As a systems engineer working on software as a medical device, you'll be at the intersection of innovation and regulation, collaborating with regulatory, clinical, marketing, and engineering teams to push the boundaries of what's possible in healthcare technology. You'll see the big picture across regulated projects, connecting dots between teams and disciplines while thriving in ambiguous, fast-moving environments.
Your Key Responsibilities
-Support design and architecture of health regulatory and sensor software applications
-Collaborate with cross-functional partners to translate bold product visions into actionable user requirements and engineering designs
-Translate complex technical and regulatory concepts for diverse audiences, from engineers to executives
-Lead strategic initiatives that increase product development efficiency and scalability, and process optimization
-Develop, manage, and maintain design history files and regulatory deliverables
-Conduct impact analysis on design changes and facilitate trade-off discussions across stakeholder groups
What We're Looking For
You're a natural connector who can coordinate across diverse teams while maintaining technical depth. You can cut through ambiguity, communicate with clarity, and learn new domains quickly. Most importantly, you're passionate about using technology to improve human health.
Why This Role Matters
The work that you do is critical to shipping regulated health features, which have the potential to improve health outcomes for millions of people around the world. If you're ready to combine cutting-edge technology with meaningful impact, we'd love to hear from you!
Proven technical leadership with experience bridging cross-functional teams, the ability to influence without authority
Experience with Software as a Medical Device (SaMD) development
Exposure to regulatory and quality systems including design controls, risk management, and verification/validation activities
Bachelor's degree with 5+ years of relevant industry experience OR equivalent combination of education and professional experience
Exceptional written communication, negotiation, and presentation skills
Ability to balance the big picture with a keen eye for detail
Excellent interpersonal skills and ability to work well with all levels of engineers and other teams
Passion for systems engineering best practices and attention to detail that drives high-quality products