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

HR Manager

Summary:

This position is responsible for developing policy, directing and coordinating human resources activities, such as: employment, compensation, labor relations, benefits, training, and employee services by performing the following duties.

Responsibilities:

  • Analyzes wage and salary reports and data to determine competitive compensation plan.
  • Writes directives advising department managers of Company policy regarding equal employment opportunities, compensation, and employee benefits.
  • Consults legal counsel to ensure that policies comply with federal and state law.
  • Develops and maintains a human resources system that meets top management information needs.
  • Oversees the analysis, maintenance, and communication of records required by law or local governing bodies, or other departments in the organization.
  • Identifies legal requirements and government reporting regulations affecting human resources functions and ensures policies, procedures, and reporting are in compliance. Studies legislation, arbitration decisions, and collective bargaining contracts to assess industry trends.
  • Writes and delivers presentations to corporate officers or government officials regarding human resources policies and practices.
  • Recruits, interviews, tests, and selects employees to fill vacant positions.
  • Plans and conducts new employee orientation to foster positive attitude toward Company goals.
  • Keeps records of benefits plans participation such as insurance and pension plan, personnel transactions such as hires, promotions, transfers, performance reviews, and terminations, and employee statistics for government reporting.
  • Coordinates management training in interviewing, hiring, terminations, promotions, performance review, safety, and sexual harassment.
  • Advises management in appropriate resolution of employee relations issues.
  • Responds to inquiries regarding policies, procedures, and programs.
  • Administers performance review program to ensure effectiveness, compliance, and equity within organization. Administers salary administration program to ensure compliance and equity within organization.
  • Administers benefits programs such as life, health, and dental insurance, pension plans, vacation, sick leave, leave of absence, and employee assistance.
  • Investigates accidents and prepares reports for insurance carrier.
  • Conducts wage surveys within labor market to determine competitive wage rate.
  • Prepares budget of human resources operations.
  • Prepares employee separation notices and related documentation, and conducts exit interviews to determine reasons behind separations.
  • Prepares reports and recommends procedures to reduce absenteeism and turnover.
  • Represents organization at personnel-related hearings and investigations.
  • Contracts with outside suppliers to provide employee services, such as temporary employees, search firms, or relocation services.
  • 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.
  • 7-10 years’ prior human resources management experience.
  • Ability to read, analyze, and interpret the most complex documents.
  • Capability to respond effectively to the most sensitive inquiries or complaints.
  • Ability to write speeches and articles using original or innovative techniques or style.
  • Capacity to make effective and persuasive speeches and presentations on controversial or complex topics to top management.

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 encounters while performing the essential functions of this position.

 APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Director of Program Management

Summary:

The Director, Program Management leads the design and development program pipeline across Cirtec’s entire portfolio. The person in this role leads a program management organization chartered to drive multi-functional teams to deliver customer expectations compliant with cGMP requirements within cost and schedule constraints. He/She is responsible for developing, improving and measuring the business processes associated with the Product Development Process. In partnership with the cross-fuctional leadership team, he/she sets direction, drives change, and executes on deliverables that meet the short-term tactical needs and longer term ambition of the site and Cirtec as a whole.

Responsibilities:

  • Manages and develops a team of program managers with oversight of complex, Class III device programs.
  • Assures the development of multi-level project planning to achieve short and long-term business objectives.
  • Develops, tracks and reports on all key product development and technology development programs.
  • Keeps executive management team informed of design/development progress and issues.
  • Develops functional departmental budgets and coordinates cross-functional program budgets.
  • Develops and communicates key performance indicators (cost/schedule/technical/quality) for programs.
  • Provides design/development teams with appropriate resources to perform assigned tasks.
  • Interfaces with appropriate internal and external resources to ensure intellectual property is protected.
  • Interfaces with appropriate internal and external resources (regulatory, customers, etc.) to ensure development programs meet regulatory and customer requirements.
  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
  • Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

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:

  • Four-year degree in a technical field (e.g. biomedical, mechanical, software). Advanced technical or business degree a plus.
  • Minimum of ten (10) years’ experience in Class-3 medical device development and/or other regulated industry.
  • Minimum of 5 years of formal program management experience, PMP certification a plus.
  • Experience working in a broader enterprise/cross division matrixed business unit model preferred.
  • Demonstrated strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.
  • Ability to work effectively within a team in a fast-paced changing environment.
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
  • Multi-tasks, prioritizes and meets deadlines in timely manner.
  • Strong organizational, planning, and follow-up skills and ability to hold others accountable.
  • Ability to travel up to approximately 25%.
  • PMBOK tools and techniques: Demonstrated Project Planning, Scope/Time/Cost/resource Management and Project Communication.

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 encounters while performing the essential functions of this position

 APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Quality Documentation Retention Specialist

Summary:

The Quality Documentation Retention Specialist will be responsible for reviewing Quality records for accuracy, ensuring that mistakes are correctly amended, scanning all device history records, and delivering all Quality records to the Quality Documentation Assistant for storage.

Responsibilities:

  • The Documentation Retention Specialist will review production travelers for accuracy, ensuring all fields are completed, that data is accurate, and ensuring that mistakes are correctly amended.
  • The Documentation Retention Specialist will be responsible for scanning all device history records to the designated locations after all operations are completed.
  • Deliver all completed and scanned device history records to the Quality Documentation Assistant for data entry and storage.
  • Other tasks as assigned.

Qualifications:

  • Familiar with Good Documentation Practices
  • Self-starter, ability to handle multiple priorities, and detail oriented
  • Excellent written and verbal communication skills
  • Working knowledge of Microsoft Office
  • Bachelor or Associates degree preferred; High school diploma or GED required
  • Two years of related experience

 APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Materials Management Supervisor

Summary:

The Materials Management Supervisor is responsible for supervision and execution of shipping, receiving, inventory management and material handling across the manufacturing facility. Under general supervision, he/she will manage spikes in demand with minimal impact to the business. He/she will be responsible for business processes associated with processing and distribution of materials within the factory. Qualified candidates will have experience in lean fundamentals, material handling, and KPI management and management of hourly labor.

Responsibilities:

  • Manage Supply Chain Processes & Procedures related to receiving, shipping and material management within the factory.
  • Performance management and efficient deployment of hourly labor in execution of material management responsibilities.
  • Monitor and report KPIs, propose improvements and execute activities to improve performance.
  • Establish and manage cycle count programs for the factory.
  • Interface with Manufacturing Engineering, Quality, Production and others to support problem resolution to minimize impact to the production schedule.
  • Ensure sufficient capacity for material management execution based on expected forecasts.
  • Maintain accurate material lead times to insure uninterrupted production.
  • Ensure adherence to agreed upon budgets for assigned areas.
  • Ensure that business is conducted with integrity and in compliance with all company and regulatory agency requirement, procedures and processes.
  • Complete all other assigned tasks as necessary to support achievement of Supply Chain goals.

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 5 – 10 years Supply Chain Management experience in medical device or FDA regulated industry.
  • Must be able to read, write and speak fluent English.
  • CMP/APICS certification a plus.
  • Solid understanding and previous experience with an Enterprise Resource Planning (ERP) System.
  • Strong problem solving and decision-making skills
  • Strong computer skills, including the MS Office suite.
  • Familiarity with LEAN practices preferred.

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 and 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 Design Engineer

Summary:

Defines, develops and designs medical devices and related accessories. Owns efforts in developing solutions to product design, and design for manufacturability. Able to multitask and run multiple projects meeting customer commitments while anticipating customer needs. Effectively communicate to all levels of management and production personnel. Prioritize tasks based on direction given by management to ensure all project deliverables are completed successfully.

Responsibilities:

  • Responsible for product system design and ensuring that products developed meet both internal and external customer requirements.
  • Utilize design development, analysis and statistical tools, including SolidWorks, Minitab, DOE, Measurement System Analysis, Gage R & R, Process Capability, and Confidence & Tolerance interval analysis.
  • Provides regular status updates to management and or customer.
  • Provides work direction to team members that may include other engineers or technician level team members.
  • Leading and/or participating in DFMEA, PFMEA, and Risk analysis activities.
  • Performs design reviews and pre-verification assessments to ensure design outputs will be met.
  • Writes/updates part specifications, mechanical drawings, and various technical documents.

