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

Cost Accountant

Cirtec Medical is a rapidly growing, full-service outsource partner, bringing more than three decades of expertise to every phase of the product development lifecycle for complex medical devices, including state-of-the-art product design, development, and manufacturing. We partner with our customers to bring medical devices to market quickly, predictably, and cost-effectively. If you value teamwork, client focus, accountability, and innovative thinking, Cirtec is the place for you! The Senior Cost Accountant works closely with the Operations Controller as the subject matter expert on all cost accounting activities for the company, ensuring an accurate representation of product and manufacturing costs and expenses on the company’s financial statements.

Responsibilities:

  • Identify, analyze, and report variances in product costing, job costing and production activities. Review labor and overhead application and variances.
  • Collaborate with manufacturing, supply chain, and quality leaders with efforts to reduce costs, variances, customer returns, and manufacturing scrap.
  • Establish and execute cost controls for item masters, bills of materials, work centers, and job travelers.
  • Assist our sales engineers in producing customer quotes to ensure all costs are captured and appropriate profit margins are maintained.
  • Perform monthly account reconciliations, analysis, and reporting for inventory, WIP, and variances. Also provide gross margin analysis per product line and customer.
  • Provide support for year-end and other 3rd party audits of our inventory. This will include the identification of slow-moving and obsolete inventory, and communicate recommendations for the valuation and disposition of these items.
  • Assist with the budgeting process for cost and product related valuations and estimates. Provide explanations of variances and deviations of the current budget to the actual results.
  • Support IT initiatives with system improvements, upgrades and/or conversions. Act as accounting representation in cross-functional teams to properly develop and execute cost and manufacturing transaction procedures to maximize the efficiency and use of our resources.
  •  Assist with capital expenditure requests by providing return on investment analysis as needed.
  •  Perform other related duties as assigned by management.
  • 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 accounting or related field.
  • Excellent analytical and communication skills.
  • High level skills with ERP systems, with experience in data queries and extraction.
  • Proficient use of Word, Excel, and Outlook.
  • Must be self-motivated, and the ability to work independently with minimum supervision.
APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Wire EDM Programmer

Responsibilities:

  • Produces Wire EDM programs for the Wire EDM machines and Hole Popper ensuring that programs are error free, produced timely, and user friendly
  • Inspects completed components for size, squareness, and location accuracy
  • Maintains WEDM print control through updates of programs at the end of die build and deletions of obsolete prints and programs
  • Responsible for the maintenance of the Wire EDM filing system
  • Works with the Wire EDM Director, Designer and Tool Room to maintain WEDM preparation standards
  • Provides electronic design data in the most efficient manner for design updating. Works with the Wire EDM Director and Designer
  • Troubleshoots, maintains, and corrects minor problems with the Wire EDM. Assists with the measuring and cutting of parts
  • Serves as back up to the Wire EDM Director
  • Pro-actively pursues continuing education and personal development opportunities in area of expertise
  • Follows all Company and ISO procedures. Maintains procedures as assigned. Actively participates in continuous improvement initiatives
  • Promotes a SAFE and positive work environment
  • Supports activities required to implement and maintain the Company’s strategic and departmental objectives
  • Keeps abreast of latest in technology regarding area of expertise. Makes recommendations to implement, where feasible
  • Effectively communicates with other departments, supervisors, and managers, including participation in meetings as required
  • Other duties as assigned

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

Requirements:

  • High school diploma or equivalent
  • Completion of a tool and die making apprenticeship program or a combination of four to five years of trade school, tool and die making courses and related experience or equivalent
  • Experience in Job Boss and internet skills
  • Proficient in the use and setting of variables and their interpretation and application in the programming of Wire EDM programs
  • Accepts responsibility and accounts for own actions
  • Maintains high ethical standards
  • Able to get along well with a variety of personalities and individuals
  • Able to learn and apply new technology
  • Uses thinking and reasoning to solve problems
  • Excellent customer service while following company procedures
  • Demonstrated ability for systematic problem solving
  • Identifies and resolves problems in a timely manner
  • Must be able to make clear and accurate decisions

PHYSICAL DEMANDS

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

Protective Clothing Required: PPE

WORKING ENVIRONMENT

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

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Industrial Engineer - Continuous Improvement

Operational Excellence at Cirtec Medical 

The Operational Excellence (OpEx) program at Cirtec Medical functions under the philosophy where problem-solving, teamwork, leadership and utilization of best practices result in ongoing performance improvement throughout the organization. At its core, the Operational Excellence program seeks to minimize waste and variation through Lean and Six Sigma approaches leading to improved production processes and systems that operate at high efficiency.

OpEx Mission – Our mission is to constantly improve the effectiveness of the Continuous Improvement system focused on reduction of waste and variation in all business segments and locations.

OpEx Vision – Our vision includes a culture that fully embraces continuous improvement throughout the organization and works daily to improve operational performance.

We are seeking an Industrial Engineer that will work within the Operational Excellence group focused on waste reduction and margin improvement. The selected teammate will design, develop, implement, and standardize waste reduction techniques in the business.

Summary:

The Industrial Engineering (IE) role in the Operational Excellence group is a key member of the organization. The IE 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. He/she leads, facilitates, executes, and manages team training initiatives and projects to reduce waste, cost and variation through use of Lean and Six Sigma tools and methodologies. He/she will 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 and training modules that align with the Operational Excellence team charter and organizational goals and objectives.

Responsibilities:

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

Requirements:

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

Process Engineer Technician R&D

Responsibilities:

  • Create work instruction and document them both in written and photographic format
  • Make recommendations on how to improve the quality or efficiency of a process documentation
  • Originate and maintain written technical descriptions of processes and procedures comprehensive in scope and understandable by the audience
  • Represent Engineering in cross functional teams as assigned
  • Maintain compliance to procedures and regulatory requirements
  • Understand and follow safety policies and practices, attend safety training and wear PPE as required
  • Prepares Engineering Change Orders for processes and components
  • Performs Corrective and Preventative Action tasks
  • Other Duties as assigned

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

Requirements:

  • Strong drive to learn, share and teach
  • FDA, cGMP principles and practices, (ISO 9001, ISO 13485)
  • In-depth understanding of one or more manufacturing processes is a plus
  • Strong computer skills associated with Microsoft software
  • Ability to interpret technical drawing, blueprints, specification and illustrations
  • Must be able to read, write and speak fluent English
  • Excellent reading, writing, communication, and organizational skills
  • Maintains performance with changing priorities under minimal supervision
  • Possess strong team collaboration skills
  • Must be able to make clear and accurate decisions
  • Strong desire to learn and apply new technology

PHYSICAL DEMANDS

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

Protective Clothing Required: None

WORKING ENVIRONMENT

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

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Human Resources Internship

Responsibilities:

  • Working closely with the HR Coordinator, provide effective assistance in the recruitment process including posting open positions, screening resumes, sending pre-employment assessment links, reviewing assessment results, scheduling interviews, and completing candidate reference checks.
  • Submit and track progress of employee background checks.
  • Excellent problem-solving skills are required to handle unexpected situations.
  • Assist with implementing programs to support improving the employee experience.
  • Maintain ongoing relationships with employment agencies to ensure the selection of qualified talent.
  • Excellent verbal and written communications skills.
  • Ability to work with all levels of staff.
  • Prepare offer letters, and new hire packets and assist with on-boarding process.
  • Schedule meetings with employees when eligible for benefits.
  • Other duties as assigned.

