Product Engineer jobs in United States
cer-icon
Apply on Employer Site
company-logo

Akkodis Group Nordics · 11 hours ago

Product Engineer

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.

Embedded SystemsSoftware

Responsibilities

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

Qualification

ISO 13485FDA 21 CFR Part 820DV&V protocolsCAD toolsRisk-management frameworksMechanical engineeringBiomedical EngineeringMaterials EngineeringTolerance analysisDFMEA/pFMEATechnical documentation

Required

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

Benefits

Medical
Dental
Vision
Life insurance
Short-term disability
Additional voluntary benefits
EAP program
Commuter benefits
401K plan
Paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law
Holiday pay where applicable

Company

Akkodis Group Nordics

twittertwittertwitter
company-logo
Akkodis Group Nordics, operates as a specialized tech cluster, combining expertise in Digital Engineering and Edge Technology.

Funding

Current Stage
Late Stage
Total Funding
unknown
Key Investors
Reiten & Co
2020-03-16Acquired
2009-05-01Private Equity
Company data provided by crunchbase