What are the responsibilities and job description for the R&D /Product Development Engineer position at Katalyst CRO?
Roles & Responsibilities
- Proficiency in CAD (SolidWorks/Creo). GD&T tolerance analysts, and fixture design.
- Knowledge of orthopedic testing standards (ASTM F382 F543, F1717. F2077,150 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. Coctainless 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.
- 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
- 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 14971 and 21 CFR 820 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.
