Systems Test Engineer

Job Title:

Systems Test Engineer

Department:

Development

Reports to:

Director of Systems and Performance

Work Location:

In Person - Eden Prairie, MN

Pay Range:

$65,000 - $75,000

About Elucent Medical:

Elucent Medical is a medical device company focused on developing surgical navigation technologies, particularly for cancer surgery, to improve patient outcomes through precision and efficacy. The company's solutions are designed to transform traditional surgical instruments into "smart" tools, enhancing surgical precision and patient outcomes.

None.

• Develop, maintain, and execute system-level verification and validation test protocols for medical device systems in accordance with approved protocols, acceptance criteria, company SOPs, good documentation practices, and applicable FDA/ISO quality-system requirements.
• Design and perform challenge testing for complex clinical workflows, edge cases, realistic use conditions, and risk scenarios.
• Review requirements, user needs, risk controls, and intended-use scenarios to support test coverage, acceptance criteria, and traceability.
• Verify software changes, defects, and work items using Azure Dev Ops or similar lifecycle management tools; document findings, verification evidence, unresolved anomalies and investigation results in appropriate records.
• Identify, document, investigate, and elevate anomalies, test deviations, nonconforming results, usability issues, workflow gaps, performance concerns, and unexpected system behavior.
• Troubleshoot and resolve system interactions involving software, hardware, RF environments, and instrumentation.
• Use scripts, Python-based tools, automation, and data-analysis workflows to support testing, investigations, and engineering decisions.
• Execute testing in accordance with approved procedures, quality-system requirements, applicable standards, and good documentation practices.
• Collaborate with systems, software, electrical, mechanical, quality, regulatory, clinical, manufacturing, and leadership personnel through design reviews, risk reviews, requirements reviews, defect reviews, and software change reviews.
• Support innovation efforts through prototype evaluation, data analysis, exploratory testing, and technical feedback sessions to improve and expand the product portfolio.
• Support manufacturing, field service, and post-market investigations as assigned.

• Required:
  
  Bachelor’s degree in Engineering, Biomedical Engineering, Electrical Engineering, Mechanical Engineering, Systems Engineering, Computer Science, Physics, Mathematics, or a related technical field.
• Required:
  
  0-2 years of relevant engineering, test, verification/validation, quality, software, hardware experience.
• Required:
  
  Ability to follow approved procedures, document objective evidence, apply good documentation practices, and elevate quality, safety, regulatory or technical concerns.
• Preferred:
  Experience working with complex systems involving software, hardware, electrical, mechanical, user interface, and human factors.
• Preferred:
  Experience developing and executing test protocols, engineering studies, and verification activities.
• Preferred:
  Experience verifying software changes and documenting defects using Azure Dev Ops or a similar lifecycle management tool.
• Preferred:
  Experience with data collection, analysis, scripting, automation, laboratory instrumentation, test fixtures, or data acquisition systems.
• Preferred: navigation, imaging, or other medical device experience with exposure to design verification and validation, risk management, or requirements traceability.
• Preferred:
  Exposure to medical device design controls, verification and validation, ISO 13485, ISO 14971, IEC 62304, IEC 62366-1, requirements traceability, risk management or regulated product development.

• Ability to perform assigned testing in accordance with FDA QMSR / 21 CFR Part 820, ISO 13485, ISO 14971, company SOPs, good documentation practices, and approved test procedures.
• Strong analytical, systems-thinking, and problem-solving skills.
• Ability to understand interactions between software, hardware,…