Job Title : Senior Systems Architect Medical Devices SaMD (Software as a Medical Device)
Location : Raleigh, NC (Onsite)
Must-Have Requirements
- Bachelor's degree in an engineering discipline.
- 10+ years of experience in systems engineering or a related field.
- Authorized to work in the U.S. (no visa sponsorship available).
- Strong documentation and communication skills.
- Experience in regulated industries (e.g., medical devices).
Primary Skills
Systems engineering for software-driven medical devices.Agile development practices, including backlog management.Risk analysis and mitigation for software systems.Defining and executing verification and validation strategies.Leading cross-functional teams and design reviews.Translating user needs into system requirements.Compliance with quality systems and product development processes.Secondary Skills
Experience with electro-mechanical devices.Collaboration with manufacturing, service, and training teams.Technical mentorship and process improvement.Requirement tracing and test architecture development.