Design Engineer

3 days ago

Cleveland, Ohio, United States Katalyst CRO Full time $120,000 - $180,000 per year

Summary

  • Proficiency 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.

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