Product Development Engineer - Medical Device

Summary :

• Proficiency in CAD (Solid Works Creo), GDT, tolerance analysis, and fixture design.
• Knowledge of orthopedic testing standards (ASTM F382, F543, F1717, F2077, ISO 1424214243, etc.).
• Strong capability in test protocol report writing, statistical analysis (9595, tolerance intervals), and 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, including protocol alignment, fixture approval, deviation handling, and report review.
• 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.

Roles & Responsibilities :

• Lead product development for orthopedic implants and instruments from concept through design transfer.
• Author and execute test protocols and reports per ASTMISO standards, ensuring risk-based acceptance criteria and regulatory compliance.
• Act as primary liaison with testing labs prepare technical data packages, approve fixtures, clarify protocol details, and ensure 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 the 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.

Education & Experience :

• Skilled in project management and cross-functional communication, using tools like MS Project, Minitab.
• 4-6 years of experience in Supplier Quality or Product Quality Engineering in medical device industry