Senior Design Verification Engineer - Med Devices

Katalyst CRO; Irvine (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Katalyst CRO in Irvine, CA seeks a Senior Design Verification Engineer to drive verification for medical device programs. You will design experiments, develop fixtures, and transfer test methods to meet project timelines while ensuring 21 CFR 820 and MDR compliance.

The role requires a BS (or MS) in engineering with substantial design verification experience, proficiency in SolidWorks and statistical tools, and strong communication for technical reports and cross-functional collaboration.

Qualifications

• BS or MS in engineering with years of experience as specified in the requirements.
• Experience in medical device design verification and regulatory compliance (21 CFR 820 / MDR).
• Experience documenting SOPs, technical reports, and verification plans/protocols/reports.

Responsibilities

• Demonstrate out-of-the-box thinking to solve problems and develop new technologies.
• Design and execute experiments and fixture development for feasibility and verification.
• Define, develop, and validate transfer/test methods.
• Create verification plans, protocols, records, and reports; support investigations.

Skills

Design Verification

Statistical analysis

Documentation & SOPs

Technical reporting

Communication skills

Education

BS in Mechanical Engineering or related field

MS in Mechanical Engineering or related field

Tools

SolidWorks

Minitab

JMP

MS Office

MS Project

GD&T

Job description

Katalyst CRO in Irvine, CA seeks a Senior Design Verification Engineer to drive verification for medical device programs. You will design experiments, develop fixtures, and transfer test methods to meet project timelines while ensuring 21 CFR 820 and MDR compliance.

The role requires a BS (or MS) in engineering with substantial design verification experience, proficiency in SolidWorks and statistical tools, and strong communication for technical reports and cross-functional collaboration.