Job Description
Summary
Proficiency in CAD (SolidWorksPTC Creo), GDT, tolerance analysis, and fixture design.
Strong capability in test protocol report writing, statistical analysis (, 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 , ISO , and regulatory pathways ((k), PMA, MDR).
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. Roles Responsibilities Lead DHHRMF Build activities, ensuring adherence to design control requirements per ISO and FDA CFR Part .
Execute Design Verification and Validation (DVV) protocols, inc...