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:

  • 3-5 years of experience in the medical device industry with responsibility for materials, designs, and processes on electro-mechanical implants or external devices
  • SolidWorks experience
  • Excellent reading, writing, communication, and organizational skills
  • Experience/Expertise in experimental techniques including statistical analysis, DOE and tolerance analysis
  • A BS degree in relevant engineering discipline

 APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Coil Winding Operator

Summary:

This position is primarily responsible for maintaining simple set-ups on Coil Winding machinery and have a good working knowledge of the machines.

Responsibilities:

  • Maintain an efficiency level of at least 100%
  • Accurately completes all department paperwork including in-process, first piece and count sheets
  • Good working knowledge of blueprints
  • Ability to change materials used to produce coils
  • Be familiar with functions of the machine including tooling and programming
  • Demonstrates concern for equipment by proper use of all equipment and maintaining a clean work area
  • Demonstrate an ability to use inspection equipment as required
  • Ability to solve problems of quality and efficiency working within the team
  • Part specific procedure and machine training by the team leader is required prior to any level 1 employee operating a machine or performing an operation
  • 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:

  • 1 year of microscope experience
  • Ability to communicate effectively
  • Able to read blueprints, instructions, schematics

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

Facilities Technician

Summary:

This position is primarily responsible for ensuring all facility janitorial, coffee, soda, and other general maintenance PM’s (preventive maintenance) including maintenance schedules are up to date and equipment is maintained properly, ensuring Cirtec’s facility is at the highest level of cleanliness and safety.

Responsibilities:

  • Communicate with Supervisor about facility needs
  • Maintain all coffee & soda stations daily
  • Manage required facility and custodial documents per Cirtec’s policies
  • Perform and improve daily, weekly, monthly, quarterly, and yearly PM’s
  • Maintain safe sidewalks and building access during winter
  • Safely use chemicals in all cleaning processes
  • Communicate inventory of supplies related to janitorial and facility maintenance
  • Troubleshoot and perform plumbing and electrical small repairs as needed
  • Complete special projects such as carpet cleaning, wall cleaning, painting, ceiling tile repair, etc.
  • Promote efficiency and cost reduction
  • Provide training for the janitorial/custodial staff if necessary
  • Maintain compliance with local, state and federal laws
  • Ensure property is clean and safe inside and outside of the building
  • Promote safety daily
  • Perform general repairs and improvements
  • Perform assembly and disassembly of various items such as tables, chairs, desks, security cages, racking, etc.
  • 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-GED
  • Effective verbal and written communication and listening skills
  • Good customer service skills
  • Proficient with Microsoft Office and email
  • Ability to work with CMMA systems
  • Must be flexible to adapt to changing and varying work requirements
  • Must be able to meet deadlines while the workload level fluctuates
  • Ability to perform well under pressure
  • Self-motivated and able to work alone with minimal supervision
  • Ability to organize and prioritize
  • 2+ years janitorial and handyman background
  • Ability to use chemicals safely
  • Ability to lift 50 lbs occasionally
  • Mechanically inclined (able to perform facility and equipment repairs)
  • Ability to use hand tools/power tools
  • Ability to climb ladders, be in small spaces, and work on your hand and knees when necessary
  • Detail oriented

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 50 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 and safety glasses are required. The noise level in the work environment is usually moderate and we do provide hearing protection. 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

Assembler I

Summary:

This position is primarily responsible to perform assembly operations according to written procedures in the clean room environment meeting all quality standards. Be familiar with and follow operating requirements including GMPs (Good Manufacturing Practices) and specific customer defined requirements.

Responsibilities:

  • Perform assembly operations per written procedures meeting both quality and productivity requirements.
  • Follow verbal and written instructions of Trainers, Supervisors and Engineers.
  • Active participation in improving quality and processes.
  • Demonstrate the ability to read blueprints, use microscope and inspect all print requirements of components affected
  • Communicate effectively when problems arise or efficiencies can’t be met by yourself or other team members.
  • Understand and promote good manufacturing practices (GMPs) including all clean room related requirements.
  • Interact effectively with engineering and quality to solve problems.
  • Show self-motivation to optimize job performance on a continual basis.
  • Demonstrate concern for equipment by proper use of it.
  • Maintain a clean and orderly work area.
  • Ability to diagnose and solve problems with jobs in a 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:

  • One year minimum of microscope experience
  • Attention to detail
  • Ability to interpret written and verbal work instructions
  • Blueprint Reading

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

Contracts Manager

Summary:

Individual with the ability to provide a broad range of legal support for business operations in the medical device/manufacturing space. The successful candidate will be responsible for the coordination, preparation, negotiation, and execution of commercial contracts of CDAs, and working with counsel on development, manufacturing, and licensing agreements. The candidate will also be involved in developing company policies for the contract lifecycle, document management and retention. The successful candidate will also assist with the establishment of a contract management system and the importation of legacy contracts.

The position will interact directly with internal and external counsel, as well as company leadership. The ability to work in a high-pace, high-volume, and dynamic work environment is a must; the ideal candidate will be easy-going, approachable, flexible, and have a great sense of humor. Excellent analytical, communication, leadership, organizational, and project management skills are necessary for success in this role. Must be able to manage strong-willed clients. Knowledge of Microsoft Outlook, Word, Excel and Powerpoint is required. You will report to the General Counsel.

This position is office based in our Brooklyn Park, MN location.

Education/Qualifications:

  • Associate or Bachelor’s degree or higher; 3-5 years of experience in contract negotiation and management; Paralegal certification desired but not required.
  • Team player with excellent judgment, attention to detail, and interpersonal/communication skills.
  • Capacity to simultaneously handle a variety of complex contracts with minimal guidance.
  • Demonstrable experience taking ownership of issues and providing contract assistance.
  • Ability to prioritize and undertake mission critical tasks in a fast-paced environment.
  • Experience in medical device and/or manufacturing field.

General Attributes Needed for Success:

  • A great sense of humor
  • A collaborative and persuasive personality able to influence executives and non-executives
  • Able to effectively communicate with internal and external customers and at all levels of the organization
  • Demonstrated ability to communicate complex legal issues and solutions clearly and succinctly
  • Highly detail-oriented
  • Self-starter capable of identifying challenges, responding to issues, and implementing effective solutions with limited supervision
  • Exceptional judgment in identifying risks, developing solutions, and implementing successful strategies to mitigate risk while achieving the organization’s commercial goals.
  • Practical, creative, results-oriented thinking style with demonstrated ability to understand issues from both the legal and business perspective
  • Growth-minded mentality with demonstrated ability to rapidly absorb and internalize new information and processes
APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Senior Mechanical Designer

Summary:

This position is primarily responsible for developing and designing medical devices, tooling and fixtures from concepts and sketches utilizing SolidWorks while complying with industry drafting standards. Activities completed in this position must be implemented in accordance with Good Manufacturing Practices, Good Documentation Practices, ISO and FDA requirements.

Responsibilities:

  • Generate 3D models and Engineering drawings
  • Concept design
  • Design detailed tooling, gage, and fixture engineering drawings independently and with input from the subject matter expert or engineer
  • Review engineering drawings to ensure adherence to specifications and standards
  • Design reviews
  • Manage workload to support various departments
  • Work effectively with other departments to resolve drawing discrepancies
  • Work with product development teams to ensure compliance when transferring documents to production release
  • Maintain strict adherence for multiple CAD file relationships, models, assemblies, libraries and symbols
  • Maintain compliance to procedures and regulatory requirements
  • Maintain CAD database support in multi user environment
  • 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, GDP principles and practices, (ISO 9001, ISO 13485)
  • 5 plus years’ experience in the engineering/manufacturing environment (Machining, Finishing, and assembly) for medical devices related to product and tool design
  • Proficiency with Solidworks required
  • 3D Printing knowledge
  • Understanding of mold design
  • Understanding of toolmaking/machining practices
  • Solid working knowledge of dimensioning and Geometric tolerances, GD&T
  • Computer skills associated with Microsoft software
  • 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 team collaboration skills
  • Must be able to make clear and accurate decisions
  • Strong mechanical aptitude
  • Possess degree of professionalism
  • PLM/PDM file management experience preferred
  • Associates degree in an Engineering discipline or related field

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/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

Machine Maintenance Technician

Summary:

This position is responsible for preventative maintenance on all machines in the production areas ensuring optimum performance.

