Senior Medical Device Verification Engineer

Katalyst CRO

Irvine (CA)

On-site

USD 110,000 - 140,000

Full time

6 hours ago

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Job summary

Katalyst CRO is seeking a Design Verification Engineer in Irvine, CA to advance medical device projects through regulated design controls. You will validate test methods, develop fixtures, and generate verification documentation for development-to-launch phases.

The role requires a strong background in Design Verification, IQ/OQ/PQ validation, and statistical methods with experience in ISO 13485/14971 quality systems. Expect collaboration across engineering and QA teams.

Qualifications

Engineering degree with 5–10 years (BS) or 3+ years (MS).
Strong expertise in Design Verification for Medical Devices.
Experience in a regulated environment: 21 CFR 820 and MDR.
Test equipment validation (IQ, OQ, PQ).
Statistical analysis experience and documentation (SOPs, reports).
Proficiency in MS Office, MS Project, SolidWorks, Minitab/JMP.

Responsibilities

Demonstrate creative out-of-the-box thinking to solve problems and develop new technologies to achieve project goals.
Design and execute DOE and fixture development to support feasibility, development, and verification stages.
Define, develop, and validate/transfer test methods.
Create verification plans, protocols, records, and reports; support investigations and issue resolutions.