Product Development Engineer III

Peak Performers has partnered with a global medical technology company to assist in their search for a Product Development Engineer III. In this contract position, you will lead technical efforts to remediate legacy medical devices in compliance with EU MDR regulations, ensuring robust design history files and risk documentation

Major Duties

Lead remediation of legacy medical devices to meet EU MDR requirements, including updates to DHFs, Technical Files, and Risk
Management documentation.
Interpret and apply standards such as ISO 13485, ISO 14971, IEC 60601, IEC 62304, and 21 CFR Part 820 in product documentation and
design updates.
Develop and revise design documentation, including DFMEA, PFMEA, engineering drawings, and verification/validation protocols.
Collaborate with cross-functional teams to support regulatory submissions, CE Marking, and sustaining engineering efforts.
Communicate project status and technical updates to stakeholders, using tools like MS Project and MS Office to manage timelines and
deliverables.

What are we looking for?

Bachelor's in Engineering Degree, minimum
Minimum 5 years of Medical Device Experience preferred
Minimum 5 years experience in mechanical design, new product development of medical devices, or sustaining engineering
Minimum 3 years in product development and/or research/development
Understanding of medical device V&V process and design requirements traceability
Working knowledge of Technical files and Medical Device product development process, Knowledge of current European Medical Device
directives (MDD/MDR) and CE Mark process
Experience in Remediation of QMS, Tech File, DHF and Risk Management File
Experience in EUMDR product remediation PD work a plus

About this position

Rate: $59-60.14/hour
Contract Length: 5 months with possibility of extension
Remote

The Peak Performers difference

Excellent medical health, dental & vision insurance at 60 days
Our employees may choose to participate in a 403(b) retirement plan
Qualified applicants with chronic medical conditions and/or disabilities receive priority placement
We pay weekly through direct deposit
In business since 1994 and thousands of job placements

All employment offers are contingent on the successful completion of a pre-employment criminal background check, in compliance with all applicable federal and state laws.

Applicants for employment with Peak Performers must possess work authorization that does not require sponsorship for a visa now or in the future.

Peak Performers is an equal opportunity employer and will consider all applicants without regard to race, marital status, sex, age, color, religion, national origin, veteran status, disability or any other characteristic protected by law. Peak Performers does not accept unsolicited resumes from headhunters, recruitment agencies or fee-based recruitment services.

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