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

Requirements:

  • Excellent presentation, communication and interpersonal skills.
  • Intermediate skill level with Microsoft Excel and Word.
  • Basic level of understanding HR related legal issues and HR principles.
  • Able to exercise effective judgment, sensitivity, creativity to changing needs and situations.
  • Customer-focused attitude; high level of professionalism and discretion.
  • Enrolled in an undergraduate degree from an accredited college/university majoring in HR, Business, Communications or a closely related degree.
APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Sr. Manager, Operations Quality

Summary:

The Sr Manager, Operations Quality, leads a multi-site Quality Organization supporting the manufacture of components and assemblies used in Class III active implantable medical devices. This position sits on their assigned sites’ Senior Leadership Teams and participates in the development of strategy and execution of operational objectives to achieve defined Key Performance Indicators and financial goals. This position will also be a key member of the Global Quality Steering Committee. This position is directly responsible for Manufacturing Quality Engineering, Final QC Inspection, Receiving/Inspection, Calibration and Document Review/Certificate of Compliance Issuance functions. As the Site-Level Management Representative for the Quality Management System (QMS), cross-functionally facilitates the execution of Site-level and Corporate Quality objectives and ensures adherence and compliance to QMS and Regulatory requirements.

Responsibilities:

  • Provide organizational Leadership, coaching, mentoring and guidance to all Quality personnel as well as cross-functional teams.
  • Sitting member of the site level, Senior Leadership team.
  • Drive and support Corporate Quality Management System initiatives.
  • In partnership with other Cirtec Medical Site-Quality Leaders, ensure establishment and maintenance of site registrations (e.g. ISO 13485 and FDA).
  • Lead and support Quality Systems integrations for existing and future organizational acquisitions, as directed.
  • Act as Site-level Champion for Quality Best Practices and cGMP within Cirtec Medical.
  • Provide sponsorship and act as change facilitator for SPC, Risk Management (e.g. FTA, FMEA, AHO), Design-Limit Characterization and Process Validation controls.
  • Oversee Nonconformance process and Complaint Analysis and Corrective and Preventive Action Systems, and the tracking / reporting of associated metrics.
  • Ensure functional ability to provide Quality Engineering support for Sustaining Manufacturing Process/Continuous Improvement efforts.
  • Support implementation and continuous improvement of processes through SPC and Process Control.
  • Support for Risk Management, component/material/process characterization and development, equipment/inspection qualification and process validation.
  • Support and oversee IQ, OQ and PQ activities to ensure compliance with the Quality System and customer validation strategies.
  • Support and oversee the Nonconformance Materials Review Board process.
  • Support for integration of new manufacturing capabilities, product transfers, development programs, and manufacturing customers.
  • Ensure Metrology and Calibration support for Quality and Operations inspection equipment.
  • Support and oversee the Site Customer Audits.
  • Management of the Quality Control Group to provide incoming (receiving & inspection), in-process inspection, final inspection and product release support for all manufacturing programs.
  • Partner with the Quality Systems Group to provide Documentation Control and records retention functions, Incoming/Final Inspection, Complaint Analysis, Corrective Action System and Quality Control training to Customer Focused Business Units.
  • Administration of employment practices, which may include hiring, terminating, counseling and disciplinary action for all employees. Responsible to ensure that these actions are performed in compliance with Federal and local employment laws and company policy.
  • 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.

Requirements:

  • Minimum 4-Year degree or equivalent of directly-transferrable work experience (Engineering discipline preferred).
  • Minimum 7 years of experience in a manufacturing environment, with a minimum of 4 years of Leadership/supervisory-level experience, with budget and decision-making authority/responsibilities. Regulated industry/Medical Device manufacturing experience preferred.
  • Knowledge and experience with external standards: ISO 9001, ISO 13485, and 21 CFR 820 (FDA cGMP/QSR), EU MDD, TGA, MHW, especially pertaining to product development, design controls, good manufacturing practices, supplier auditing & management, quality control (GD&T, MRB, etc.), CAPA 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.
  • Experience with the preparation, review and catalogue of SOPs, Work Instructions and other Quality Systems documents.
  • Class II and Class III Medical Device Experience.
  • Strong verbal and written communication skills. Ability to present complex data to internal and external contacts.
  • “Hands-on” self-starter with ability to work both independently and as part of a team.
  • Training or equivalent experience in computer use and software-Microsoft Word, Excel, Power Point and Access.
  • Experience in coaching and developing subordinates, utilizing performance management tools and disciplines, while increasing employee engagement and retention.
  • Experience with the preparation of Engineering protocols & reports.

PHYSICAL DEMANDS

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

Protective Clothing Required: None

WORKING ENVIRONMENT

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

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Sr. Manager, Development Quality

Responsibilities:

  • Manage the validation and design quality engineering team to provide strategic direction for Quality Assurance of Medical Devices.
  • This role works closely with hardware and software development teams to ensure quality compliant products.
  • Works with process development teams to ensure robust validation activities occur in a timely manner.
  • Oversee the review and approval of validation packages and design control related documentation generated on site such that the Quality Records comply with site and regulatory requirements.
  • Establish service level agreements to ensure timely completion and monitor teams performance in support of the sites validation, design control and on market change projects to ensure best speed to market for new/changed products.
  • Participate in the progress of failure/quality investigations and CAPAs associated with site validation and design control activities.
  • Implement and maintain site change, validation and design control activities through management of the Validation & Design Control QA group and interaction with the groups that execute such tasks.
  • Ensure that members of the department stay current on the requirements, practices, and training of the validation and design control regulations and guidance documents.
  • Ensure the expertise and material is available to be able to deploy change, validation and design control training to the site.
  • Work with Quality peers to ensure the development of consistent, best practice validation and design control policies and procedures.
  • Manage the Validation & Design QA budget to ensure spending is within agreed limits.
  • Maintain awareness of financial performance.
  • Support the development of cost-efficient business processes whilst ensuring compliance and quality requirements are met.
  • Take responsibility for financial planning of Validation & Design QA for future budget cycles.
  • 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.

Requirements:

  • Minimum 4-Year degree or equivalent of directly transferrable work experience (Engineering discipline preferred).
  • Quality and/or Regulatory certification(s) preferred (ASQ, RAPS, etc.).
  • Knowledge and experience with external standards: ISO 9001, ISO 13485, and 21 CFR 820 (FDA cGMP/QSR), EU MDR, TGA, MHW, especially pertaining to product development, design controls, good manufacturing practices, supplier auditing & management, quality control (GD&T, MRB, etc.), CAPA 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.
  • Experience with the preparation, review and catalogue of SOPs, Work Instructions and other Quality Systems documents.
  • Strong verbal and written communication skills. Ability to present complex data to internal and external contacts.
  • “Hands-on” self-starter with ability to work both independently and as part of a team.
  • Training or equivalent experience in computer use and software-Microsoft Word, Excel, Power Point and Access.
  • Experience in coaching and developing subordinates, utilizing performance management tools and disciplines, while increasing employee engagement and retention.
  • Experience with the preparation of Engineering protocols & reports.

