Onsite Principal Test Engineer – Medical Device Systems

Medtronic plc; United States; On-site; USD 129,000 - 193,000; Full time

Benefits offered by this job

Health, Dental and vision insurance

401(k) with employer match

Tuition assistance

Job summary

Medtronic plc in Colorado seeks a Principal Test Engineer to lead system-level verification and validation for interventional medical devices from concept to commercialization. You will develop robust test strategies, write verification and validation plans, and drive regulatory-ready documentation with cross-functional partners.

Based in Lafayette, CO, this onsite role requires technical leadership, mentorship of engineers, and collaboration with quality, manufacturing, and regulatory teams to

Qualifications

• Bachelor's degree with 7+ years of engineering or technical testing experience; or Master's with 5+ years; or PhD with 3+ years.
• Experience leading system-level verification/validation planning, execution, and documentation.
• Experience developing test methods, verification protocols, acceptance criteria, and reports.
• Strong knowledge of mechanical and electrical engineering fundamentals and related test equipment.
• Experience collaborating across cross-functional product development teams.

Responsibilities

• Lead system-level verification and validation strategy, planning, execution, and reporting for new product development programs.
• Develop verification protocols, including acceptance criteria, statistical rationale, and sample size justifications.
• Design, validate, and implement test methods to evaluate system compatibility, reliability, mechanical performance, electrical performance, and tissue interaction.
• Generate regulatory submission-ready documentation, including verification reports, validation reports, and verification traceability evidence.
• Lead user needs validation activities in real or simulated use environments and document objective evidence of design effectiveness.
• Facilitate design reviews, risk management activities, and cross-functional decision-making throughout the product development lifecycle.
• Partner with systems, quality, manufacturing, regulatory, marketing, human factors, and engineering teams to ensure compliance with applicable medical device requirements and standards.
• Provide technical leadership and mentorship to engineers, laboratory personnel, and external development partners.

Skills

System-level V&V

Test method design

Regulatory documentation

Cross-functional teamwork

Mechanical & electrical fundamentals

Education

Bachelor's degree in engineering

Master's degree

PhD

Tools

Test equipment

Job description

Medtronic plc in Colorado seeks a Principal Test Engineer to lead system-level verification and validation for interventional medical devices from concept to commercialization. You will develop robust test strategies, write verification and validation plans, and drive regulatory-ready documentation with cross-functional partners.

Based in Lafayette, CO, this onsite role requires technical leadership, mentorship of engineers, and collaboration with quality, manufacturing, and regulatory teams to