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Design Quality Engineer (Medical Device)

Job Description

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We are currently looking to fill a Medical Device Quality Engineer position. This position will provide Quality Assurance oversight and ensure compliance in the support of combination device development life cycles.

In this role, a typical day might include the following:

  • Reviewing design and development paperwork and records for compliance to internal procedures and regulations

  • Ensuring accurate justification of statistical analysis and hypothesis testing

  • Reviewing technical reports as well as documents for Design History Files

  • Participating in device risk management activities including UFMEA, DFMEA, PFMEA

  • Aiding in establishing statistical controls in development and transfer to manufacturing processes

  • Verifying data integrity, electronic data storage and data sheet validations

  • Reviewing and coordinating with QA Validation for all test method and design validations

  • Reviewing activities related to Design Verification and Design Transfer of Medical Devices

  • Ensuring work product meets regulations

  • Supporting scientific, complaint, and test failure investigations

  • Performing data trend analysis, participating in Phase Reviews, writing Quality Procedures, performing data/statistical analysis

This role might be for you if:

  • You have knowledge of the combination device development process

  • You have experience with device risk management activities

  • You have a quality mind-set

To be considered for this role you must hold a Bachelor’s degree in an Engineering subject area and the following amount of work experience in combination device or medical device industry for each level:

  • Quality Engineer: 2+ years

  • Senior Quality Engineer: 5+ years

Level is determined based on qualifications relevant to the role.


Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

Salary Range (annually)

$72,800.00 - $139,100.00