What are the responsibilities and job description for the Medical Devices SaMD (Software as a Medical Device) - Raleigh NC - Onsite. position at Jobs via Dice?
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Role : Senior Systems Architect Medical Devices
Location : Raleigh NC - Onsite.
Position requirements (Remote/ Hybrid/Fully onsite) : Onsite
Job Description
Must-Have Requirements :
Role : Senior Systems Architect Medical Devices
Location : Raleigh NC - Onsite.
Position requirements (Remote/ Hybrid/Fully onsite) : Onsite
Job Description
Must-Have Requirements :
- Bachelor s degree in an engineering discipline.
- 10 years of experience in systems engineering or 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).
- 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.
- Experience with electro-mechanical devices.
- Collaboration with manufacturing, service, and training teams.
- Technical mentorship and process improvement.
- Requirement tracing and test architecture development.
