Sr. Principal Engineer, Pdo & Verification

BAXTER HEALTHCARE PTY AUS

Raleigh, NC, US
$144,000 - $216,000; annual incentive bonus; compr...
Medical device systems design
Digital platform architecture
Systems engineering
Design and develop medical device systems and digital platforms, ensuring compliance with regulatory and business standards from concept to commercialization

Job Summary

  • Design and develop medical device systems and digital platforms, ensuring compliance with regulatory and business standards from concept to commercialization.
  • Develop and maintain verification and validation plans, test protocols, and reports to comply with FDA and industry standards.
  • Baxter offers comprehensive compensation and benefits packages for eligible roles, including medical and dental coverage that start on day one.

Matching Summary

Design and develop medical device systems and digital platforms, ensuring compliance with regulatory and business standards from concept to commercialization.

Salary

$144,000 - $216,000; Annual incentive bonus; Comprehensive benefits

Skills & Requirements

Must-have

  • Medical device systems design
  • Digital platform architecture
  • Systems engineering
  • Risk management ISO 14971
  • Verification and validation plans
  • Kubernetes integration testing

Nice-to-have

  • User interface design
  • Design thinking
  • Team training and mentoring
  • Cloud environments
  • HL7/FHIR interoperability

Key Requirements

  • Bachelor's degree in Electronics Engineering and Communications or related field
  • 8 years of related experience
  • Experience translating user needs into system requirements
  • Experience with risk evaluation in compliance with ISO 14971
  • Experience analyzing system behavior under FDA guidelines
  • Experience leading verification and validation of medical devices
  • Experience with Kubernetes based medical device monitoring platforms

Work Rights

Not specified

Tailored Resume

Cover Letter