Medical Devices SaMD (Software as a Medical Device) - Raleigh NC - Onsite.

Overview

On Site
Hybrid
Depends on Experience
Contract - Independent
Contract - W2
Contract - 12 Month(s)

Skills

Design Review
Mechanical Engineering
Medical Devices
Process Improvement
Quality Management
Risk Analysis
Verification And Validation

Job Details

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).

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.
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