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, 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 such as DFMEA and PFMEA, and traceability from requirements to verification.
• Skilled in project management and cross‑functional communication, using tools like MS Project and 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 such as the Design History File (DHF), risk assessments, and engineering reports.
• Support Design Reviews and ensure traceability of requirements throughout the product lifecycle.

4–6 years of experience in medical device design and verification.

Mid‑Senior level.

Contract.

Pharmaceutical Manufacturing.