Design Engineer

SummaryProficiency in CAD (SolidWorks/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).Roles and Responsibilities:Experience with controlled lab environments, including material database, fixture approval, deviation handling, and report reviews.Competency 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, Mantis.Prior Client Biomet Development experience required.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.Education and Experience: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.Experience Required 4 - 6 years.