Product Engineer
Listed on 2026-02-03
-
Engineering
Quality Engineering, Biomedical Engineer, Manufacturing Engineer
Overview
Akkodis is seeking a Product Engineer for a Contract with a client in Broadview Heights, OH
. The candidate will lead DHF/RMF build activities and execute design verification and validation protocols in alignment with ISO and FDA requirements.
Rate Range: $30/hour to $36/hour;
The rate may be negotiable based on experience, education, geographic location, and other factors.
- The candidate will lead DHF and RMF build activities while ensuring compliance with ISO 13485 and FDA 21 CFR Part 820 design‑control requirements.
- The candidate will execute Design Verification and Validation (DV&V) activities, including protocol development, test execution, statistical analysis, and reporting.
- The candidate will manage engineering change‑control processes in alignment with ISO 14971 risk‑management practices and internal quality procedures.
- The candidate will coordinate cross‑functional efforts with Quality, Regulatory, Manufacturing, and Supply Chain teams to support project execution.
- The candidate will create and maintain technical documentation such as DHF elements, risk assessments, traceability matrices, and engineering reports.
- The candidate will support design reviews and ensure end‑to‑end requirements traceability throughout the full product development lifecycle.
- Bachelor’s degree in mechanical engineering, Biomedical Engineering, Materials Engineering, or a related technical field.
- 2–4 years of experience in medical device product development, or regulated engineering environments.
- Strong proficiency in CAD tools, GD&T, tolerance analysis, and hands‑on experience with DV&V protocols and risk‑management frameworks such as DFMEA/pFMEA.
- Mandatory prior Zimmer Biomet development experience with working knowledge of ISO 13485, ISO 14971, FDA 21 CFR Part 820, and material/process familiarity.
If you are interested in this role, then please click APPLY NOW. For other opportunities available at Akkodis, or any questions, feel free to contact me at Vikas.
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$30.00 to $36.00 per hour
BenefitsBenefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.
EqualOpportunity
Equal Opportunity Employer/Veterans/Disabled
Military connected talent encouraged to apply
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RequirementsThe Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:
- The California Fair Chance Act
- Los Angeles City Fair Chance Ordinance
- Los Angeles County Fair Chance Ordinance for Employers
- San Francisco Fair Chance Ordinance
Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
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