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Validation design
Validation designKatalyst HealthCares & Life Sciences • Cleveland, OH
Validation design

Validation design

Katalyst HealthCares & Life Sciences • Cleveland, OH
[job_card.30_days_ago]
[job_preview.job_type]
  • [job_card.full_time]
[job_card.job_description]

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 and CFR 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.

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Validation design • Cleveland, OH

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