PHYSICAL DEMANDS

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

Protective Clothing Required: None

WORKING ENVIRONMENT

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

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Process Engineer R&D

Responsibilities:

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

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

Requirements:

  • Willingness to travel, if required.
  • Must maintain high ethical standards
  • Must be able to read, write and speak fluent English.
  • A Bachelor’s degree in an engineering discipline and minimum 2 years’ appropriate work experience; or Associates degree in engineering discipline and a minimum or 4 years’ appropriate work experience; or a minimum 7 years’ relevant work experience; or equivalent.
  • Experience in an engineering/manufacturing environment with mechanical, tool design, and manufacturing processes preferred.
  • Strong computer skills, including the MS Office suite and MS Project.
  • Must be able to fully interpret technical drawings, blueprints, specifications & illustrations.
  • Strong analytical skills, must be able to obtain, evaluate, and apply secondary research information
  • Ability to learn and apply new technology.
  • Technical report preparation and formal presentation skills.

PHYSICAL DEMANDS

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

Protective Clothing Required: None

WORKING ENVIRONMENT

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

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Sr. Process Engineer - R&D

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
    • Process development and documentation
    • Clinical Builds
    • Process Validation
  • Planning and executing process characterization activities, through tools i.e. design of experiments
  • Develops and executes IQ, OQ and PQ protocols and reports
  • Operator training
  • Process Failure Mode Effects Analysis
  • Equipment selection and implementation
  • Design, develop, and implement fixturing to assist with medical device assembly
  • Qualify fixturing and manufacturing equipment
  • Assembly and 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 lowering 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, Bill of materials, routings, fixturing, etc.
  • 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
  • Familiarity with biocompatible materials
  • Exposure to 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

NPI Buyer

Responsibilities:

  • Vendor selection, qualification and development.
  • Develop strong relationships with vendors to ensure quality and delivery at best in class costs.
  • Establish and improve purchasing and planning parameters (lead times, MOQ’s, tiers and pricing).
  • Ensure vendor performance supports design requirements and production goals.
  • Review MRP to verify accurate demands and to place orders for inventory components on a timely basis.
  • Transition production ready vendors and or components or services to sustaining buyers.
  • Support project and program teams as key sourcing resource.
  • Work with Engineering and review new item masters to ensure item masters are set up correctly to maintain proper finance, inventory and purchasing guidelines.
  • Other duties as assigned.

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

Requirements:

  • Demonstrated supply chain creation, management and improvement experience.
  • A record of creating and improving vendor relationships.
  • Ability to read and interpret technical specifications, prints and requirements.
  • Minimum of 5 years’ experience in contract and or medical device manufacturing with demonstrated progressive sourcing experience.
  • Bachelor’s degree preferred.
  • Working knowledge and experience in Lean and Six Sigma methods, ERP and QMS systems, and logistics and procurement processes.
  • Experience with ISO 9001 and ISO 13485 procedures 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

Protective Clothing Required: None

WORKING ENVIRONMENT

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

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Facilities Coordinator

Summary:

Ensure that all facility systems receive the attention required for Cirtec Medical to run unimpeded. Duties including maintenance schedules are up to date and machines are maintained properly, ensuring Cirtec’s facility is at the highest level of cleanliness and safety. Coordinate through a staff of skilled, semiskilled and unskilled labor, activities concerned with the operation, repair, maintenance, and construction of facilities, equipment, buildings and grounds to minimize interruption and improve efficiency. Carries out facilities systems repairs or may obtain bids for additional work from outside contractors if asked to by management.

Responsibilities:

  • Manage required facility and custodial documents per Cirtec’s policy
  • Perform and/or delegate janitorial duties to ensure the highest level of safety and cleanliness at Cirtec Medical
  • Safely use chemicals in the cleaning process
  • Maintain an inventory of supplies related to janitorial and facility maintenance
  • Perform plumbing and electrical repairs ae needed
  • Provide supervision/leadership to the janitorial/custodial team
  • Perform and/or delegate special projects such as carpet cleaning, wall cleaning, panting, ceiling tile repair, etc.
  • Assist in overseeing and directing contracted projects to ensure adherence to specifications
  • Promote efficiency and cost reduction
  • Provide training for the janitorial/custodial staff
  • Oversee and direct contracted projects to ensure adherence to specifications
  • Maintain compliance with local, state and federal laws
  • Inspect plant facilities or review inspection reports to determine repairs, replacement and or improvements required
  • Maintain environmental records and waste reports as required
  • Inspect chemicals and ship wastes as needed
  • Create purchase requests for needed repairs and inventory
  • Be an active part of the safety team
  • Participate in Safety Committee meetings
  • Provide safety training as needed
  • Attend trainings as needed
  • Emergency on-call duties as required
  • Other duties as assigned

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

Requirements:

  • High school diploma-GED
  • Must be able to meet deadlines while the workload level fluctuates
  • Ability to life 50lbs occasionally
  • Basic computer skills
  • Effective verbal and written communication and listening skills
  • Ability to represent facilities a tactful manner
  • 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 organize and prioritize
  • Ability to use chemicals safely
  • Ability to life 50lbs occasionally
  • Mechanically inclined (able to perform facility and equipment repairs)
  • Ability to use hand tools/power tools safely and efficiently
  • Detail oriented and conduct duties and repairs in a cleanly manor
  • Electric mechanical troubleshooting skills
  • Knowledge of cleanroom environments and med device a plus

Preferred:

  • 2+ years of college training in leadership/supervision or equivalent training
  • Proficient with Microsoft Office Suite and email
  • 4 years facilities experience
  • HVAC high level systems knowledge

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

Engineer Technician

Summary:

Cirtec Medical is searching for an Engineering Technician to join its Operations team. In the fast-paced medical contract manufacturing space, this position is primarily responsible to support engineering and production. Our Engineering Technicians assist Manufacturing Engineers to document processes, update documentation, implement creative ideas or solutions to improve assembly operations, and develop tooling/fixturing as needed.

Responsibilities:

  • Actively participate in improving quality and processes for the products we manufacture
  • Understand and promote good manufacturing practices (GMPs) including all clean room related requirements
  • Assist in training employees on equipment and assembly skills
  • Interact effectively and assist engineering in improving quality and solving problems
  • Show self-motivation to optimize job performance on a continual basis
  • Maintain a clean and orderly work area
  • Ability to diagnose and solve problems with jobs in a timely manner
  • Maintain compliance to procedures and regulatory requirements
  • Understand and follow safety policies and practices, attend safety training and wear PPE as required
  • Other duties as assigned

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

Requirements:

  • 3+ years’ experience in the engineering / manufacturing environment of medical device component assembly
  • Excellent working knowledge of technical drawings, blueprints, specifications, illustrations and geometric tolerances
  • Strong problem solving and process validation experience is a plus
  • Strong computer skills including MS Office, Project, Document Control systems, Adobe Acrobat
  • Must be able to read, write and speak fluent English
  • Possess good reading, writing, communication, and organizational skills
  • Maintain performance with changing priorities under minimal supervision
  • Possess strong team collaboration skills
  • Strong desire to learn and apply new technology

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

Protective Clothing Required: None/PPE

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

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Sr. Program Manager

Summary:

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

The Senior Program Manager will be mainly responsible for managing and coordinating design and development of 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 and peripherals, surgical devices and external devices.
  • Generates and maintains detailed project plans, task lists and project risk registers that enable the team to execute activities based on well-defined prioritization.
  • Coordinates activities across different functional groups to ensure successful completion of program goals and milestones.
  • Tracks program health in terms of schedule, budget, and technical risks and issues. Prepares and presents comprehensive project status reports to internal and external stakeholders
  • Proactively anticipates program risks and issues, and carefully formulates and implements risk mitigations and corrective/preventive actions
  • Creates and maintains Design History file per internal company procedures, FDA Design Control (21 CFR 820) and ISO 13485 requirements
  • Supports project team in establishing and maintaining product requirements and test plans
  • Contributes to development, quality and risk management activities, and acts as backup to engineers and technical staff on assigned programs as required
  • Serves as the principal contact with external customers. Coordinates and directs customer meetings and visits, and day-to-day customer communication.
  • Manages internal resources to meet program goals and milestones. Works with internal management to ensure appropriate resources have been assigned.
  • Assists business development team with definition of program scope, timeline, and budget to support preparation of proposals, quotations, and change orders for customers
  • Mentors and provides guidance to other program manager(s) and engineers
  • Other duties as assigned.

