Senior Medical Device Systems Engineer

Fortive Corporation (SE)

Irvine (CA)

On-site

USD 158,000 - 263,000

Full time

11 days ago
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Benefits offered by this job

Bonus eligible

Job summary

Fortive Corporation (SE) seeks a Staff Systems Engineer to provide advanced technical leadership and hands-on systems engineering for complex medical device systems. You will contribute to system-level architecture, translate requirements, and support development from concept through transfer, while collaborating across disciplines.

The role requires 10+ years of experience and working knowledge of FDA/ISO/QSR requirements, with travel up to 20%.

Qualifications

  • Bachelor’s degree in Engineering or related technical field required.
  • Minimum 10+ years of engineering experience in product or systems development.

Responsibilities

  • Define, develop, and refine system architectures for products and enhancements.
  • Translate user and business needs into testable system requirements and flow-down to teams.
  • Support lifecycle activities from concept through design transfer to manufacturing.
  • Create and maintain system documentation per design control processes.
  • Provide technical guidance and mentorship across disciplines.
  • Support testing, investigations, and risk assessments during development.
  • Interface with suppliers and partners to support design reviews and transfer.

Skills

Systems engineering
System architecture
Requirements tracing
Cross-functional collaboration
Regulatory knowledge
Technical leadership
Verification & validation

Education

Bachelor's degree in Engineering

Job description

Fortive Corporation (SE) seeks a Staff Systems Engineer to provide advanced technical leadership and hands-on systems engineering for complex medical device systems. You will contribute to system-level architecture, translate requirements, and support development from concept through transfer, while collaborating across disciplines.

The role requires 10+ years of experience and working knowledge of FDA/ISO/QSR requirements, with travel up to 20%.

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