Systems Test Engineer

Elucent Medical•Eden Prairie, MN

4d•Onsite

About The Position

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.

Requirements

Bachelor’s degree in Engineering, Biomedical Engineering, Electrical Engineering, Mechanical Engineering, Systems Engineering, Computer Science, Physics, Mathematics, or a related technical field.
0-2 years of relevant engineering, test, verification/validation, quality, software, hardware experience.
Ability to follow approved procedures, document objective evidence, apply good documentation practices, and escalate quality, safety, regulatory or technical concerns.
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 develop scripts, automation tools, data-analysis utilities, or engineering tools; Python experience preferred.
Ability to support prototype evaluation, test-method development, technical exploration, and innovation activities in addition to formal verification and validation work.
Ability to work independently with general direction, collaborate cross-functionally, prioritize assigned work, follow quality-system procedures, and escalate risks appropriately.

Nice To Haves

Experience working with complex systems involving software, hardware, electrical, mechanical, user interface, and human factors.
Experience developing and executing test protocols, engineering studies, and verification activities.
Experience verifying software changes and documenting defects using Azure DevOps or a similar lifecycle management tool.
Experience with data collection, analysis, scripting, automation, laboratory instrumentation, test fixtures, or data acquisition systems.
navigation, imaging, or other medical device experience with exposure to design verification and validation, risk management, or requirements traceability.
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.

Responsibilities

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 DevOps 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.