About the position
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.
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
Requirements
- Proven technical leadership with experience bridging cross-functional teams, the ability to influence without authority
- Experience with Software as a Medical Device (SaMD) development, including exposure to regulatory and quality systems
- Bachelor's degree with 5+ years of relevant industry experience OR equivalent combination of education and professional experience
Nice-to-haves
- 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