Responsibilities:

  • Maintain preventative operation of all production equipment
  • Perform preventative maintenance as instructed by the Computer Machine Maintenance System (CMMS)
  • Complete work orders in the specified time, directed by the CMMS
  • Perform projects and other duties in a similar nature and complexity, as assigned by Manager
  • Keep work area clean and presentable while performing assigned tasks
  • Must be able to use basic hand and power tools
  • Work in a safe manner
  • Safely use chemicals while performing assigned tasks
  • Lock/Out Tag Out of equipment when necessary, or instructed by Manager
  • Able to work independently when performing assigned tasks
  • Accountable for work performed
  • Performing coolant tank cleaning
  • 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’ practical hands-on experience
  • Good mechanical aptitude
  • Some electronic/electrical experience
  • Some prior machine tool maintenance would be helpful
  • Must be willing to learn all aspects of machine tools, fabrication and clean room equipment

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 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.

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

Corporate VP of Quality & Regulatory

Summary:

The VP of Quality assures quality products and processes by establishing and enforcing quality standards, testing materials and product. The VP of Quality is responsible for maintaining a corporate Quality Management System and Quality team that promotes customer satisfaction and that positively impacts the financial performance of the company.

Responsibilities:

  • Manages and direct all areas of Quality
  • Provides quality assurance leadership, coaching (evaluations), mentoring, and teaching
  • Contributes to management team activities and strategic planning
  • Supports implementation and continuous improvement of processes through SPC and process control throughout entire organization
  • Provides sponsorship and acts as change facilitator for APC, FMECA, DOE and process validation
  • Generates all reporting related to cost of Quality
  • Responsible for and leads all aspects of the company’s ISO and FDA compliance
  • Represents organization as the management representative for the Quality System with the ISO and FDA audits
  • Responsible for maintaining the Quality System and all Quality procedures
  • Manages the ISO Quality System and ensures ongoing compliance
  • Maintains internal audit function
  • Manages organization’s compliance to FDA requirements by administering Corrective Action and Preventative Action (CAPA) system
  • Promotes and maintains Certified Supplier programs, including required audits
  • Ensures and administers quality training for all employees
  • Promotes company quality standards per the Quality Policy to all employees
  • Manages all areas of the Quality System and related customer communication
  • Facilitates the Material Review Board function
  • Handles customer returns and ensure CARs in a timely manner
  • Maintains proper quality planning and contract review
  • Reports internal and customer quality rating and issues to management
  • Qualifies processes, software or equipment as required
  • Facilitates improvement in quality tools and techniques including SPC and provides quality and statistical expertise to teams
  • Provides process improvement knowledge, methods and conceptual expertise to teams
  • Completes supplier surveys
  • Facilitates Quality Agreements
  • Notifies customers of process changes as necessary
  • Promotes organization to customers around the world and fosters customer/industry relations
  • Manages and reports customer satisfaction surveys
  • Other responsibilities and 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 7 years of experience in a medical device environment, preferably as a Quality Manager, with supervisory and decision making responsibilities
  • Bachelor of Science, preferably in an engineering discipline (Master’s Degree preferred)
  • Quality/Regulatory Certifications (preferred)
  • Previous employment in a decision making position in the field of Quality Control/Assurance and Regulatory activities
  • Knowledge and experience with external standards: ISO 9001, ISO 13485, and 21 CFR 820 (FDA cGMP/QSR), especially pertaining to product development, manufacturing, supplier management, quality control and customer complaints
  • Experience in effectively managing audits by customers and regulatory agencies
  • Must be able to implement quality programs, interpret the collected data, and present the data to management to drive continuous improvement
  • Ability to prepare protocols, reports, SOPs and other documents
  • Experience in Class II and Class III Medical Device industry
  • Strong verbal and written communication skills; ability to present complex data to internal and external contacts
  • Experience in coaching and developing subordinates, utilizing performance management tools and disciplines, while increasing employee engagement and retention
APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Design & Development Quality Engineer

Summary:

Essential responsibilities of the Design & Development Quality Engineer are activities associated with Design Control and Design Quality Assurance during the Product Design and Development Process. Additional general Quality duties and responsibilities include, but are not limited to: statistical qualitative and quantitative data analysis; returned product complaint investigation and analysis; Manufacturing Engineering support; Training and Education; Metrology and Gage R&R; and other Quality Management Systems functions as this role is expected to provide input and contribute on Quality System improvement strategies and approach.

Reporting Relationships:

  • The Design & Development Quality Engineer position reports up to the Principal Engineer / Quality Engineering Manager / Site Leader of Quality.
  • This position may have direct-reporting and/or supervisory responsibilities for daily activities of Contract Personnel and/or Quality Technicians (responsibility dependent on geographic organizational structure).

Responsibilities:

Product / Process Development activities:

  • Author and execute Quality Plans for Product Design and Development projects.
  • Initiate and/or consult in the development and/or update of Risk Management FMEA and Hazard Analysis documentation in cooperation with cross-functional engineering teams per project requirements.
  • Develop and perform operational and process qualifications for customer manufacturing processes in cooperation with cross-functional engineering teams per project requirements.
  • Provide direction in implementing Incoming Inspection, First Article Inspection, In-Process and Final Product Inspection plans.
  • Develop and justify appropriate sampling plans with characterization of test/inspection methods and acceptance criteria.
  • Author, review and/or approve documentation for Design Control activities for Design and Project Phase Reviews as well as Product Verification testing in cooperation with cross-functional engineering teams per project requirements.
  • Assist in qualification activities associated with supplier/vendor design characterization requirements for projects, to include audits and assessments.
  • Represent Quality Engineering in design and phase reviews throughout the product development process.

Ensure FDA and ISO Compliance in all areas:

  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues, including CAPA’s, CCR’s and NMR’s.
  • Provide statistical data / trending analysis on CAPA, NMR and other quality metrics.
  • Provide quality oversight on maintaining ISO Class 7 clean rooms including review and trending of the testing and monitoring reports
  • Strong verbal and written communication skills, including technical report writing
  • Ability to work with a wide variety of functional areas, including R&D, Manufacturing, and QA, as required accomplishing results with minimal guidance.
  • Other duties as assigned.

Qualifications:

Education:

  • Bachelor of Science Degree in Engineering, Manufacturing Design, Biomedical or related Technical discipline.
  • Advanced Degree preferred.

Technical: 

  • Minimum of 3 years of experience in a regulated manufacturing environment.
  • Experience with metal stamping processes.
  • Experience with medical device design and manufacturing requirements, specifically in the areas of design control and design transfer for manufacturing/production.
  • Demonstrable knowledge and experience with Manufacturing Process tools/methodologies including: Process Change Assessment, Risk Management (Hazard Analysis), Process FMEA, Statistical Analysis, Process Qualification, Gauge R&R, and Inspection/Test Method Validation.
  • Design Controls / DFx / DFm / DFr knowledge and experience preferred.
  • Knowledge and experience with external standards: ISO 9001, ISO 13485, and 21 CFR 820 (FDA cGMP/QSR), EU MDD, TGA, MHLW, especially pertaining to product development, design controls, good manufacturing practices, supplier auditing & management, quality control (GD&T, MRB, etc.), CAPAs and customer complaints.

Skills: 

  • Strong verbal and written English language communication skills, including experience in technical protocol and report writing.
  • Ability to work with cross-functional groups and teams including R&D, Manufacturing, and QA as required working collaboratively to accomplish results with minimal guidance.
  • “Hands-on” self-starter with ability to work both independently and as part of a team.

Training: 

  • Training or equivalent work experience with general computer use and software applications (e.g. Microsoft Word, Excel, Power Point, Visio and Access).
  • Experience with statistical software tools (i.e. Minitab) experience preferred.
  • Must be able to drive and implement quality initiatives, interpret collected data, and present the data to multiple levels of management as part of continuous improvement / continuation engineering activities.

