Systems Test Engineer

Supervisory Responsibilities

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 escalate 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 address 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, electrical, mechanical, user interface, and clinical use elements.
• Ability to design, execute, troubleshoot, and document system‑level engineering tests.
• Strong documentation skills, including protocols, reports, engineering summaries, defect documentation, and verification evidence, and traceability records.
• Ability to interpret requirements, user needs, risk controls, intended‑use scenarios, and design inputs.
• Ability to verify software changes, document findings, analyze test data, identify trends, and communicate technical conclusions.
• Ability to use or…