Job Description

Job Description:

  • Proficiency in CAD (Solid Works Creo), GDT, tolerance analysis, and fixture design.

  • Knowledge of orthopedic testing standards (ASTM F382, F543, F1717, F2077, ISO (phone number removed), 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, u...

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