Expectations:

  • Interaction: Capability to present information in public speaking forums including, but not limited to, the ability to meet with external agencies and clients/customers, as required/desired.
  • Initiative: Capability to function independently without supervision.
  • Leadership: Capability to effectively lead and initiate discussions and meetings with Sr. Management staff and team.
  • Analytical Problem Solving: Capability to employ systematic and logical approached to problem-solving and develop and execute plans to take action/make adjustments.
  • Team Player: Must be able to work and thrive in a team environment.
  • Effective Communication: Excellent verbal and written communication skills and the capability to interface and communicate ideas, concepts, challenges and solutions with staff, cross-functional peers and personnel effectively.
APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Quality Engineer

Summary:

Essential responsibilities of the Quality Engineer are activities associated with Quality support of continuous improvement and continuation engineering for sustaining manufacturing operations. Additional general Quality duties and responsibilities include, but are not limited to: statistical qualitative and quantitative data analysis; returned product complaint investigation and analysis; Manufacturing Engineering support; Training and Education; Metrology and Gage R&R; and other Quality Management Systems functions as this role is expected to provide input and contribute on Quality System improvement strategies and approach.

Reporting Relationships:

  • The Quality Engineer position reports up to the Quality Engineering Manager or Site Leader of Quality.
  • This position may have direct-reporting and/or supervisory responsibilities for daily activities of Contract Personnel and/or Quality Technicians (responsibility dependent on geographic organizational structure).

Responsibilities:

Product / Process Development activities:

  • Author and execute Quality Plans for product / process improvement projects / programs.
  • Initiate and/or consult in the update of Process / Product Risk Management FMEA and Hazard Analysis documentation in cooperation with cross-functional engineering teams.
  • Develop and perform operational and process qualifications for customer manufacturing processes in cooperation with cross-functional engineering teams per project requirements.
  • Provide direction in implementing Incoming Inspection, First Article Inspection, In-Process and Final Product Inspection plans.
  • Develop and justify appropriate sampling plans with characterization of test/inspection methods and acceptance criteria.
  • Author, review and/or approve documentation for Process and Design Change activities as well as Validation / Verification oversight and/or test execution in cooperation with cross-functional engineering teams per project requirements.
  • Assist in qualification activities associated with supplier/vendor process characterization requirements for projects, to include audits and assessments.
  • Represent Quality Engineering in program / project phase reviews throughout the development of manufacturing processes and process improvement initiatives.

Ensure FDA and ISO Compliance in all areas:

  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues, including CAPA’s, CCR’s and NMR’s.
  • Provide statistical data / trending analysis on CAPA, NMR and other quality metrics.
  • Provide quality oversight on maintaining ISO Class 7 clean rooms including review and trending of the testing and monitoring reports
  • Strong verbal and written communication skills, including technical report writing
  • Ability to work with a wide variety of functional areas, including R&D, Manufacturing, and QA, as required accomplishing results with minimal guidance.
  • Other duties as assigned.

Qualifications:

Education:

  • Bachelor of Science Degree in Engineering, Manufacturing Design, Biomedical or related Technical discipline.
  • Advanced Degree preferred.

Technical: 

  • Minimum of 3 years of experience in a regulated manufacturing environment.
  • Experience with metal stamping processes.
  • Experience with medical device design and manufacturing requirements, specifically in the areas of design control and design transfer for manufacturing/production.
  • Demonstrable knowledge and experience with Manufacturing Process tools/methodologies including: Process Change Assessment, Risk Management (Hazard Analysis), Process FMEA, Statistical Analysis, Process Qualification, Gauge R&R, and Inspection/Test Method Validation.
  • Design Controls / DFx / DFm / DFr knowledge and experience preferred.
  • Knowledge and experience with external standards: ISO 9001, ISO 13485, and 21 CFR 820 (FDA cGMP/QSR), EU MDD, TGA, MHLW, especially pertaining to product development, design controls, good manufacturing practices, supplier auditing & management, quality control (GD&T, MRB, etc.), CAPAs and customer complaints.

Skills: 

  • Strong verbal and written English language communication skills, including experience in technical protocol and report writing.
  • Ability to work with cross-functional groups and teams including R&D, Manufacturing, and QA as required working collaboratively to accomplish results with minimal guidance.
  • “Hands-on” self-starter with ability to work both independently and as part of a team.

Training: 

  • Training or equivalent work experience with general computer use and software applications (e.g. Microsoft Word, Excel, Power Point, Visio and Access).
  • Experience with statistical software tools (i.e. Minitab) experience preferred.
  • Must be able to drive and implement quality initiatives, interpret collected data, and present the data to multiple levels of management as part of continuous improvement / continuation engineering activities.

Expectations:

  • Interaction: Capability to present information in public speaking forums including, but not limited to, the ability to meet with external agencies and clients/customers, as required/desired.
  • Initiative: Capability to function independently without supervision.
  • Leadership: Capability to effectively lead and initiate discussions and meetings with Sr. Management staff and team.
  • Analytical Problem Solving: Capability to employ systematic and logical approached to problem-solving and develop and execute plans to take action/make adjustments.
  • Team Player: Must be able to work and thrive in a team environment.
  • Effective Communication: Excellent verbal and written communication skills and the capability to interface and communicate ideas, concepts, challenges and solutions with staff, cross-functional peers and personnel effectively.
APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Director of Supply Chain & Strategic Sourcing

Summary:

The Director, Supply Chain develops the Supply Chain Management strategy and builds the processes which ensure the organization’s readiness to meet company objectives. The person in this role leads a multi-functional team to provide compliance with cGMP requirements and create stability in planning and adherence to schedule in a service oriented environment where flexibility and responsiveness towards customers as well as security of supply / delivery performance are crucial differentiators. In addition, the Director, Supply Chain will sit on the site’s leadership team and interact with the other directors, site General Manager and senior corporate leaders to set direction, drive change, and execute on deliverables that meet the short term tactical needs and longer term ambition of the site and Cirtec as a whole.

Responsibilities:

  • Develop the Supply Chain Management strategy and build the processes which ensure the organization’s readiness to meet company objectives.
  • Build and maintain all Supply Chain Management supporting systems. Manage the Demand and Supply Planning group.
  • Responsible for enhancing and executing integrated Sales and Operations Plans (operational and tactical level) processes including maintaining the capacity models.
  • Oversight of customer service processes; warehouse operations and distribution; the management and optimization of procurement activities; and management and optimization of packaging systems engineering activities.
  • Manage and optimize processes for forecasting and invoicing customers.
  • Leadership of people to implement change, understand consequences and obtain commitment through coaching, training and clear objective setting to meet the site’s short term needs and long term ambition.
  • Develop members of the department to be key leaders within the organization.
  • Build and sustain employee engagement by creating a culture of efficient execution and an environment in which individuals and teams can excel and continuously improve.
  • Other 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:

  • BS/BA in a related field required (and MBA preferred).
  • 8-10+ years relevant manufacturing experience required; pharmaceutical experience is a plus.
  • Solid knowledge of Supply Chain Management concepts and processes.
  • People management/development skills required.
  • Must be able to handle ambiguity.
  • Must be able to interact with and influence the most senior levels of the organization.
  • Change management skills important.
  • Demonstrated business acumen (i.e., ability to understand key aspects of the company’s business strategy).
  • Collaborative; encourages cross-functional cooperation and builds strong working relationships between the supply chain and operating teams.
APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Project Manager

Summary:

This position is primarily responsible for executing the project plan and managing the project initiative to established budget and timeline. Coordinate the design, development, documentation, and validation of complex new and modified customer products.

Responsibilities:

  • Organize a project plan for complex projects to satisfy milestones and deadlines with required actions. Track and communicate project status, plans, issues, timelines, action items, and budgets internally and externally. Serve as principal contact with clients. Coordinate and direct site visits, conference calls, and day-to-day customer communication.
  • Coordinate development, validation and documentation of products and expansion of existing products, including defining requirements, timelines, and deliverables.
  • Proactively monitor the performance of assigned projects to budget and schedule to identify trends or project challenges that may impact budget and timeline. Recommend and implement corrective actions.
  • Oversee the process of preparing modified products ensuring compliance to internal and client requirements for project completion or testing and manufacturing transfer.
  • Author planning documents as required to support assigned projects.
  • Contribute to quality, design, and development activities or act as backup to engineers on assigned projects as required.
  • Assist business development with definition of project scope, timeline, and budget to support preparation of proposals, quotations, and change orders for clients.
  • Manage resources assigned to the project team to meet project goals/milestones. Work with management to ensure project has proper resources assigned.
  • Manage site transfers and ensure all validations are completed with operational success
  • Manage more than more transfer internal/external
  • Manage transfers outside the US and working with other sites

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:

  • Willingness to travel, if required.
  • Required to 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 with 5 years of applicable experience or equivalent.
  • Minimum 3 years in project engineering. Demonstrated ability to lead projects from early stage development to production.
  • Minimum 3 years in project transfers.
  • Minimum 7 years’ experience in an engineering/manufacturing environment with a mix of mechanical design, tool design and manufacturing process experience.
  • 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.

