Biomedical / Mechanical Design Verification Engineer – Orthopedic Implants

Job Title : Biomedical / Mechanical Design Verification Engineer – Orthopedic Implants

Location : Broadview Heights, OH

Long term Contract

JD :

PLEASE NOTE The rates may be negotiable based on experience, education, geographic location, and other factors..

Technical/Functional Skills

• Proficiency in CAD (SolidWorks/Creo), GD&T, tolerance analysis, and fixture design.

• Knowledge of orthopedic testing standards (ASTM F382, F543, F1717, F2077, ISO 14242/14243, etc.).

• Strong capability in test protocol/report writing, statistical analysis (95/95, 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 Zimmer Biomet Development experience required.

Roles & Responsibilities

• Lead product development for orthopedic implants and instruments from concept through design transfer.

• Author and execute test protocols and reports per ASTM/ISO standards, ensuring risk-based acceptance criteria and regulatory compliance.

• Act as primary liaison with testing labs: prepare technical data packages, approve fixtures, clarify protocol details, and ensure proper sample handling and chain-of-custody.

• Support lab test execution by coordinating logistics, reviewing set-up photos/videos, witnessing critical tests, and resolving deviations promptly.

• Maintain design controls and risk management per ISO 14971 and 21 CFR 820 throughout the project lifecycle.

• Plan and perform design verification and validation (DV&V) including benchtop, simulated use, and preclinical testing.

• Collaborate with manufacturing and suppliers for DFMA, process validations, and design transfer readiness.

Education Minimum B.S. degree from an ABET-accredited school (or global equivalent) in one of the following engineering disciplines, 2-4 years of experience: Mechanical Engineering, Mechanical Engineering Technology, Biomedical Engineering, Bioengineering, Biomedical Engineering Technology, Bioengineering Technology, Aerospace Engineering or Aeronautical Engineering. Medical device, particularly the Orthopedic industry, experience preferred.