Senior System Engineer

Location: Eden Prairie, MN – Local Candidates Only

The Senior Systems Test Engineer will support the development of medical devices through execution of system-level verification and validation activities. The role will focus on test planning, protocol development, test execution, data analysis, and documentation. The engineer will also support requirements management activities, including requirements review, traceability, and verification planning using Jama.

• Develop and execute verification and validation test protocols for medical device systems.
• Document test results and generate verification and validation reports.
• Support development and review of system requirements to ensure completeness, clarity, and testability.
• Maintain requirements traceability and verification records using Jama.
• Support risk management and verification activities associated with product requirements.
• Perform root cause investigation and troubleshooting of test failures.
• Collaborate with systems, software, electrical, mechanical, quality, and regulatory team members.
• Participate in design reviews and product development activities.
• Ensure work is completed in compliance with applicable quality system and regulatory requirements.

• Bachelor of Science in Engineering, preferably Systems, Biomedical, Electrical Engineering, or Mechanical Engineering.
• 5+ years of engineering experience.
• Experience developing and executing verification and validation protocols.
• Experience with requirements management and traceability.
• Familiarity with Jama or similar requirements management tools.
• Working knowledge of systems engineering principles and product development processes.
• Strong technical writing, documentation, and communication skills.
• Ability to work independently and manage multiple assignments.
• Experience supporting requirements development, verification planning, and traceability throughout the product lifecycle.
• Experience with risk management and systems engineering processes.

• Graduate degree in Engineering (Biomedical, EE, ME, or Systems Engineering) or another scientific discipline.
• 5+ years of research and development experience.
• 3+ years of new product development in a systems engineering role.