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 encounters while performing the essential functions of this position.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Tool Maker

Summary:

This position is primarily responsible for providing tool room support of CNC Programmer / Tool Making. Fabricate metal stamping dies. Machine jigs, fixtures and prototype tooling from sketches, Cad drawings and verbal information. Maintain and update Cam software and provide organization, cleanliness and general maintenance to all shop equipment as necessary.

Responsibilities:

  • Cam Programming experience in tool room environment utilizing Master Cam and Solid Works.
  • Strong 3 axis CNC machining background with experience in tight tolerance and hard milling.
  • Select proper tooling, edit programs and adjust speeds and feeds to optimize and achieve production plans.
  • Manufacture tools, jigs and fixtures including prototype development.
  • Refurbish components for in house tools, jigs and fixtures.
  • Recommend and specify upgrades on shop equipment as required.
  • Assist the engineers in the conceptualization of new fixtures.
  • 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 read, write and speak fluent English.
  • Two plus years work experience.
  • Must be familiar with and be able to set up, operate and maintain the following equipment: machining center, mill, lathe, surface grinder, cut-off saw, inspection devices and related equipment.
  • Must be able to interpret technical drawings, blue prints, specifications and illustrations.
APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Sr. Calibration Technician

Summary:

The 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.

Reporting Relationships:

  • This position may report to a Supervisor or Quality Manager at the discretion of the Site Leader of Quality
  • This position will not have direct-reporting and/or supervisory responsibilities

Responsibilities:

This position is 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 and Maintenance
  • Inspection/Test Equipment Selection and Qualification (Metrology and Gage R&R)
  • Inspection/Test Equipment Identification and Control
  • Inspection/Test Method Planning Development
  • Gauge & Equipment procurement, planning & scheduling
  • Maintenance and continuous improvement of the Calibration System to ensure that all inspection, measurement and test equipment, including mechanical, automated, electronic inspection and test equipment, 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)
  • 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).
  • Knowledge of selection and testing methodology to define and collect data to support accuracy, reliability, and capability for purpose of measurement and test equipment qualification
  • Knowledge of Test/Inspection Method qualification and/or validation principles and processes
  • Support and reinforce Quality Best Practices and GDP/GMP behaviors and continuous improvement efforts within Cirtec Medical
  • Provide training and coaching to employees on inspection, measurement and test equipment principles, processes and methods
  • 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

Qualifications:

Required Education & Experience:

  • Associate Degree or equivalent directly transferrable work experience (Manufacturing or Engineering discipline preferred)
  • Minimum 6-8 years calibration workplace experience (Medical Device area preferred)
  • Demonstrated understanding of QSR and ISO standards for Equipment Controls

Preferred Qualifications & Experience:

  • Post-Secondary Education/Training/Certification coursework (Manufacturing or Engineering discipline preferred)
  • Quality certification(s) (e.g. ASQ CQE, CQM, 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, risk management, continuous improvement, 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
APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Sr. Engineering Manager

Summary:

This position is primarily responsible with functional supervision to the process development engineering department. Responsibilities include driving process improvement, engineering excellence, resource planning and mentoring/developing engineers.   The Engineering Manager will also spend a portion of their time as a 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.
  • 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.
  • 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:

  • 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.
  • 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 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.
  • A Bachelors’ degree in an engineering discipline or equivalent.
  • Demonstrated ability to lead engineering teams successfully from early stage development to production.
  • Minimum 7 years’ experience in an engineering/manufacturing environment.
  • 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.
  • Strong analytical skills, must be able to obtain and evaluate secondary research information.
  • Ability to learn and apply new technology.
  • Exceptional knowledge of engineering principles, technical writing, material properties, good tooling practices, and statistics.

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 encounters while performing the essential functions of this position.

 APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Director of Operations

Summary:

This position is primarily responsible for the management of all manufacturing operations and related support functions, including purchasing, production planning, production operations, shipping and receiving, kitting, facilities and equipment maintenance functions, formulating and recommending manufacturing policies and programs. Create and direct a team oriented workforce to achieve and / or exceed employee and customer satisfaction, business and profit objectives, including continuous improvement within areas of safety, reliability, cost savings, team building and personnel management. Develop and implement business plans and programs in a manner that aligns with identified objectives.

Responsibilities:

  • Development and implementation of strategic plans for efficient and cost effective manufacturing, logistics, and related operations. Manages the budgets for equipment expenditures and direct/indirect labor.
  • Provide leadership for the department, staff operational areas at appropriate levels with fully qualified individuals capable of performing duties to the required level of proficiency.
  • Create and nurture a continuous improvement program and culture focusing on Lean Manufacturing processes.
  • Ensure compliance with all FDA, ISO/13485 and other external/internal quality requirements as it relates to all products and services.
  • Work across departments to achieve company and departmental objectives and build teamwork. Specifically, work with other groups to achieve product and customer standards and requirements, communicating related information as necessary to the appropriate staff.
  • Identify areas in which process modifications could positively influence a reduction in operating cost and/or increased profit. Use of specific metrics to monitor and track performance.
  • Establishes production schedules and manpower planning, based on product requirements and material supply. Review production, inventory, equipment capacity and utilization regularly. Initiate change as deemed necessary to efficiency, on time delivery, product quality or customer satisfaction.
  • Develop and maintain a thorough understanding of clients and market to ensure that services and skills align with market and/or competition.
  • Establish and maintain a positive working relationship with clients and act as a liaison to ensure their expectations are met and any requests for information are responded to in a timely manner.
  • Provide leadership and direction to the operations and production staff. Establish performance requirements and monitors achievements. Direct multiple production shift operations.
  • Acquire a strong knowledge of the production processes and all associated equipment. Manage troubleshooting of manufacturing related issues, and identify resources and action plans to resolve these issues.
  • Review MRP / ERP system (Syteline) as to its applicability, recommending alternate systems where deficiencies are identified. Use ERP system to fullest capabilities to improve efficiency, reduce errors, etc.
  •  Responsible for directing and managing the manufacturing engineers in transitioning developmental product to sustained manufacturing phase.
  • Develop and implement Continuous Improvement projects.
  • 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 read, write, and speak fluent English.
  • Experience with a FDA Regulated Biotech Pharmaceutical, or Medical Device manufacturer with over 10 years’ experience and a minimum of 5 in a leadership role; clear understanding of best practice within human resources and team development.
  • Previous experience with manufacturing of Class II and preferably Class III medical devices.
  • Excellent verbal, listening and written communication skills, strong management skills and strong presentation and persuasion skills are also required. An MBA or advanced degree in engineering or related scientific field is a big plus.
  • Hands on experience with ERP systems, Syteline a plus.
  • Demonstrated ability to develop business, operational and financial strategies, plans and programs that foster the achievement of organizational objectives.
  • Ability to translate broad strategies into specific objectives and action plans.

 APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Machinist II

Responsibilities:

  • Must meet all of Level l Operator criteria
  • Maintain a no reject quality level.
  • Effectively resolve all problems that arise or seek assistance in a timely manner
  • Interacts effectively with engineering and quality individuals to solve problems.
  • Extensive knowledge of all phases of machining and equipment.
  • Demonstrates good decision making and problem solving.
  • Continually train co-workers to encourage individual growth within company
  • Ability to set up and run all jobs within the department.
  • Promote good morale and productivity.
  • Ability to increase production and streamline set-ups for optimum efficiencies and quality.
  • Ability to trouble shoot quality problems by effectively utilizing process control and corrective actions.
  • Maintain a very high level of cleanliness and organization.

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:

  • On-going job training

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

Sterilization Engineer

Summary:

This position is responsible for technical execution of activities associated with projects in the global sterilization network to improve operational efficiency, ensure predictable product flow, and enable lowest total cost of ownership.

