Design Engineer

Design Manufacturing Engineer

Pursue leading orthopedic implant and instrument development with hands‑on laboratory, regulatory, and risk‑management responsibility.

A Design Manufacturing Engineer will lead product development from concept through design transfer, author test protocols and reports, and interface with testing laboratories to meet regulatory requirements.

• Secure controlled lab environments: manage material database, approve fixtures, handle deviations, and review reports.
• Utilize risk‑management tools such as DFMEA and PFMEA, tracing requirements through verification.
• Manage projects and cross‑functional communication using MS Project, Mantis, and similar tools.
• 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 the primary liaison with testing labs: prepare technical data packages, approve fixtures, clarify protocol details, and enforce 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.

• Proficiency in CAD (Solid Works/Creo), GD&T, tolerance analysis, and statistical knowledge.
• Knowledge of orthopaedic testing standards (ASTM F1802, F543, F1814, F1717, ISO 21534, 14243, etc.).
• Strong capability in test protocol/report writing, statistical analysis (T‑Test, tolerance intervals), and data integrity practices.
• Experience 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, NDA).
• Experience with controlled lab environments and prior Biomet Development client experience required.
• 4–6 years relevant experience.

Entry level

Contract

Pharmaceutical Manufacturing