Systems Engineer

What You’ll Do:

• Maintain the System View: Act as the holistic thinker for the product—maintaining a clear mental model of the system, identifying roadblocks early, and guide the team toward effective solutions.
• Lead Cross-Functional Integration: Coordinate electrical, mechanical, software, industrial design, and test workstreams to ensure the product functions as a cohesive system.
• Drive Requirements & Traceability: Lead the definition of user needs and product requirements, maintaining clear traceability from requirements to design decisions, risk management, and verification.
• Own Risk Management: Proactively identify, prioritize, document, and manage technical and program risks, working closely with the design team to develop and execute mitigation strategies.
• Act as a Technical Investigator: Use prototypes, proof-of-concept builds, and engineering testing to validate concepts and inform design direction.
• Enable Informed Decisions: Communicate system architecture, progress, risks, and tradeoffs clearly to teams and clients, empowering confident design decisions.
• Guide Compliance & Documentation: Ensure development follows the governing QMS and regulatory standards while maintaining a right-sized Design Development File.

Qualifications:

• 5+ years of applicable experience in electromechanical/embedded system product development
• Degree in a relevant engineering background (e.g Biomedical, Mechanical, Electrical, Software), or equivalent experience
• Experience interpreting and applying medical device standards such as ISO 60601-1, ISO 13485 etc., or similar experience in a regulated industry
• Experience leading cross-functional teams of engineers and designers

While we recognize that top talent comes from all over the world, we are a small team and are not able to offer visa sponsorship at this time. Candidates must be authorized to work in the United States without requiring visa sponsorship