Responsibilities:

  • Lead development review and approval of sterilization validations and product adoptions.
  • Provide technical support for in-house ethylene oxide and moist heat sterilization, maintaining flow of development and commercial products.
  • Develop and optimize sterilization cycles with the intent of improving cycle times, reducing lead times, and sterilization of new products.
  • Oversee routine bioburden and environmental monitoring programs.
  • Develop Standard Operating Procedures, Manufacturing Work Instructions, Test Methods and provide on-site training to applicable technical staff.
  • Establish preventive maintenance program for sterilization, requalification, product loading, and material handling.
  • Develop and maintain knowledge of applicable industry standards for sterilization.
  • Assure compliance with Federal, State and local safety/environmental regulations.  Assist in environmental testing and reporting.
  • Other duties, and responsibilities as assigned.

Requirements:

  • BS in Engineering; Chemical, Mechanical, Biomedical or equivalent.
  • 3+ years in medical device sterility assurance, sterilization operations or testing environment.
  • In depth knowledge of industrial sterilization modalities (i.e. Ethylene Oxide and Moist Heat sterilization).
  • Expert knowledge of GMP compliance (FDA, BS/EN, ANVISA, etc.)
  • Knowledge of manufacturing and assembly processes.
  • Strong leadership skills.
  • Excellent verbal and written communication skills.
  • Verbal and written fluency in English.

Technical:

  • Previous experience with Class II Single-Use and Class III Medical devices preferred.
  • 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.
  • Experience associated with continuous improvement activities, including participation and/or facilitating Kaizen events using lean manufacturing principles.
  • The ability to understand a range of engineering functions and procedures.
  • A practical and logical approach to problem solving using lean six sigma concepts.
  • Interpersonal, presentation and communication skills.
  • Team working and people management skills.
  • The capacity to work well under pressure and take on new challenges.
  • Organizational and time and project management skills and the ability to work to tight deadlines and finite deliverables.
  • An awareness of health and safety issues associated to sterilization manufacturing environments.
  • Willingness and capability to travel, as required (estimated <5%).

Training:

  • In–house on the job training as required to meet job requirements.
  • Keep up with current industry technologies by attending training courses and conferences.

Performance:

  • Decision Making and Problem Solving: Must be able to make clear and accurate decisions.
  • Analytical Problem Solving: Must be able to use a systematic approach to solving problems.
  • Interaction: Must be able to communicate well verbally and in writing and work well in a team environment.
  • Versatility: Able to respond to changing priorities with minimum disruption. Ability to meet deadlines and manage projects across many departments. Ability to handle multiple projects and customers at any given time.
  • Initiative: Must be able to function with minimum supervision.
  • Leadership: Must be able to lead discussions, teams and meetings with customers and staff related to job role

 APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Sr. Process Engineer

Summary:

Defines, develops, designs, and validates manufacturing processes, also performs modification of existing processes for medical device assemblies and components. Works within the engineering department suggesting areas for improvements positively impacting product quality, cost and delivery.

Responsibilities:

  • Creates and improves processes pertaining to:
    • Feasibility Builds, Manufacturing, and Inspection
    • Planning and executing process characterization activities, through tools i.e. design experiments
    • Equipment selection
    • Process development and documentation
    • Component validation and verification samples and testing
    • Develops and executes IQ, OQ and PQ protocols and reports
    • Operator training
    • Process Failure Mode Effects Analysis
    • Clinical Builds
    • Process Validation
    • Assembly and Component Process flow layouts
  • Involved with manufacturing and product design teams to:
    • Facilitate and create processes
    • Implement systems to produce a quality and cost effective product
    • Improve Labor cycle times
  • Improve existing processes for boosting productivity, quality and cost
  • Assist with the preparation of proposals and quotes for customers
  • Creates process risk assessments
  • Assesses safety requirements ensuring they are part of the process for the builder, user and customer
  • Prepares Engineering Change Orders for processes, components, and Bill of materials
  • Performs and advises Corrective and Preventive Action tasks
  • Other duties as assigned

Requirements:

  • FDA cGMP principles and practices
  • Must have 3 or more years’ experience of medical device process or manufacturing engineering
  • 2 years’ experience with bonding techniques. I.E. – Adhesives, Chemical, Laser, Resistance welding
  • Familiarity with biocompatible materials
  • Exposure to Pro-E / CREO and or SolidWorks preferred
  • Strong computer skills associated with Microsoft software
  • Demonstrated ability to interpret technical drawing, blueprints, specification and illustrations
  • Possess a keen attention to detail
  • Must be able to read, write and speak fluent English
  • Excellent reading, writing, communication, and organizational skills
  • Demonstrated ability for systematic problem solving, DMAIC
  • Maintains performance with changing priorities under minimal supervision
  • Must maintain high ethical standards
  • Must be able to make clear and accurate decisions
  • Ability to learn and apply new technology
  • Must have a BS degree in relevant engineering discipline with a minimum 3 years of related engineering experience
APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Opportunities in Chandler, AZ

Sales Engineer

Summary:

This position is primarily responsible for combining technical knowledge with sales skills interacting directly with the customer and supporting the Business Development team. The customers are typically medical device OEM’s, and start-ups.

Responsibilities:

  • Field sales calls, maintains and develops existing customer relationships with regular phone calls and face-to-face meetings
  • Presents a consultative sales approach to determine the best solution for the customer
  • Assist Business Development team with technical sales as required
  • Follow up on leads that are determined to be house accounts or as assigned
  • Engages the appropriate internal team resources to assist with the sales process
  • Focus on the sale of electronic components and assemblies, from early stage design to custom manufacturing, utilizing the company’s vertical capabilities
  • Perform market research to determine potential customers, markets, and products
  • Assist engineering to develop proposals for design, development, and manufacturing
  • Assist in meeting sales team yearly sales projections
  • Develop and maintain communication with our employees and customers in a cooperative and professional manner
  • Be proactive in representing the customer to allow Cirtec to reach and maintain a high level of customer satisfaction
  • Prepare reports for management
  • Offers after-sales support
  • Willingness to travel up to 50%
  • Other duties as assigned

Requirements:

  • Advanced computer competency, with strong oral and written communication skills
  • Bachelor’s Degree in Engineering with strong technical background
  • 5+ years of medical device contract design and manufacturing experience
  • Technical selling experience with PCBA, thin film circuits and sensors, ASIC, and other electronic components
  • Knowledge of minimally invasive surgical devices, neuromodulation, cardiac rhythm management, and other medical electronics or implantable devices desired but not required
  • Experience with medical device software, firmware, and hardware development desired but not required
  • Familiar with CRM software like Salesforce

 APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Opportunities in Enfield, CT

Sr. Continuous Improvement Engineer

Summary:

The Senior Continuous Engineer is responsible for identifying and leading execution of a wide range of Continuous Improvement projects using industry best practices in Lean and Six Sigma approaches. This position leads, facilitates, executes, and manages projects to reduce waste and variation through use of Lean and Six Sigma tools and methodologies.

Responsibilities:

  • Participates in identification and planning of department goals and standardization and implementation of initiatives intended to improve quality, cost and delivery
  • Supports productivity, quality, process efficiency, space utilization, and standardization and lead time improvement efforts for existing and new product development programs
  • Supports the philosophy of the Toyota Production System through leading standardized use of Lean and Six Sigma approaches within the organization
  • Utilizes tools and methodologies including, value stream mapping, time studies, line balancing efforts, setup time reductions, process layout and flow improvement, 5S and standard work
  • Collaborates with cross functional teams as required
  • Evaluates, designs and implements new layouts: including storage rack, conveyor, automation, and other material handling solutions for facilities
  • Leads facility kaizen and productivity projects; ensuring projects are done according to budget and timeline
  • May supervise and provide work direction to other engineers and technicians
  • Serves as a statistical resource to a manufacturing/research facility requires a mastery of basic to advanced statistical techniques
  • Serves as an engaging and collaborative teacher providing internal consulting support for use in Lean & Six Sigma tools and data mining and presentation
  • Seeks out continuous improvement opportunities, weights their value based on benefit, investment and risk, and prioritizes work, accordingly
  • Participates in project work to help customers and operators achieve sustainable results

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, preferably in Industrial Engineering or related field or equivalent experience; advanced degree a plus
  • 7 to 15 years in years manufacturing experience; preferably in medical device; preferably in machining and assembly of implantables
  • Six Sigma or Lean Certification (ASQ or IASSC) preferred
  • Strong analytical, problem solving and project management skills
  • Demonstrated leadership capability in team settings
  • Be adaptable to accept new changes in the field of lean manufacturing and should remain abreast with the latest developments happening in that 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; multitasks, prioritizes and meets deadlines in timely manner
  • Ability to travel to sister sites (approximately 5-10%)

 APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Quality Systems Engineer

Summary:

The position will be responsible for ensuring operational adherence and compliance to Cirtec Medical’s Quality Management System (QMS) requirements. This role will be expected to provide input on, and contribute to, development and implementation of Quality System improvement strategies and approaches.

