Medical Device V&V Lead — Senior Test Engineer (Hybrid)

Lancesoft; Lafayette (CO); Hybrid; USD 120,000 - 150,000; Full time

Job summary

*** is seeking a Test Engineer in Lafayette, CO to drive verification and validation activities for the Emprint product line within the Neuromodulation Interventional organization. You will develop plans, execute tests, and document results to support regulatory submissions.

Join a cross-functional team focused on delivering minimally invasive tumor treatments, with emphasis on system-level verification, risk management, and collaboration with design, manufacturing and quality teams.

Qualifications

• Bachelor’s degree in engineering or scientific discipline plus 6 years of technical testing/engineering experience or an 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.
• Strong fundamentals in mechanical and electrical engineering; familiarity with test equipment (e.g., Instron, multimeter).
• Demonstrated ability to work independently and in cross-functional teams.

Responsibilities

• Develop comprehensive plans for verification testing, including test method validation.
• Create verification protocols with sample size justifications and acceptance criteria definitions.
• Drive design input verification for sterilized disposable instruments and systemic interfaces.
• Develop test methods, validation plans, and validation reports.
• Document verification evidence for regulatory submissions.

Skills

Verification & Validation

Test Method Development

Regulatory Documentation

Education

Bachelor’s degree in engineering or scientific discipline

Advanced Degree in engineering or scientific discipline

Job description

*** is seeking a Test Engineer in Lafayette, CO to drive verification and validation activities for the Emprint product line within the Neuromodulation Interventional organization. You will develop plans, execute tests, and document results to support regulatory submissions.

Join a cross-functional team focused on delivering minimally invasive tumor treatments, with emphasis on system-level verification, risk management, and collaboration with design, manufacturing and quality teams.