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