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

Requirements:

  • BS in a relevant engineering or science discipline with at least 10 years of experience within the medical device industry. Experience with neuromodulation devices, Implantable Pulse Generators (IPG’s) and/or implantable lead assemblies preferred but not required.
  • Minimum 5 years of experience in project / program management of medical device development programs
  • Demonstrated ability to lead medical device development projects from early stage design through verification/validation, and transfer to production
  • Must possess strong understanding and working knowledge of ISO 13485 and FDA 21CFR820 based Quality Systems and Design Control
  • Must be able to interpret technical drawings, product requirements, design specifications and relevant technical documents
  • Ability to condense and communicate complex technical ideas, project status and risks to internal and external stakeholders
  • Must have proficiency in MS Project and other MS Office software
  • Must be able to read, write and speak fluent English, and must possess excellent communication skills, both written and oral
  • Willingness to travel, if required

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

Protective Clothing Required: None

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Program Manager

Summary:

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

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

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

Requirements:

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

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

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Design & Development Quality Engineer

Summary:

The position will be responsible for the activities associated with Quality Design & Development (QD&D) Control and Assurance during Product Development Process (PDP) activities as well as continuation design & development support for sustaining manufacturing and product distribution.

Responsibilities:

  • Design Input/ Output Characterization & Specification
  • Manufacturing Process Verification & validation Controls
  • Gage R&R, Test/Inspection Method Development & Qual.
  • Statistical Qualitative and Quantitative Data Analysis
  • Complaints Investigation/Returned Materials Analysis
  • Manufacturing Engineering support
  • Education & Training
  • ISO Class Controlled Environments
  • Metrology & Calibration (including Gage R&R)
  • Tracking and Trending Quality Objectives and Metrics,
  • Other Quality Management System Functions

This role will be expected to provide input on, and contribute to, development and implementation of Quality System improvement strategies and approaches.

Requirements:

Educational: 

  • Associate/Bachelor of Science Degree in Manufacturing, Engineering, or Technical Field, or equivalent of directly-transferable industry work experience (Engineering or Quality discipline preferred).

Technical: 

  • Minimum of 2-5 years of experience in a regulated manufacturing environment.
  • 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 Design Assurance tools/methodologies including: Design Controls, Design Change Assessment, Risk Management (Hazard Analysis), Design and Process FMEA, Statistical Analysis, Process Qualification, Gauge R&R, and Inspection/Test Method Validation.
  • 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.

Performance: 

  • 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

Opportunities in Chandler, AZ

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Opportunities in Enfield, CT

Process & Development Engineering Technician

Summary:

This position is primarily responsible to develop and improve assembly operations or in an effort to improve productivity, yield and process flow. Must provide excellent trouble shooting ability on equipment and assembly fixturing. Assist Manufacturing Engineer to develop new processes, documentation, perform experiments and develop tooling/fixturing as needed.

Responsibilities:

  • Develop processes and documentation in support of new and existing components and assemblies to include clean room assembly, machining, coiling, and laser processing support.
  • Active participation in improving quality and processes for the products we manufacture. Focusing on the clean room.
  • Excellent working knowledge of blueprint and geometric tolerances.
  • Understand and promote good manufacturing practices (GMPs) including all clean room related requirements.
  • Assist in training employees on equipment and assembly skills.
  • Interact effectively and assist engineering in improving quality and solving problems.
  • Work with tooling engineer to design fixtures for procedures developed.
  • Show self-motivation to optimize job performance on a continual basis.
  • Evaluate alternative manufacturing methods.
  • 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.

Requirements:

  • 3-5 years’ experience in a medical device clean room assembly environment. Includes, but not limited to working with different bonding agents, such as epoxies, UV adhesives & silicones. Also, familiarity with operations such as laser welding, crimping, swaging, thermoforming, annealing and general mechanical assembly.
  • Knowledge of laser operation.
  • Excellent working knowledge of blueprint and geometric tolerances.
  • Strong Problem solving and process validation experience.
  • Experience running all types of CNC machines is a plus, but not required.

PHYSICAL DEMANDS

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

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Sr. Engineer – Laser Applications

Summary:

This position is responsible for providing hands-on process development and manufacturing direction for new customer and internal laser projects; develops and establishes procedures to qualify and validate customer requirements; assist the development and manufacturing organizations in weld design, tooling, fixtures, and parameters for new and existing programs. Provides training to ensure production meets Cirtec’s quality and efficiency specifications. The ideal applicant is a hands-on person who enjoys working with laser technology and CNC programming; good work ethic and strong interpersonal skills; customer presence; excellent organization skills; and enjoys working with machinery and electronics.

Responsibilities:

  • Provide technical expertise to develop new or make improvements to existing laser equipment with a drive to increase process efficiency, product quality and cost.
  • Adheres to Cirtec’s values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.
  • Develops novel laser processing solutions to establish and improve laser processing capabilities.
  • Interface with customers, suppliers, and internal cross-functional team members to develop specifications, coordinate prototype fabrication of customer designed parts, and transition prototypes into manufactured components.
  • Project member for new design and development teams requiring laser processing.
  • Implements new laser systems, fixtures, and processes for welding.
  • Provides planning inputs and executes on project deliverables to meet established metrics.
  • Conduct process validation activities.
  • Provide cost-saving initiatives by evaluating manufacturing processes while maintaining quality standards.
  • Create and analyze prototype products.
  • Generates, reviews and approves engineering change orders.
  • Investigates root cause for product and process failures and establishes corrective actions.
  • Design experiments to provide data-based conclusion about a process or product performance.
  • Provide assistance to develop laser quotations and manufacturing procedures.
  • Understand CNC Programming to create welding and cutting programs.
  • Use SolidWorks for tool and fixture design.
  • Research and recommend capital equipment for the yearly budget.
  • Write laser processing procedures.
  • Provide process training to production operators.
  • Develop inspection procedures to verify acceptability of components.
  • Maintain and promote laser and team safety.
  • Evaluate and recommend alternative manufacturing methods.
  • 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:

  • Minimum five years Laser experience.
  • Able to program cutting and welding operations.
  • Must be able to make clear and accurate decisions.
  • Excellent reading, writing, communication, and organizational skills.
  • Develop plans for managing projects.
  • Executes and reports on verification and validation efforts.
  • Experience with ISO quality systems and World Class Manufacturing principles.
  • Strong professional communications, negotiation, and problem-solving abilities.

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. Laser Weld Technician

Summary:

This position is primarily responsible working with engineering to successfully develop and/or refine special processes to meet specific customer requirements. Along with processes development they must also assisting and/or train other technicians to effectively meet or exceed expectations for product quality and manufacturing goals. This position will serve as lead in a manufacturing environment providing guidance and support to other employees within the organization. Ensuring accuracy of all documentation related to the equipment and/or processes. This technician must also have a strong knowledge of visual and dimensional inspection techniques as well as the ability to operate associated inspection tools and equipment.