Responsibilities:

  • Corrective/Preventative Actions (CAPA):
    • Serves as Subject Matter Expert (SME) for the CAPA system.
    • Responsible for CAPA system administration, including conducting periodic meetings, tracking individual CAPAs, and, as necessary, performing work on individual CAPAs.
  • Complaints Investigation/Returned Materials Analysis:
    • Knowledge of process(es) for investigation/analysis of returned/complaint materials.
  • Nonconforming Material (NCM) Control:
    • Knowledge of ID, traceability, and containment requirements for handling of NCM.
    • Knowledge of Material Review Board (MRB) responsibilities and handling of NCM.
  • Supplier Quality Management:
    • Support supplier/vendor Qualification activities.
    • Support Management of the Approved Supplier/Vendor Listing (ASL/AVL).
    • Manage Supplier/vendor Corrective Actions (SCAR).
  • Internal Auditing:
    • Provide Support for the system to ensure all internal audits are performed as scheduled.
    • Perform internal audits to assess compliance to FDA and ISO 13485 requirements, as well as the internal Quality System, including investigation observations/findings and reporting.
  • Documentation Control:
    • Support local Document Control (PLM) and Material Resource Planning (MRP) systems.
  • Training and Education:
    • Ensure adherence to training requirements regarding Quality Management System elements, controls, processes and procedures.
  • Preventive Maintenance, Calibration & Metrology (Gage R&R):
    • Knowledge of selection and testing methodology to define and collect data to support accuracy, reliability, and capability for purpose of measurement and test equipment.
  • Author and execute Quality Plans for the QMS and Organizational Objectives projects.
  • Support Corporate Quality Management System initiatives and continuous improvement activities.
  • Provide support for the compliance of Quality System support elements (QM ‘feeder’ systems) for the site QMS and the tracking & reporting of associated metrics, as required.
  • Ensure compliance to regulatory standards and requirements as applicable.
  • Provide quality support on maintaining ISO Class clean rooms including review and trending of the testing and monitoring reports
  • Support site customer-requested auditing activities (Customer and Regulatory Agencies).
  • Ensure compliance of all site personnel to Corporate and site-level QMS and functional training requirements.
  • 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:

  • Associate/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 2-5 years’ experience in a regulated manufacturing environment.
  • Technical training and/or experience in a related field.
  • Must be able to read, write and speak fluent English.
  • Knowledge and experience with external standards: ISO 9000/9001, ISO 13485, and 21CFR 820 (FDA cGMP/QSR).
  • Familiarity with Class II or Class III medical devices
  • 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.

 APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Business Services Manager

Summary:

This position is primarily responsible in ensuring all business service and support activities are executed in a timely and effective manner so as to support core business activities.

Responsibilities:

  • Effectively manage the financial health and well-being of sustaining programs in the Enfield CT location.
  • Work with department heads and other key stakeholders to develop proposals necessary to support these sustaining programs.
  • Provide timely, accurate quotes for delivery to Sales and Project Managers on sustaining programs.
  • Follow the quote during the steps of negotiations with the customer through completion.
  • Assist with sales pipeline management by working with key sustaining customers to obtain an accurate 12 month rolling forecast.
  • Work with Business Development and other key stakeholders to manage and drive Quarterly Business Reviews with customers.
  • Review key program metrics to ensure profitability. This includes but is not limited to evaluating actual vs. assumed scrap rates, actual vs. assumed cycle times and actual vs. assumed bill of materials.
  • Work with Business Development and Pricing Coordinator to reprice existing programs when necessary. Support customer needs internally within Cirtec Enfield to ensure high customer satisfaction rates.
  • Other responsibilities as assigned.

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 quoting design and development activities.
  • Multitasker
  • Self-motivated
  • Ability to plan and organize in ambiguous situations.
  • Exceptional communication and problem solving skills
  • Strong analytic skills
  • Critical thinker

 APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Quality Control Inspector-2nd 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.

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.
  • Other duties as assigned.

Qualifications:

  • Be able to read, write and speak fluent English.
  • High school diploma-GED.
  • Certificate/s of training related to this field of work (medical or quality assurance.
  • A minimum of 2 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.

 APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Manufacturing Technician-2nd Shift

Summary:

This position is primarily responsible for the manufacturing and assembly of sterile and non-sterile medical devices.

Responsibilities:

  • Comply with all Good Manufacturing Practices (CGMP) requirements to ensure products are consistently produced and controlled according to the Quality System.
  • Comply with all Good Documentation Practices (GDP) when completing all manufacturing or quality records.
  • Insure that all Manufacturing Instructions / Inspection Instructions are followed when building client products.
  • Maintain an orderly production line at all times while building client products.
  • Provide input related to sustaining engineering regarding tools and fixtures for use in assembly, testing and packaging as required.
  • Assist sustaining engineering and design engineering with equipment qualifications, process validations and design verification testing.
  • Comply with company safety policies and procedures.
  • 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 Degree or minimum 3 – 5 years’ experience in medical device assembly.
  • Must be able to read, write and speak fluent English.
  • Strong attention to detail.
  • Knowledge of ISO & FDA requirements.
  • Experience with LEAN manufacturing a plus.
  • Ability to provide detailed information to assist sustaining engineering in determining root cause in order to identify the appropriate corrective action.
  • Good interpersonal skills.
  • Good written 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.

 APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Sr. Process Development Engineer

Summary:

Works 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
  • Assists with preparation of proposals and quotations for clients; interfaces as needed to resolve questions in a timely manner
  • Assists in preparation and maintaining of project plans to satisfy milestones, deadlines, budgets, and medical device quality regulations with required actions. Tracks and communicates project status, plans, issues, timelines, action items, and budgets.
  • Provides guidance and direction to coworkers on areas of technical expertise
  • Troubleshoots production processes as required
  • Evaluates and selects 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
  • Other duties as assigned

Requirements:

  • Willingness to travel, if required.
  • Must maintain high ethical standard
  • Must demonstrate good organizational skills
  • Ability to train new engineering employees on project engineering activities and Cirtec policies and procedures

Educational:

  • Must be able to read, write and speak fluent English.
  • A Bachelor’s degree in an engineering discipline with 5 years of relevant experience; Associate’s degree in an engineering discipline w/10 years of relevant experience; or equivalent

Technical:

  • Experience in an engineering/manufacturing environment with a mix of mechanical design, tool design and manufacturing process experience
  • 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
APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Opportunities in Los Gatos, CA

Program Manager

Summary:

The Program Manager will be mainly responsible for managing and coordinating design and development of complex and novel medical devices.

Responsibilities:

  • Manages and coordinates design and development of complex and novel Class II & Class III mechanical and electro-mechanical medical devices such as active implants, surgical devices, clinical programmers and other related medical equipment.
  • 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, and prepares comprehensive project status reports to present to internal and external stakeholders
  • Proactively anticipates program risks and issues, and quickly 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
  • Generates and contributes to new design ideas, and establishes and maintains 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 in business development with definition of program scope, timeline, and budget to support preparation of proposals, quotations, and change orders for customers.

Qualifications:

  • Minimum BS in Biomedical or Mechanical / Electronics / Computer Engineering (Masters preferred) with at least 5 years of experience within the medical device industry
  • Minimum 2 years of experience in project or program management of medical device development programs. Experience with development of medical electronics and embedded software highly preferred.
  • Demonstrated ability to lead medical device development projects from early stage design through verification/validation, and production
  • Must possess strong understanding and working knowledge of ISO 13485 and FDA 21CFR820 based Quality Systems and Design Control, and ISO 14971 Risk Management of Medical Devices
  • Must be able to interpret technical drawings, product requirements, design specifications and relevant technical documents
  • Ability to condense and communicate complex technical ideas and project status to be understandable by 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
APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Senior Program Manager

Summary:

The Senior Program Manager will be mainly responsible for managing and coordinating design and development of complex and novel medical devices.

