R&D /Product Development Engineer

Roles & Responsibilities Proficiency in CAD (SolidWorks/Creo). GD&T tolerance analysts, and fixture design. Knowledge of orthopedic testing standards (ASTM F F, F. F, /, etc.). Strong capability in test protocol/report writing statistical analysis (/, tolerance intervals), and data integrity practices. Familiarity with materials and processes: Ti alloys. Coctainless steel UHMWPE, PEEK. AM. coatings. Understanding of design controls ISO , ISO , and regulatory pathways ((k), PMA. MDR). Experience with external lab management, including protocol alignment, fixture approval, deviation handling and report review. Compete in risk management tools (DFMEA EMEA) and traceability from requirement to verification project management and cross functional communication, using tools like MS Project, Minitas Education & Experience Pro Client met 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. 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 and CFR throughout the project lifecycle. Plan and perform design verification and validation (DV&V) including benchtop. smulated use, and preclinical testing. Collaborate with manufacturing and suppliers for DFMA process validations, and design transfer readiness. #J-18808-Ljbffr Katalyst HealthCares & Life Sciences