Responsibilities:

  • Has the primary function of special processing related to laser welding and associated equipment used in manufacturing medical products.
  • Understands laser dry box welding, atmosphere controls such as, O2 analyzers, gas chromatographs and vacuum chambers.
  • Can follow Engineering instructions to ensure all laser essential parameters are followed and satisfy requirements when performing qualifications.
  • Can assist an engineer in establishing weld parameters that will ensure product will maintain quality and functional requirements through its life cycle.
  • Help determine best operational practices when product is transferred to sustained manufacturing.
  • Help establish bounding essential weld parameters (input) that allow a consistent reliable welds (output).
  • Write work instructions for operating lasers and associated equipment.
  • Have the ability to set up weld equipment for any type of processing required by the customer as directed through engineering representatives.
  • Demonstrates strict adherence to all safety, GMP & quality system guidelines.
  • Assist with preparation of proposals and quotations for clients; interface as needed to resolve questions in a timely manner.
  • Ability to interface with internal groups as well as clients to serve as technical advisor.
  • Has the knowledge and ability to instruct other technicians and trainees in the interpretation of manufacturing processes and operation of equipment. Strives to impart experience-based knowledge and techniques upon other team members.
  • Work with engineering, customer representatives and manufacturing personnel to resolve technical issues.
  • Provide input/ recommendations on tooling, equipment, processing sequence, programming requirements and inspection techniques of the application.
  • Operate effectively and maintain professionalism in an environment of deadlines and high workloads and adjust schedule or work hours to meet changes in priorities.
  • Assist with developing costs, processes, and documentation for new or modified products.
  • Be able to perform the above duties with little or no supervision.
  • 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.
  • Knowledge of ERP/MRP business functions.
  • Certificate in Laser application preferred.
  • Certificate in Laser Safety Officer training preferred.
  • Knowledge of AWS requirements.
  • Ability to create motion control programs using G-code or other types of software.
  • Must be able to read blueprints and interpret technical specifications and illustrations.
  • Experience in technical report writing and verbal communication skills.
  • Minimum 3+ years’ experience in a manufacturing environment, preferably in a medical device manufacturing environment and in leadership role.

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

Process Development Engineer

Summary:

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

Responsibilities:

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

  • Willingness to travel, if required.
  • Must maintain high ethical standards
  • Must demonstrate good organizational skills.
  • Must be able to read, write and speak fluent English.
  • A Bachelors degree in an engineering discipline and minimum 2 years appropriate work experience; or Associates degree in engineering discipline and a minimum or 4 years appropriate work experience; or a minimum 7 years relevant work experience; or equivalent.
  • Experience in an engineering/manufacturing environment with mechanical, tool design, and manufacturing processes preferred.
  • Strong computer skills, including the MS Office suite and MS Project.
  • Must be able to fully interpret technical drawings, blueprints, specifications & illustrations.
  • Strong analytical skills, must be able to obtain, evaluate, and apply secondary research information
  • Ability to learn and apply new technology.
  • Technical report preparation and formal presentation skills.

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

Engineering Technician

Summary:

This position is primarily responsible to develop and improve assembly operations or in an effort to improve productivity, yield and process flow. Must provide excellent trouble shooting ability on equipment and assembly fixturing. Assist Manufacturing Engineer to develop new processes, documentation, perform experiments and develop tooling/fixturing as needed.

Responsibilities:

  • Develop processes and documentation in support of new and existing components and assemblies to include clean room assembly, machining, coiling, and laser processing support.
  • Active participation in improving quality and processes for the products we manufacture. Focusing on the clean room.
  • Excellent working knowledge of blueprint and geometric tolerances.
  • Understand and promote good manufacturing practices (GMPs) including all clean room related requirements.
  • Assist in training employees on equipment and assembly skills.
  • Interact effectively and assist engineering in improving quality and solving problems.
  • Work with tooling engineer to design fixtures for procedures developed.
  • Show self-motivation to optimize job performance on a continual basis.
  • Evaluate alternative manufacturing methods.
  • 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:

  • 3-5 years’ experience in a medical device clean room assembly environment. Includes, but not limited to working with different bonding agents, such as epoxies, UV adhesives & silicones. Also, familiarity with operations such as laser welding, crimping, swaging, thermoforming, annealing and general mechanical assembly.
  • Knowledge of laser operation.
  • Excellent working knowledge of blueprint and geometric tolerances.
  • Strong problem solving and process validation experience.
  • Experience running all types of CNC machines is a plus, but not required.

PHYSICAL DEMANDS:

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

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Sr. Process Development Engineer

Summary:

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

Responsibilities:

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

  • Willingness to travel, if required.
  • Must maintain high ethical standards
  • Must demonstrate good organizational skills.
  • Ability to train new engineering employees on project engineering activities and Cirtec policies and procedures.
  • Must be able to read, write and speak fluent English.
  • A Bachelors’ degree in an engineering discipline with 5 years of relevant experience; Associates degree in an engineering discipline w/10 years of relevant experience; or equivalent.
  • Experience in an engineering/manufacturing environment with a mix of mechanical design, tool design and manufacturing process experience.
  • 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.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Site Quality Manager

Summary:

This position will be responsible for the Leadership and management of all site-level Quality-organizational personnel and resources to ensure adherence and compliance to Cirtec Medical’s Quality Management System. The Site Quality Manager shall be the designated Site-Level Management Representative for the Quality Management System of their assigned Cirtec Medical Facility.

Responsibilities:

  • This position may have multiple direct-reporting subordinate Managers and Supervisors in addition to having direct-reporting responsibilities for daily activities of site Quality personnel (responsibility dependent on geographic organizational structure).
  • Designated Site-level Management Representative for assurance of compliance to the Cirtec Medical Quality Management System and member of the Site-Senior Management Team for the facility.
  • Drive and Support Corporate QMS initiatives and continuous improvement activities.
  • Ensure establishment and maintenance of site regulatory registrations (ISO 13485, FDA, etc.).
  • Provide organizational Quality Leadership, coaching, mentoring and guidance to all Quality personnel as well as cross-functional teams.
  • Support for integration of new manufacturing capabilities, product transfers, development programs and manufacturing customers.
  • Provide Leadership and Guidance for site-level Quality functions including Documentation Control and records retention, Complaint Handling/Returns, Corrective and Preventive Actions, Training, Supplier Quality Management, Nonconforming Material Handling, and Metrology/Calibration Control Systems.
  • Provide oversight and ensure compliance of Quality System support elements for the site QMS: Internal Auditing, Supplier Quality Management, Complaint Handling, Corrective and Preventive Actions, Nonconforming Materials Controls; and the tracking & reporting of associated metrics.
  • Act as site-level Champion for Quality Best Practices and GDP/GMP continuous improvement efforts.
  • Provide Leadership and Guidance for site-level Quality functions including incoming (Receiving & Inspection), in-process inspection, final inspection, and product release support.
  • Provide Leadership and Guidance for site-level Design and Development programs, Sustained Manufacturing and Continuous Improvement/Continuation Engineering activities and initiatives.
  • Provide Leadership and Guidance for Risk Management (Hazard Analysis and Assessment – Design & Process), Design and Limit Characterization, and Process Qualification (DV&V and PV).
  • Oversee and coordinate site auditing activities (Customer and Customer Regulatory Agencies).
  • Ensure compliance of all site personnel to Corporate and site-level QMS and training requirements.
  • Administration of employment practices, including, but is not limited to, monitoring time & attendance, hiring, terminating, counseling and disciplinary actions for all employees. Responsible to ensure these actions are performed in compliance with Federal and local laws as well as Cirtec Medical policies.
  • Must adhere to professional workplace attire, time, attendance and leave of absence policies.
  • Other duties and responsibilities as assigned.

