Lead Validation Manager — Medical Devices & FDA

Integrated Resources Inc.; Hercules (MO); On-site; USD 110,000 - 160,000; Full time

Job summary

Integrated Resources, Inc. is seeking a Validation Manager in Hercules, CA, to oversee verification and validation activities for medical device projects.

The role requires leading a small team of validation engineers, serving as SME for V&V, and developing protocols to verify specifications and customer requirements. The candidate will analyze test data, document protocols and reports, and support root cause analyses with corrective actions.

Qualifications

• BS/MS in Engineering or Physical Sciences required.
• 5-7 years in medical device validation/FDA regulated industry.
• 3-5 years of management leadership experience.

Responsibilities

• Lead engineering verification and validation activities.
• Serve as SME for all verification and validation activities.
• Develop and oversee verification protocols to verify engineering specifications.
• Develop and oversee validation protocols to validate customer requirements.
• Analyze verification and validation test data.
• Document test protocols and reports.
• Support Root Cause Analyses and develop corrective measures.
• Support reliability improvement projects.

Skills

Fluidics

Automation

Robotics

Packaging

Site validation

DI Water Systems

Education

BS/MS in Engineering or Physical Sciences

Tools

MS Office Suite

Minitab

Job description

Integrated Resources, Inc. is seeking a Validation Manager in Hercules, CA, to oversee verification and validation activities for medical device projects.

The role requires leading a small team of validation engineers, serving as SME for V&V, and developing protocols to verify specifications and customer requirements. The candidate will analyze test data, document protocols and reports, and support root cause analyses with corrective actions.