Product Development EngineerMedical Device

Product Development Engineer – Medical Device

Location: Aurora, OH

Salary: $70,000.00‑$80,000.00 (posted 1 month ago)

Employment type: Full‑time

Seniority level: Mid‑Senior level

Job function: Engineering and Information Technology

Industries: Biotechnology Research;
Civil Engineering

• Lead product development for orthopedic implants and instruments from concept through design transfer.
• Author and execute test protocols and reports per ASTM/ISO standards, ensuring risk‑based acceptance criteria and regulatory compliance.
• Act as primary liaison with testing labs, preparing technical data packages, approving fixtures, clarifying protocol details, ensuring proper sample handling and chain‑of‑custody.
• Support lab test execution by coordinating logistics, reviewing set‑up photos/videos, witnessing critical tests, and resolving deviations promptly.
• Maintain design controls and risk management per ISO 14971 and 21 CFR 820 throughout project lifecycle.
• Plan and perform design verification and validation (DVV) including benchtop, simulated use, and preclinical testing.
• Collaborate with manufacturing and suppliers for DFMA, process validations, and design transfer readiness.
• Competence in risk management tools (DFMEA, pFMEA) and traceability from requirements to verification.
• Skilled in project management and cross‑functional communication, using tools like MS Project, Minitab.
• Proficiency in CAD (Solid Works, Creo), GDT, tolerance analysis, and fixture design.
• Knowledge of orthopedic testing standards (ASTM F382, F543, F1717, F2077, ISO …).
• Strong capability in test protocol report writing, statistical analysis (tolerance intervals), data integrity practices.
• Familiarity with materials and processes:
  Ti alloys, CoCr, stainless steel, UHMWPE, PEEK, AM, coatings.
• Understanding of design controls, ISO 13485, ISO 14971, and regulatory pathways (510(k), PMA, MDR).
• Experience with external lab management: protocol alignment, fixture approval, deviation handling, report review.

• 4–6 years of experience in Supplier Quality or Product Quality Engineering in medical device industry.
• Strong knowledge of design controls, risk management, and ISO regulations.
• Proficiency in CAD, GDT, and tolerance analysis.
• Experience with ASTM and ISO orthopedic testing standards.
• Project management skills, cross‑functional communication, familiarity with MS Project, Minitab.
• Experience in managing external laboratories and test protocols.