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

Qualifications:

Required Education & Experience:

  • Minimum 4-Year degree or equivalent of directly-transferrable industry work experience (Engineering or Quality discipline preferred).
  • Minimum of 4 years Leadership/Supervisory-level experience, with budget and decision-making authority/responsibilities.
  • Minimum of 6 years’ experience in a regulated manufacturing environment.

Preferred Qualifications & Experience:

  • Advanced Post-Secondary Education/Training/Certification coursework
  • Quality certification(s) (e.g. ASQ CQT, QCI, etc.).
  • Class I, II and/or III Medical Device manufacturing experience.
  • Regulated manufacturing industry experience (e.g. Aerospace, Defense, Pharmaceutical, etc.)
  • Knowledge and experience with external standards: ISO 900/9001, ISO 13485, and 21CFR 820, EU MDR, especially pertaining to product development, design controls, good manufacturing practices, supplier qualification, auditing, quality control (GD&T, Nonconforming Materials, MRB), Corrective and Preventive Actions, and customer complaints.

Technical Requirements, Skills and Training:

  • Experience in coaching and developing subordinates, utilizing performance management tools and disciplines while increasing employee engagement and retention.
  • Strong verbal and written English language communication skills.
  • Successfully meet Cirtec Medical-specific positional/functional on-the-job training requirements.
  • Competency with 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 variety of functional areas, including R&D, Manufacturing, and QA

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

Opportunities in Los Gatos, CA

Design & Development Quality Engineer

Summary:

Cirtec is seeking a Design & Development Quality Engineer based out of our Los Gatos, CA office. The 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 of mechanical and electro-mechanical medical devices and medical electronic equipment. Additional general duties and responsibilities include, but are not limited to:

  • Statistical qualitative and quantitative data analysis
  • Returned product complaint investigation and analysis
  • Quality engineering support to sustained low volume, high value manufacturing projects
  • Manufacturing process validation
  • Supplier quality
  • Gage R&R
  • Other Quality Management Systems functions as this role is expected to provide input and contribute on Quality System improvement strategies and approach.

The Design Quality Engineer position reports up to the Quality Manager or Site Quality Leader.

Responsibilities:

  • Provide Design Quality Engineering support throughout the design, development and production of mechanical and electro-mechanical medical devices and medical electronic equipment to ensure compliance to company’s Design Control procedures and regulatory (specifically FDA 21 CFR 820 and ISO 13485) standards.
  • Author, review and/or approve technical Design Control documentation to facilitate design, development and product verification testing of medical devices and medical electronic equipment in collaboration with cross-functional mechanical, electrical and software engineering teams.
  • Author and execute Quality Plans for Product Design and Development projects
  • Represent Quality Engineering in technical design and phase end reviews
  • Develop protocols and performing Design of Experiments (DOE) and Gage R&R for processes used in manufacturing and testing of medical devices and medical electronic equipment
  • Develop inspection plans and providing quality engineering support for Incoming Inspections (including First Article Inspections), In-Process and Final Product Inspections
  • Develop sampling plans and acceptance criteria for product testing and inspection methods using appropriate statistical techniques (e.g. AQL – Acceptable Quality Level) and software tools (e.g. Minitab)
  • Lead and/or Participate in risk management activities, and developing Risk Management Plans and Reports, performing Hazards Analysis and FMEAs (Failure Mode Effects Analysis) to evaluate and ensure product safety and functionality during development and production
  • Conduct and/or support root cause investigations, develop and implement corrective and preventative actions for quality system and product related nonconformances
  • Supporting front room and back room during external audits
  • Other duties as assigned.

Qualifications:

  • Bachelor of Science in Engineering or related technical discipline with a minimum of 5 years of experience within the Medical Device
  • Experience with medical device design and manufacturing requirements, specifically in the areas of design control and design transfer to production
  • Demonstrable knowledge of and/or working experience with Design Assurance tools and methodologies including: Design Controls, Design Change Assessment, Risk Management (Hazard Analysis), Design and Process FMEA, Statistical Analysis, Process Qualification, Gage R&R, and Test Method Validation
  • Knowledge of and/or working experience with external standards and regulations: ISO 13485, and 21 CFR 820 (FDA cGMP/QSR), especially pertaining to product development, design controls, good manufacturing practices, supplier qualification and management, quality control, CAPAs and customer complaints
  • Strong verbal and written English language communication skills, including experience in technical protocol and report writing
  • Ability to work in collaboration with cross-functional groups and teams including R&D, Manufacturing, and Quality Assurance to accomplish results with minimal guidance
  • “Hands-on” self-starter with ability to work both independently and as part of a team
  • Training or equivalent work experience with general computer use and software applications (e.g. Microsoft Word, Excel, Power Point, Visio and Access).
  • Knowledge of and/or working experience with statistical software tools (i.e. Minitab) 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 engineering activities
APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Principal Mechanical Engineer

Summary:

As a Principal Mechanical Engineer, you will lead dedicated product development teams to bring complex mechanical designs from concept to market. You will be responsible for the development of long-term implants, delivery systems and external medical devices.

Responsibilities:

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

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

Qualifications:

  • BS in Mechanical / Biomedical Engineering with minimum 10-15 years’ experience within the Medical Device industry
  • Experience with development of permanent implants and delivery systems highly preferred
  • Extensive experience in development of mechanical and electro-mechanical medical devices from concept through design verification and transfer to manufacturing
  • Knowledge of materials and processes used in manufacture of catheters and development of Nitinol components highly preferred
  • Strong understanding of mechanical component manufacturing (i.e. injection molding, machining, sheet metal fabrication, etc.)
  • Proven experience and proficiency using Solidworks for mechanical design
  • Strong working knowledge and understanding of GD&T
  • Excellent communication skills, both written and oral
APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Sr. Electrical Engineer

Summary:

Based out of our facility in Chandler, AZ, or Los Gatos, CA the Senior Electrical Engineer will be responsible for design and development of electronic systems as part of novel Class II/III medical devices.

Responsibilities:

  • Develop and implement circuit designs, including circuits for analog input signal conditioning, embedded control, telemetry, inductive power coupling, power supplies, battery systems, power management and battery charging
  • Develop electronic system and sub-system requirements, and development plans
  • Perform detailed design and analysis to achieve product performance, cost, reliability, manufacturability requirements
  • Design and/or lead design of printed circuit assemblies and electromechanical assemblies, including prototype development, testing and troubleshooting
  • Collaborate with software engineering team to specify, test and verify embedded software and firmware in the system.
  • Interface with and manage suppliers to fabricate prototype and final design components
  • Participate in architecture design, subsystem requirements partitioning, requirements management and configuration management during product development
  • Build, test, debug, and maintain configuration of prototype assemblies
  • Develop test plans and protocols, and execute prototype testing and formal design verification testing
  • Perform Failure Mode Effects Analysis and participate in creation of risk management documentation
  • Develop and maintain documentation for specifications, designs, test plans and reports for inclusion in medical product Design History Files
  • Create and release medical device manufacturing process instructions, bills of material, lot history travelers, and related documentation
  • Participate in the development of quality inspection and manufacturing process instructions for electronic assemblies

Qualifications:

  • Bachelor of Science degree in Electrical Engineering or equivalent. Advanced degrees preferred.
  • Expert level skills in electronic circuit design and commercial product design experience in areas of Neuromodulation, Embedded Control Design, Battery System and Power Management Circuits, Real-time Signal Processing, Wireless Charging and Communication highly preferred.
  • Expertise in electronic design automation tools: e.g.: PCB design (Altium preferred), schematic capture, analog and digital circuit simulation, tolerance analysis.
  • Ability to write C/C++ code for embedded microprocessors is preferred.
  • 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

Site Quality Manager

Summary:

This position will be responsible for the Leadership and management of all site-level Quality-organizational personnel and resources to ensure adherence and compliance to Cirtec Medical’s Quality Management System. The Site Quality Manager shall be the designated Site-Level Management Representative for the Quality Management System of their assigned Cirtec Medical Facility.

