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Baxter Logo Baxter · Research and Development

Sr. Principal Engineer, PDO & Verification

United States, Raleigh Employment contract 144000.00 - 216000.00 USD / Year · Job Posted April 23, 2026
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Job Description

Design and develop medical device systems and digital platforms, ensuring compliance with regulatory and business standards from concept to commercialization; Create and maintain product and software architecture, user interface design, and specifications that meet customer needs and regulatory requirements; Utilize systems engineering and design thinking to define functional and performance requirements for products and systems; Model behaviors across systems and conduct risk analysis from a systems perspective; Perform risk management activities, including analysis, evaluation, and mitigation, in accordance with ISO 14971; Develop and maintain verification and validation plans, test protocols, and reports to comply with FDA and industry standards; Conduct integration and system validation testing for Kubernetes-based digital platforms in On-Prem and Cloud environments; Prepare technical documentation (design plans, traceability matrices, test reports) in compliance with FDA-approved quality processes for Class I/II and MDDS products; Train and mentor the systems team.

Job Responsibility

  • Design and develop medical device systems and digital platforms, ensuring compliance with regulatory and business standards from concept to commercialization
  • Create and maintain product and software architecture, user interface design, and specifications that meet customer needs and regulatory requirements
  • Utilize systems engineering and design thinking to define functional and performance requirements for products and systems
  • Model behaviors across systems and conduct risk analysis from a systems perspective
  • Perform risk management activities, including analysis, evaluation, and mitigation, in accordance with ISO 14971
  • Develop and maintain verification and validation plans, test protocols, and reports to comply with FDA and industry standards
  • Conduct integration and system validation testing for Kubernetes-based digital platforms in On-Prem and Cloud environments
  • Prepare technical documentation (design plans, traceability matrices, test reports) in compliance with FDA-approved quality processes for Class I/II and MDDS products
  • Train and mentor the systems team.

Requirements

  • Bachelor’s degree in Electronics Engineering and Communications or related field plus 8 years of related experience
  • Translate Customer/end user needs, design constraints, and regulatory mandates into comprehensive system requirements, including functional, non functional, and performance specifications for medical devices and health software
  • Perform comprehensive risk evaluation in compliance with ISO 14971, ensuring identification, analysis, and control of medical device risks
  • Analyze system behavior for complex medical products under FDA guidelines in accordance with IEC 60601-1 and IEC 80601-1 standards
  • Lead the verification and validation of medical devices and health software in strict accordance with IEC 62304 and IEC 82304, ensuring traceability, regulatory compliance, and adherence to FDA recognized software development lifecycle standards
  • Develop and maintain comprehensive verification and validation plans for medical devices and health software, including detailed test protocols, execution records, and test reports, ensuring full traceability, regulatory compliance with FDA requirements, and alignment with engineering best practices and standards such as 21CFR-820
  • Perform integration and validation testing of Kubernetes based medical device monitoring platforms across On Prem and Cloud, leveraging Docker, Kubernetes, MQTT, and RabbitMQ with secure API driven communication to ensure interoperability and compliance in regulated healthcare environments
  • Create and maintain regulatory compliant technical artifacts—including development plans, test protocols, traceability matrices, and verification/validation reports—in alignment with FDA requirements and medical device industry standards such as IEC 62304 and ISO 13485
  • Plan and prepare the test environment for integration of medical devices with Electronic Medical Record (EMR) systems, ensuring interoperability, data integrity, and patient safety in compliance with FDA regulations, IEC 62304 software lifecycle requirements, and HL7/FHIR interoperability standards
  • Expertise in IHE Patient Care Device (PCD) Alarm Communication Management Profile, which uses HL7 messaging standards to communicate between medical devices and alert management systems
  • Hands-on experience with PostgreSQL/MySQL clinical data repositories, ensuring precise data handling, integrity, and adherence to FDA and HIPAA regulations
  • 20% international and domestic travel required to meet customers to understand user needs and clinical workflows.

What we offer

  • Support for Parents
  • Continuing Education/ Professional Development
  • Employee Heath & Well-Being Benefits
  • Paid Time Off
  • 2 Days a Year to Volunteer
  • medical and dental coverage
  • insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
  • Employee Stock Purchase Plan (ESPP)
  • 401(k) Retirement Savings Plan (RSP)
  • Flexible Spending Accounts
  • educational assistance programs
  • paid holidays
  • paid time off ranging from 20 to 35 days based on length of service
  • family and medical leaves of absence
  • paid parental leave
  • commuting benefits
  • Employee Discount Program
  • Employee Assistance Program (EAP)
  • childcare benefits
  • annual incentive bonus
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