Medical Device Systems Test Engineer – Precision Validation

Elucent Medical Inc.; Eden Prairie (MN); On-site; USD 65,000 - 75,000; Full time

Benefits offered by this job

401(k)

401(k) matching (4%)

Dental insurance

Health insurance

Vision insurance

Paid Holidays

Paid Vacation Days

Paid Sick Days

Short Term Disability

Long Term Disability

Life Insurance

Pet Insurance

Employee Assistance Programs

Job summary

Elucent Medical in Eden Prairie, MN is seeking a Systems Test Engineer to develop, maintain, and execute system-level verification and validation tests for medical device systems.

You will collaborate with cross-functional teams, review requirements, perform anomaly investigations, and document results using approved procedures and FDA/ISO standards. Proficiency with scripting (Python) and Azure DevOps is a plus. This role reports to the Director of Systems and Performance.

Qualifications

• Bachelor's degree in engineering or related field required.
• 0-2 years of relevant engineering/test/verification experience.
• Ability to follow procedures, document evidence, and ensure quality and safety.
• Experience with complex systems involving software and hardware preferred.
• Experience verifying software changes and documenting defects using Azure DevOps or similar.

Responsibilities

• Develop, maintain, and execute system-level verification and validation test protocols for medical device systems.
• Design and perform challenge testing for clinical workflows, edge cases, and risk scenarios.
• Review requirements and risk controls to support test coverage and traceability.
• Verify software changes and document findings and evidence using lifecycle tools.
• Identify anomalies and performance concerns, and document investigation results.
• Troubleshoot system interactions between software, hardware, RF environments, and instrumentation.
• Use scripts and Python-based tools to support testing and analysis.
• Execute testing per approved procedures and quality-system requirements.
• Collaborate with cross-functional teams through design and risk reviews.
• Support innovation through prototype evaluation and data analysis.
• Assist manufacturing, field service, and post-market investigations as assigned.

Skills

Analytical thinking

Systems thinking

Problem solving

Independent work

Cross-functional collaboration

Python scripting

Education

Bachelor’s degree in Engineering

Tools

Azure DevOps

Job description

Elucent Medical in Eden Prairie, MN is seeking a Systems Test Engineer to develop, maintain, and execute system-level verification and validation tests for medical device systems.

You will collaborate with cross-functional teams, review requirements, perform anomaly investigations, and document results using approved procedures and FDA/ISO standards. Proficiency with scripting (Python) and Azure DevOps is a plus. This role reports to the Director of Systems and Performance.