Responsibilities:

  • This position may have multiple direct-reporting subordinate Managers and Supervisors in addition to having direct-reporting responsibilities for daily activities of site Quality personnel (responsibility dependent on geographic organizational structure).
  • Designated Site-level Management Representative for assurance of compliance to the Cirtec Medical Quality Management System and member of the Site-Senior Management Team for the facility.
  • Drive and Support Corporate QMS initiatives and continuous improvement activities.
  • Ensure establishment and maintenance of site regulatory registrations (ISO 13485, FDA, etc.).
  • Provide organizational Quality Leadership, coaching, mentoring and guidance to all Quality personnel as well as cross-functional teams.
  • Support for integration of new manufacturing capabilities, product transfers, design transfers and manufacturing customers.
  • Provide Leadership and Guidance for site-level Quality functions including Documentation Control and records retention, Complaint Handling/Returns, Corrective and Preventive Actions, Training, Supplier Quality Management, Nonconforming Material Handling, and Metrology/Calibration Control Systems.
  • Provide oversight and ensure compliance of Quality System support elements for the site QMS: Internal Auditing, Supplier Quality Management, Complaint Handling, Corrective and Preventive Actions, Nonconforming Materials Controls; and the tracking & reporting of associated metrics.
  • Act as site-level Champion for Quality Best Practices and GDP/GMP continuous improvement efforts.
  • Provide Leadership and Guidance for site-level Quality functions including incoming (Receiving & Inspection), in-process inspection, final inspection, and product release support.
  • Provide Leadership and Guidance for site-level Sustained Manufacturing and Continuous Improvement/Continuation Engineering activities and initiatives.
  • Provide Leadership and Guidance for Risk Management (Process FMEAs), Limit Characterization, and Process Qualification (DV&V and PV).
  • Oversee and coordinate site auditing activities (Customer and Customer Regulatory Agencies).
  • Ensure compliance of all site personnel to Corporate and site-level QMS and training requirements.
  • Administration of employment practices, including, but is not limited to, monitoring time & attendance, hiring, terminating, counseling and disciplinary actions for all employees. Responsible to ensure these actions are performed in compliance with Federal and local laws as well as Cirtec Medical policies.
  • Must adhere to professional workplace attire, time, attendance and leave of absence policies.
  • Other duties and responsibilities as assigned.

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

Qualifications:

Required Education & Experience:

  • Minimum 4-Year degree or equivalent of directly transferrable industry work experience (Engineering or Quality discipline preferred).
  • Minimum of 4 years of Leadership/Supervisory-level experience, with budget and decision-making authority/responsibilities.
  • Minimum of 6 years of experience in a regulated manufacturing environment.

Preferred Qualifications & Experience:

  • Advanced Post-Secondary Education/Training/Certification coursework.
  • Quality certification(s) (e.g. ASQ CQT, QCI, etc.).
  • Class I, II and/or III Medical Device manufacturing experience.
  • Regulated manufacturing industry experience (e.g. Aerospace, Defense, Pharmaceutical, etc.)
  • Knowledge and experience with external standards: ISO 900/9001, ISO 13485, and 21CFR 820, EU MDR, especially pertaining to product development, design controls, good manufacturing practices, supplier qualification, auditing, quality control (GD&T, Nonconforming Materials, MRB), Corrective and Preventive Actions, and customer complaints.

Technical Requirements, Skills and Training:

  • Experience in coaching and developing subordinates, utilizing performance management tools and disciplines while increasing employee engagement and retention.
  • Strong verbal and written English language communication skills.
  • Successfully meet Cirtec Medical-specific positional/functional on-the-job training requirements.
  • Competency with 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 variety of functional areas, including R&D, Manufacturing, and QA.

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. Quality Engineer

Summary:

This position is primarily responsible for Design Control (product development), Regulatory compliance, qualitative and quantitative data analysis, complaint investigation and analysis, Manufacturing support, Training, Metrology and Gage R&R, and other Quality functions.   Additionally, this role is expected to provide input and contribute on Quality System strategies and approach.

Responsibilities:

  • Develop and perform operational and process qualifications for customer manufacturing processes in conjunction with other engineering departments.
  • Assist with the development / update of FMEA and Hazard Analysis in conjunction with other engineering departments.
  • Initiate the development / update of FMEA and Hazard Analysis in conjunction with other engineering departments per project requirements.
  • Generate the Quality Plan for development projects.
  • Provide direction in implementing Incoming Inspection plan, First Article Inspection plans, In-Process and Final Product Inspection.
  • Create appropriate sampling plans along with identifying inspection and acceptance criteria.
  • Review and/or document Design Control activities for Project Phase Reviews and Product Verification testing as required per project requirements.
  • Perform vendor audits and qualifications.
  • Represent quality engineering in phase reviews and other aspects throughout product development.
  • Manage the internal audit system schedule and perform the duties of a Lead Auditor including    training internal auditors.
  • Perform internal audits to assess compliance to FDA and ISO 13485 requirements, as well as the internal Quality System, including investigation observations and findings and reporting.
  • Member of customer and 3rd party quality audit team.  May be required to lead this effort.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues, including CAPA’s, CCR’s and NMR’s.
  • Provide 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.
  • Demonstrated use of Quality tools/methodologies including: Design Control, Risk Analysis (Hazard Analysis), Design FMEA, Process FMEA, Statistical Analysis, and Gauge R&R.
  • 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:

  • AS/BA/BS in Quality Engineering or related discipline.
  • Minimum experience in medical/manufacturing environment: 5 years (BS) OR 10 years (AS).
  • Extensive experience with medical device QSRs in design control and production environments.
  • Strong familiarity with Class II or Class III medical devices requirements.
  • Knowledge of FDA/cGMP and MDD regulations/guidelines.
  • Experienced with ISO13485.
  • Must be fluent in use of computer systems for the analysis of data, specifically Microsoft Office.
  • Must possess excellent verbal communication, organizational and management skills.

Preferred Requirements:

  • CQE certification.
  • 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.
  • Demonstrated use of Quality tools/methodologies including: Design Control, Risk Analysis (Hazard Analysis), Design FMEA, Process FMEA, Statistical Analysis, and Gauge R&R.

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

Thin Film Process Development Engineer

Summary:

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

Responsibilities:

  • Attends and arranges project meetings to discuss current and future design and development initiatives.
  • May serve as a primary contact with clients on projects of low to moderate complexity.
  • Assist with preparation of proposals and quotations for clients; interface as needed to resolve questions in a timely manner.
  • Assist in preparation and maintaining of project plans to satisfy milestones, deadlines, budgets, and medical device quality regulations with required actions. Have input to project manager for tracking and communicating project status, plans, issues, timelines, action items, and budgets.
  • Responsible for the following project inputs:
    • Feasibility builds, documentation, and testing
    • Equipment selection, and technology identification in support of high-volume manufacturing of thin film devices
    • Process development of, metallization system using thin film deposition and plating methods
    • Development of photolithography and etching processes (wet and dry)
    • Process Failure Mode Effects Analysis
    • Prototype builds
    • Process Validation
  • Involvement in the full design, development, and validation requirements of projects, including:
    • Product design and specification creation
    • 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.

