development and implementation of activities in the plating lab production area(s) to meet production goals, quality, and cost objectives. Plan, organize and schedule production activities to meet customer demands. Provide direction, leadership, and motivation to production personnel, including training and assistance with adhering to the quality system.

Responsibilities:

  • Adhere to all safety and Good Laboratory Practice regulations as well as company policies.
  • Must be able to execute Standard Operating Procedures and be able to keep detailed, organized records and complete the required documentation.
  • Implementing and ensuring adherence to various safety programs.
  • Helping to establish and ensure adherence to standard operating procedures.
  • Working with the broader technical team to develop preventative maintenance schemes for various pieces of equipment.
  • Actively managing our chemical inventory with regard to proper storage, use, upkeep, labeling, and disposal.
  • Monitoring satellite waste sites and managing waste removal with our hazardous waste vendor.
  • Coordinating with third party contractors and vendors to perform various calibration and maintenance activities.
  • Working with facilities to improve lab infrastructure.
  • Establishing and maintaining housekeeping best practices for our lab.
  • Regularly auditing lab facilities for safety, cleanliness, and organization.
  • Maintaining inventory of PPE, hardware, and consumables.
  • Providing technical support on various projects throughout the team
  • Supervise the day-to-day operation of the department to insure smooth flow of production.
  • Oversees the scheduling of staff to ensure production schedules are met.
  • Performs duties in compliance with all applicable regulatory and accredited agencies and cGMP expectations.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Be able to read, write and speak fluent English.
  • BS in Chemistry, Biology, medical laboratory science or similar.
  • Minimum 3+ year’s supervisory experience in a manufacturing environment, preferably in a medical device manufacturing environment and in leadership role
  • Computer literate (MS Office Suite, Syteline)
  • Understanding and implementation of Lean Manufacturing and Six Sigma for process improvement and problem solving.
  • Strong knowledge of ERP/MRP business functions.
  • Able to prioritize and manage multiple responsibilities.
  • Knowledge of chemistry principles and methods with the ability to interpret results and an ability to communicate effectively.
  • Experience in technical report writing and verbal communication skills.

WORKING ENVIRONMENT

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Engineering Technician I

Summary:

The Engineering Technician I position is primarily responsible for utilizing state of the art equipment for the development of life changing medical devices.  The ideal candidate will be comfortable operating a variety of equipment including, but not limited to; lasers, injection molders, reflow machines as well as an array of test equipment while adhering to the quality requirements of the company. In addition, this position will work with the design and process teams to ideate, create, and build first prototypes. This individual is essential in the maturation of these prototypes and their progress through the development.  Lastly, the technician must feel comfortable providing candid feedback to the development team to ensure success in later phases of the program.

Responsibilities:

  • Run equipment tests, collect data and analyze data with the engineering team.
  • Make recommendations on how to improve the quality or efficiency of a process based on data and observation.
  • Ability to diagnose and solve problems with jobs in a timely manner.
  • Assist in training employees on equipment and assembly skills.
  • Interact effectively and assist engineering in improving quality and solving problems.
  • Develop processes and procedures for projects to improve quality and cost.
  • Originate and maintain written technical descriptions of processes and procedures comprehensive in scope and understandable by the audience.
  • Represent engineering for Material Review Board concerning material dispositions.
  • Represent Engineering in cross functional teams as assigned.
  • Maintain compliance to procedures and regulatory requirements.
  • Understand and follow safety policies and practices, attend safety training and wear PPE as required.
  • Prepares Engineering Change Orders for processes and components.
  • Performs Corrective and Preventative Action tasks.
  • Reliable, consistent and punctual attendance is an essential function of the job
  • Other Duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Over three years’ experience in the engineering/manufacturing environment for medical devices
  • Strong drive to learn, share and teach
  • Understanding of and experience with mechanical equipment
  • FDA, cGMP principles and practices, (ISO 9001, ISO 13485)
  • In-depth understanding of one or more manufacturing processes is a plus
  • Familiarity with Pro-E / CREO and or SolidWorks is preferred
  • Strong computer skills associated with Microsoft software
  • Ability to interpret technical drawing, blueprints, specification and illustrations
  • Must be able to read, write and speak fluent English
  • Excellent reading, writing, communication, and organizational skills
  • Maintains performance with changing priorities under minimal supervision
  • Possess strong team collaboration skills
  • Must be able to make clear and accurate decisions
  • Strong desire to learn and apply new technology

WORKING ENVIRONMENT

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Production Supervisor - 2nd Shift

Summary:

This position is primarily responsible to direct the development and implementation of activities in production area(s) to meet production goals, quality, and cost objectives. Plan, organize and schedule production activities to meet customer demands. Provide direction, leadership, and motivation to production personnel, including training and assistance with adhering to the quality system.

Responsibilities:

  • Provide leadership and direction across the associated shift ensuring proper levels of production and quality are met.
  • Responsible for ensuring conformance to all company policies, procedures, and work instructions.
  • Plan, organize, and schedule production activities (including personnel and equipment) to meet schedules for both standard production and development projects.
  • Coordinate hiring and training of new employees along with recording the status of the training.
  • Coordinate job rotations and cross training.
  • Prepare and submit performance reports along with determining what increases employees will receive based on performance.
  • Regularly communicate team performance to employees and management.
  • Preemptively coordinate material and system requirements to ensure minimum amount of downtime and recommend measures to improve production methods, yields, and the quality of product
  • Maintain production goals and deadlines. Preemptively coordinate material and system requirements to ensure minimum amount of downtime and recommend measures to improve production methods, yields, and the quality of product.
  • Manage production personnel, including planning personnel needs, participating in the hiring process, and managing performance.
  • Conduct daily team meetings for proper communication and development of production team.
  • Develop in depth knowledge of production processes and associated equipment, including laser workstations and CNC motion control programs.  Troubleshoot manufacturing issues as part of maintaining production schedule and developing self-reliance among production technicians.
  • Contribute to development, maintenance, and follow up of production metrics.
  • Plan, implement, and maintain the production environment with focus on safety, cleanliness, and organization.
  • Participate on and lead teams that improve safety, quality, and reliability in the production area, as well as teams that support cost saving and team building initiatives (QDC).
  • Plan and implement technical skills training for production personnel, including generic and product specific skills. Act as trainer when necessary.
  • Understand the requirements of and ensure compliance with the preventative maintenance program.
  • Complies with company, quality and safety standards, policies, and procedures.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Be able to read, write and speak fluent English.
  • Associates degree or equivalent experience in a related field
  • Minimum 3+ year’s supervisory experience in a manufacturing environment, preferably in a medical device manufacturing environment and in leadership role
  • Computer literate (MS Office Suite, Syteline)
  • Understanding and implementation of Lean Manufacturing and Six Sigma for process improvement and problem solving.
  • Strong knowledge of ERP/MRP business functions.
  • Able to prioritize and manage multiple responsibilities.
  • Must be able to read blueprints and interpret technical specifications and illustrations.
  • Experience in technical report writing and verbal communication skills.

WORKING ENVIRONMENT

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

General Referral Application

General Referral

Don’t see a position that fits your background and experience? We are always accepting applications and resumes that we keep on file. If we open a new position that better fits your background and experience we can review your general referral application.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com