Validation design

Validation Design Role at Katalyst CRO

• 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 (DVV) including benchtop, simulated use, and preclinical testing.
• Collaborate with manufacturing and suppliers for DFMA, process validations, and design transfer readiness.

Seniority level: Associate

Employment type: Contract

Job function: Design, Art/Creative, and Information Technology

Industry: Pharmaceutical Manufacturing

Cleveland, OH – $92,620.00 – $ (3 months ago)

Cleveland, OH – $110,000 – $140,000 (1 week ago)

Greater Cleveland – $80,000.00 – $ (2 days ago)

Location:

Cleveland, OH
Salary Range: $65,779.00 – $83,210.00 (2 months ago)

Katalyst CRO is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, disability or any other protected status.