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.
  • Must maintain high ethical standards
  • Must demonstrate good organizational skills.
  • Must be able to read, write and speak fluent English.
  • A Bachelor’s degree in an engineering discipline and minimum 4 years appropriate work experience; or Associate’s degree in engineering discipline and a minimum or 6 years appropriate work experience; or a minimum 10 years relevant work experience; or equivalent.
  • Experience in an engineering and cleanroom manufacturing environment with a focus on mechanical, photolithography, wet and dry etching manufacturing processes.
  • Experience with thin film metallization deposition equipment and customer process development.
  • Experience with manual and automatic photolithography equipment and development of custom processes.
  • Experience developing wet and dry etching processes.
  • Strong computer skills, including the MS Office suite and MS Project.
  • Must be able to fully interpret technical drawings, blueprints, specifications & illustrations.
  • Strong analytical skills, must be able to obtain, evaluate, and apply secondary research information
  • Ability to learn and apply new technology.
  • Technical report preparation and formal presentation skills.

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

Equipment Maintenance Technician

Summary:

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

Responsibilities:

  • Responsible for preventative and corrective maintenance on all fab / plating area tool sets, including component disassembly / assembly / repair.
  • Responsible for identifying needed parts for repairs / preventative maintenance.
  • Properly hand and store chemicals and hazardous waste..
  • Maintain written logs of maintenance and repairs in our online system.
  • Ensure that facility maintenance requirements are consistently met.
  • Promptly respond to facilities related issues and ensure effective resolution.
  • Keep apprised of current regulations in order to effectively address and ensure compliance with ADA (Americans with Disabilities Act), OSHA (Occupational Safety & Health Administration), fire codes requirements, and Material Management for Hazardous Material.
  • Other duties as assigned.

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

Requirements:

  • Minimum 4 years’ experience in performing preventative and corrective maintenance on semiconductor related equipment.  Similar equipment experience will be considered.
  • Able to troubleshoot electronic circuits to a component level.
  • Familiar with vacuum systems.
  • Must have good computer, written and oral skills.
  • Manual dexterity and visual acuity are required to perform responsibilities.
  • Must be able to lift 60 lbs.
  • Must be willing to work some weekends, alternating coverage with other maintenance techs.
  • Must be legally authorized to work in the United States.
  • Extensive experience with supplier negotiations and supplier 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 60 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

Facilities Manager

Summary:

This position is primarily responsible for the day-to-day implementation of policies, procedures, and programs that will assure a well-maintained facility. Maximum emphasis is placed on positive response to the concerns and needs of the company and its environmental health and safety. This is a hands-on position that coordinates the activities, suppliers, and manpower required for current and future needs of the facility within constraints of time, quality and cost.

Responsibilities:

  • Design, plan and manage all aspects of the facilities function for the facility, which may include but is not limited to maintenance, equipment, machinery, construction, building space allocation and layout, office services, leased properties and furnishings, and building security.
  • Plan, budget and schedule facility modifications and moves, including cost estimates, bid sheets, layouts, and contracts for construction and acquisition.
  • Ensure all interior space requirements, building layout/footprints, architectural elements, corporate environments demands, aesthetics, department work requirements and HVAC (Heating, Ventilating, Air Conditioning) needs are consistently met and maximized.
  • Participate in negotiation of service contracts with outside suppliers.
  • Ensure projects are completed within time and budget specifications.
  • Maintain knowledge of current and emerging trends in technologies, techniques and approaches in space planning and allocation, and space optimization methodology.
  • Establish and enforce safety, security, and emergency guidelines.
  • Ensure that facility maintenance requirements are consistently met.
  • Promptly respond to facilities related issues and ensure effective resolution.
  • Keep apprised of current regulations in order to effectively address and ensure compliance with ADA (Americans with Disabilities Act), OSHA (Occupational Safety & Health Administration), fire codes requirements, and Material Management for Hazardous Material.
  • Other duties as assigned.

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

Requirements:

  • Minimum 10 years’ experience in facilities management to include the following: design, construction, build out, interiors, branding, space planning, maintenance and custodial development
  • Extensive experience with supplier negotiations and supplier management
  • Strong project management skills and an ability to oversee multiple projects simultaneously
  • Excellent communication skills and leadership skills with the ability to influence multiple business partners across all levels
  • High level of customer service aptitude
  • Proven track record of resolving complex business issues and making sound decisions
  • Prior experience in complying with OSHA and ADA regulations
  • Knowledgeable in establishing and enforcing safety, emergency and security procedures
  • Experience with sustainable design or energy use reduction methods

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

Materials Coordinator

Summary:

This position is primarily responsible for inventory control, order entry, creation of shipping documentation, job closings, and inventory reconciliation. Will be required to work closely with the following departments: Production, Finance, Purchasing providing general office support.

Responsibilities:

  • Review jobs requiring materials via the ERP system.
  • Enters new orders, processes change orders and RMAs in M2M.
  • Issue materials to assigned jobs physically and in ERP system.
  • Return materials from completed jobs physically and in ERP system.
  • Perform monthly cycle count in assigned area(s).
  • Communicate any material shortages to appropriate departments as needed.
  • Prepare outgoing shipments to subcontract suppliers.
  • Close all production jobs, verifying material issues before doing so.
  • Copy all documents necessary for and file into the DHR file.
  • Prepare shipping documentation in support of AR invoicing.
  • Provide customers with Inventory reports of their material as requested.
  • Create “customer supplied” materials purchase orders.
  • Support customer service with releasing job orders to the floor.
  • Maintain and monitor manual or computerized inventory control system for raw materials and finished stock.
  • Investigate all discrepancies.
  • Perform cycle counts and assist with annual physical inventory as required.
  • Support or provide back-up to Shipping, Production and Inventory Control functions as required.
  • Respond to customer inquiries regarding invoices and proof of delivery as well as inventory reports for materials
  • Complete shipping and invoicing processes.
  • Process credits/rebills, EDI, collections and invoicing issues.
  • Manage process for completing NDAs and supplier surveys.
  • Order and maintain office and printer supplies as needed.
  • Answers incoming telephone calls- directing to appropriate individuals, or taking messages as required, in addition to meeting/greeting guests as needed.
  • Other duties as assigned.

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

Qualifications:

  • Minimum 2 years previous experience working a front desk in a fast-paced environment.
  • High School level education, with good customer service and communication skills (both written and oral).
  • Excellent organizational skills and great follow through.
  • Ability to maintain confidentiality.
  • Willingness to multi-task, performing a variety of duties and assist various functions in the organization.
  • A proactive problem solver.
  • Minimum five years’ experience in a manufacturing environment, two years of which include operation of an automated inventory control system, a plus.
  • Inventory management and control disciplines.

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

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
  • Ability to travel to sister sites (approximately 5-10%)

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

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 blueprints and interpret technical specifications and illustrations.
  • Experience in technical report writing and verbal communication skills.
  • Minimum 3+ year’s supervisory experience in a manufacturing environment, preferably in a medical device manufacturing environment and in leadership role.
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