Sr. Staff Systems Engineer

BD

Tempe, AZ, USA
Fully remote
Systems architecture and requirements definition
Design control compliance fda iso 13485
System integration and verification protocols
This role leads the development of complex electro-mechanical medical technologies from concept through commercialization while ensuring full design control compliance

Job Summary

  • This role leads the development of complex electro-mechanical medical technologies from concept through commercialization while ensuring full design control compliance.
  • The successful candidate will define system-level requirements, drive integration activities, and mentor engineers to guide technical execution.
  • BD offers an environment where you can make a meaningful impact on innovative healthcare solutions while collaborating with global teams.

Matching Summary

This role leads the development of complex electro-mechanical medical technologies from concept through commercialization while ensuring full design control compliance.

Skills & Requirements

Must-have

  • Systems architecture and requirements definition
  • Design control compliance FDA ISO 13485
  • System integration and verification protocols
  • IEC 6060-1 medical device standards
  • Requirement management tools like Polarion DOORS

Nice-to-have

  • Comfortable navigating ambiguity in agile environments
  • Strong cross-functional leadership without authority
  • Experience with DFM DFSS manufacturability
  • Patent submission and IP development support

Key Requirements

  • Bachelor's degree in Engineering or Scientific field with 8+ years experience
  • Validated R&D experience in complex electro-mechanical systems or medical devices
  • Experience writing and executing system verification and validation protocols

Work Rights

Not specified

Tailored Resume

Cover Letter