Sr. Systems Engineer | Medical Device | Electro-Mechanical Systems

About the Role

Are you a systems engineering professional who thrives at the intersection of complex electro-mechanical design and cutting-edge medical device development? This is your opportunity to take ownership of technically challenging projects, serve as a key client-facing engineer, and help bring life-changing medical devices to market.

Location: Northwest Minneapolis Metro
Schedule: Full-time, 5 days onsite

What You’ll Do

• Lead the development of electro-mechanical systems and system architecture, backed by thorough documentation aligned with quality system procedures.
• Own the technical project scope across multiple concurrent programs, serving as the primary point of contact for customers.
• Drive requirement development – both internal and customer-facing – and ensure full traceability through verification and validation.
• Contribute to risk management planning, risk analyses, and Hazard Analysis documentation.
• Coordinate system-level analyses including modeling, algorithm development, simulations, and architecture design.
• Facilitate cross-functional technical discussions and design reviews throughout the product realization process.
• Play an active role in identifying technology reuse opportunities and protecting intellectual property.
• Help shape the team – identify training needs, assess technical talent, and contribute to building a high-performing systems engineering function.

What You’ll Bring

• Bachelor’s degree in Engineering or Computer Science; Master’s degree a plus.
• 5+ years of systems engineering experience, ideally in medical devices.
• Working knowledge of IEC 60601, ISO 13485, ISO/EN 14971, and IEC 62304.
• Familiarity with FDA 510(k), PMA, and De Novo submission processes.
• Experience with Class II and/or Class III medical device development.
• Proficiency with Matlab, Simulink, or similar modeling tools is a bonus.
• Experience with requirements management tools is a plus.

Work Authorization

Candidates must be authorized to work in the United States without sponsorship, now or in the future. This position does not offer visa sponsorship.

Why This Role

This isn’t a siloed engineering position – you’ll be a technical leader, a cross-functional collaborator, and a direct contributor to products that matter. If you’re ready to step into a high-impact role where your expertise shapes both the product and the team around you, we want to hear from you.