Sr. Principal Engineer, Pdo & Verification

BAXTER HEALTHCARE PTY AUS

Raleigh, NC, US
Base: $144,000 - $216,000; bonus: annual incentive...
Medical device system design
Iso 14971 risk management
Iec 62304 software lifecycle
Baxter is seeking a Sr. Principal Engineer to design and develop medical device systems and digital platforms ensuring full regulatory compliance from concept to commercialization

Job Summary

  • Baxter is seeking a Sr. Principal Engineer to design and develop medical device systems and digital platforms ensuring full regulatory compliance from concept to commercialization.
  • The role requires extensive expertise in risk management per ISO 14971 and verification/validation activities aligned with IEC 62304 and FDA guidelines.
  • Employees enjoy comprehensive benefits including medical coverage starting day one, a 401(k) match, and paid time off ranging from 20 to 35 days.

Matching Summary

Baxter is seeking a Sr. Principal Engineer to design and develop medical device systems and digital platforms ensuring full regulatory compliance from concept to commercialization.

Salary

Base: $144,000 - $216,000; Bonus: Annual incentive bonus included; Benefits: Comprehensive health, dental, 401(k) match, ESPP, and PTO

Skills & Requirements

Must-have

  • Medical device system design
  • ISO 14971 risk management
  • IEC 62304 software lifecycle
  • Kubernetes and Docker integration
  • HL7/FHIR interoperability standards
  • PostgreSQL/MySQL clinical data
  • FDA regulatory compliance

Nice-to-have

  • Systems engineering and design thinking
  • Mentoring and training teams
  • International travel willingness
  • Customer needs translation skills
  • Cloud environment validation experience

Key Requirements

  • Bachelor's degree in Electronics Engineering or related field
  • 8 years of related experience
  • Hands-on experience with Kubernetes and Docker
  • Expertise in HL7 messaging standards
  • Knowledge of HIPAA regulations

Work Rights

Not specified

Tailored Resume

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