Development Mechanical Engineer

Summary

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

• Lead DHHRMF Build activities, ensuring adherence to design control requirements per ISO 13485 and FDA 21 CFR Part 820.
• Execute Design Verification and Validation (DVV) protocols, including test planning, execution, and reporting.
• Manage Change Management processes in compliance with ISO 14971 risk management and internal quality procedures.
• Coordinate project activities across cross-functional teams (Quality, Regulatory, Manufacturing, and Supply Chain).
• Create and maintain technical documentation Design History File (DHF), risk assessments, and engineering reports.
• Support Design Reviews and ensure traceability of requirements throughout the product lifecycle.

• Experience Required – 4 – 6 years