Product Development Engineer - Medical Device Job at Katalyst HealthCares and Life Sciences, Broadview Heights, OH

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  • Katalyst HealthCares and Life Sciences
  • Broadview Heights, OH

Job Description

Summary :

  • Proficiency in CAD (Solid Works Creo), GDT, tolerance analysis, and fixture design.
  • Knowledge of orthopedic testing standards (ASTM F382, F543, F1717, F2077, ISO 1424214243, etc.).
  • Strong capability in test protocol report writing, statistical analysis (9595, tolerance intervals), and data integrity practices.
  • Familiarity 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, MDR).
  • Experience with external lab management, including protocol alignment, fixture approval, deviation handling, and report review.
  • Competence 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, Minitab.


Roles & Responsibilities :

  • Lead product development for orthopedic implants and instruments from concept through design transfer.
  • Author and execute test protocols and reports per ASTMISO 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 (DVV) including benchtop, simulated use, and preclinical testing.
  • Collaborate with manufacturing and suppliers for DFMA, process validations, and design transfer readiness.

Education & Experience :

  • Skilled in project management and cross-functional communication, using tools like MS Project, Minitab.
  • 4-6 years of experience in Supplier Quality or Product Quality Engineering in medical device industry

Job Tags

Full time

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