Responsibilities:

  • Manages and coordinates design and development of complex and novel Class II & Class III mechanical and electro-mechanical medical devices such as active implants, surgical devices, clinical programmers and other related medical equipment.
  • 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 quickly 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.
  • Generates and contributes to new design ideas, and establishes and maintains 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 in business development with definition of program scope, timeline, and budget to support preparation of proposals, quotations, and change orders for customers.
  • Mentors and provides guidance to other program manager(s) and engineers.

Qualifications:

  • Minimum BS in Biomedical or Mechanical / Electronics / Computer Engineering (Masters preferred) with at least 10 years of experience within the medical device industry.
  • Minimum 5 years of experience in project or program management of medical device development programs. Experience with development of medical electronics and embedded software highly preferred.
  • Demonstrated ability to lead medical device development projects from early stage design through verification/validation, and production.
  • Must possess strong understanding and working knowledge of ISO 13485 and FDA 21CFR820 based Quality Systems and Design Control, and ISO 14971 Risk Management of Medical Devices.
  • Must be able to interpret technical drawings, product requirements, design specifications and relevant technical documents.
  • Ability to condense and communicate complex technical ideas and project status to be understandable by 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.
APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Opportunities in Lowell, MA

Business Services Manager

Summary:

This position is primarily responsible in ensuring all business service and support activities are executed in a timely and effective manner so as to support core business activities.

Responsibilities:

  • Effectively manage the financial health and wellbeing of sustaining programs in the Lowell, MA location.
  • Work with department heads and other key stakeholders to develop proposals necessary to support these sustaining programs.
  • Provide timely, accurate quotes for delivery to Sales and Project Managers on sustaining programs.
  • Follow the quote during the steps of negotiations with the customer through completion.
  • Assist with sales pipeline management by working with key sustaining customers to obtain an accurate 12 month rolling forecast.
  • Work with Business Development and other key stakeholders to manage and drive Quarterly Business Reviews with customers.
  • Review key program metrics to ensure profitability. This includes but is not limited to evaluating actual vs. assumed scrap rates, actual vs. assumed cycle times and actual vs. assumed bill of materials.
  • Work with Business Development and Pricing Coordinator to reprice existing programs when necessary.
  • Support customer needs internally within Cirtec Lowell to ensure high customer satisfaction rates
  • Other responsibilities as assigned

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 quoting design and development activities.
  • Multitasker
  • Self-motivated
  • Ability to plan and organize in ambiguous situations.
  • Exceptional communication and problem solving skills
  • Strong analytic skills
  • Critical thinker

 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.
  • 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.
  • 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
  • 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 blue prints and interpret technical specifications and illustrations.
  • Experience in technical report writing and verbal communication skills.
  • Minimum 3+ years’ supervisory experience in a manufacturing environment, preferably in a medical device manufacturing environment and in leadership role.
APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Production Supervisor-Weekend 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.
  • 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.
  • 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
  • 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 blue prints and interpret technical specifications and illustrations.
  • Experience in technical report writing and verbal communication skills.
  • Minimum 3+ years’ supervisory experience in a manufacturing environment, preferably in a medical device manufacturing environment and in leadership role.
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 participation 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
APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Continuous Improvement Engineer

Summary:

This position is primarily responsible for identifying and leading execution of a wide range of Continuous Improvement projects using industry best practices in Lean and Six Sigma approaches. Leads, facilitates, executes, and manages projects to reduce waste and variation through use of Lean and Six Sigma tools and methodologies. Utilize his/her knowledge of COGs, gross margin, facility design, material handling equipment, labor management, staff planning and project execution to identify, 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 and standardization and implementation of initiatives intended to improve quality, cost and delivery
  • Supports productivity, quality, process efficiency, space utilization, and standardization and lead time improvement efforts for existing and new product development programs
  • Supports the philosophy of the Toyota Production System through leading standardized use of Lean and Six Sigma approaches within the organization
  • Utilizes tools and methodologies including, value stream mapping, time studies, line balancing efforts, setup time reductions, process layout and flow improvement, 5S and standard work
  • Collaborates with cross functional teams as required
  • Evaluates, designs and implements new layouts: including storage rack, conveyor, automation, and other material handling solutions for facilities
  • Leads facility kaizen and productivity projects; ensuring projects are done according to budget and timeline
  • Serves as a statistical resource to a manufacturing/research facility requires a mastery of basic to advanced statistical techniques
  • Seeks out continuous improvement opportunities, weights their value based on benefit, investment and risk, and prioritizes work, accordingly
  • Participates in project work to help customers and operators achieve sustainable results
  • 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, preferably in Industrial Engineering or related field or equivalent experience; advanced degree a plus
  • 3 to 7 years’ in manufacturing experience; preferably in medical device; preferably in machining and assembly of implantables
  • Six Sigma or Lean Certification (ASQ or IASSC) preferred
  • Strong analytical, problem solving and project management skills
  • Demonstrated leadership capability in team settings
  • Be adaptable to accept new changes in the field of lean manufacturing and should remain abreast with the latest developments happening in that 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; multitasks, prioritizes and meets deadlines in timely manner
APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Expediter

Summary:

This position is primarily responsible for communicating with vendors and shipping companies to ensure that all critical deliveries arrive at their destinations on time. Be required to report any pending delivery delays to project management, and work with shipping companies to help get deliveries to their destinations as soon as possible.

Responsibilities:

  • Contact suppliers to ensure that all dropship purchase orders were received and that deliveries will ship on time
  • Maintain constant contact with vendors and shipping companies while deliveries are in route
  • Notify project management team in a timely manner if a critical delivery is going to be late
  • Work with vendors to solve invoicing issues that could delay critical shipments
  • Deliver all purchase orders to vendors either by fax, overnight mail or email
  • 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.

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/GED required (Associate degree preferred)
  • Strong time management and organizational skills
  • Exceptional computer skills
  • Solid written and verbal communications skills
  • Handle large volume of work
  • Excellent multi tasker
  • Remaining calm in the face of problems in order to evaluate the situation and make adjustments
  • Calculating and reasoning skills to deal with weights, measurements, costs, time and other things involving numbers
APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Production Planner

Summary:

This position is primarily responsible for flow of materials for assigned product lines and labor hour adjustments. This includes ensuring that bills of material are accurate, all materials are issued to the production orders.

Responsibilities:

  • Review custom bill of materials and routings to ensure accuracy.
  • Review and plan production requirements to ensure dates are accurate and match customer sales order due dates. Confirm and transfer when needed.
  • Review and plan production orders to ensure required dates are adequate. Release orders when necessary.
  • Review production orders for completeness and know material shortages before releasing to Production. Review and coordinate short sheet with Production and Purchasing.
  • Maintain estimated material list as needed to ensure all materials are issued to the production orders in a timely fashion.
  • Request drawings for production units and assembly production packages for the various product lines.
  • Adjust labor hour clocking based on Foreman and Production Manager feedback
  • Assist in new product introduction to manufacturing.
  • Assist in the closing of production orders.
  • Other assignments as designated.

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 expertise with production planning, scheduling and expediting.
  • Strong problem solving skills.
  • Be able to handle multiple tasks –while maintaining accuracy Strong written, verbal, analytical and interpersonal skills.
  • Computer skills: MRP system experience, knowledge of Microsoft Office.
  • Associates Degree in Business Administration or equivalent combination of education and experience.
  • 3 years production planning, scheduling and expediting experience.
APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Equipment Maintenance Technician

Summary:

Responsible for performing all preventive and corrective maintenance on equipment located in the fab and plating areas. It is expected that the equipment maintenance technician works independently and is capable of being successful in a matrix organization.

Responsibilities:

  • Responsible for preventive and corrective maintenance on all fab / plating area tool sets, including component disassembly / assembly / repair
  • Responsible for identifying needed parts for repairs / preventive maintenance
  • Properly handle and store chemicals and hazardous waste
  • Maintain written logs of maintenance and repairs in our online system
  • Perform other duties as assigned by your supervisor

Requirements:

  • Minimum of 4 years’ experience in performing preventive 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 communication skills
  • Manual dexterity and visual acuity are required to perform responsibilities
  • Must be able to lift 60lbs
  • Must be willing to work some weekends, alternating coverage with other maintenance techs
  • Must be legally authorized to work in the United States
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