Job Description
Technical Functional Skills
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, using tools like MS Project, Minitab.
Prior Client Biomet Development experience required.
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, using tools like MS Project, Minitab.
Prior Client Biomet Development experience required.
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