Senior Test Engineer, Medical Devices – Hybrid V&V

JobDiva, Inc.; Lafayette (CO); Hybrid; USD 76,000 - 90,000; Full time

Job summary

Primary Talent Partners is seeking a Sr Test Engineer (Manufacturing) in Lafayette, CO for a 12-month contract in the Neuromodulation Interventional line. The role focuses on system verification and validation for interventional medical devices, partnering with multiple engineering functions to drive robust V&V strategies.

The candidate will develop verification plans and protocols, write validation reports, and support design reviews and risk management.

Qualifications

• Bachelor's degree in engineering or scientific discipline with 6+ years of testing/engineering experience or Advanced Degree with 4+ years of experience.
• Experience leading system-level verification planning, execution, and documentation.
• Experience supporting system-level validation planning, execution, and documentation.
• Experience testing devices in ex-vivo tissue.
• Basic knowledge of mechanical and electrical engineering fundamentals.
• Familiarity with IEC 60601 testing standards and electrical safety/EMC testing.

Responsibilities

• Develop verification plans and protocols with sample size justification and acceptance criteria.
• Drive design input verification for sterilized disposable instruments and device components.
• Develop test methods, validation plans, and validation reports.
• Document verification evidence for regulatory submission readiness.
• Support design validation with end-user testing in real or simulated environments.
• Collaborate with quality, systems, mechanical, electrical engineering teams, and suppliers.
• Communicate findings and provide senior technical leadership across teams.

Skills

Verification & Validation

System-level testing

Test method development

Regulatory documentation

Cross-functional teamwork

Execution discipline

Education

Bachelor's degree in engineering or scientific discipline

Advanced degree in engineering or scientific discipline

Tools

Instron

Multimeter

Job description

Primary Talent Partners is seeking a Sr Test Engineer (Manufacturing) in Lafayette, CO for a 12-month contract in the Neuromodulation Interventional line. The role focuses on system verification and validation for interventional medical devices, partnering with multiple engineering functions to drive robust V&V strategies.

The candidate will develop verification plans and protocols, write validation reports, and support design reviews and risk management.