Sr. Principal Engineer, Pdo & Verification

Baxter Healthcare Corporation

Raleigh, NC, US
Base: $144,000 - $216,000; bonus/equity: annual in...
Medical device system design and development
Iso 14971 risk management compliance
Iec 62304 software lifecycle verification
Baxter is seeking a Sr. Principal Engineer to design and develop medical device systems and digital platforms that ensure compliance with regulatory and business standards from concept to commercialization

Job Summary

  • Baxter is seeking a Sr. Principal Engineer to design and develop medical device systems and digital platforms that ensure compliance with regulatory and business standards from concept to commercialization.
  • The role requires performing comprehensive risk evaluation in compliance with ISO 14971 and leading the verification and validation of medical devices in strict accordance with IEC 62304.
  • Employees enjoy competitive compensation ranging from $144,000 to $216,000 plus an annual incentive bonus, along with comprehensive benefits including medical coverage starting day one and paid time off.

Matching Summary

Baxter is seeking a Sr. Principal Engineer to design and develop medical device systems and digital platforms that ensure compliance with regulatory and business standards from concept to commercialization.

Salary

Base: $144,000 - $216,000; Bonus/Equity: Annual incentive bonus included; Benefits: Medical/dental day one, 401(k) match, ESPP, 20-35 days PTO

Skills & Requirements

Must-have

  • Medical device system design and development
  • ISO 14971 risk management compliance
  • IEC 62304 software lifecycle verification
  • Kubernetes Docker MQTT RabbitMQ integration
  • HL7 FHIR IHE PCD interoperability standards
  • PostgreSQL MySQL clinical data repositories

Nice-to-have

  • Systems engineering and design thinking approach
  • Mentoring and training systems team members
  • Understanding of clinical workflows and user needs
  • Experience with On-Prem and Cloud environments

Key Requirements

  • Bachelor's degree in Electronics Engineering or related field
  • 8 years of related experience required
  • Expertise in FDA guidelines and IEC 60601-1 standards
  • Hands-on experience with HIPAA regulations and data integrity

Work Rights

Not specified

Tailored Resume

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