✦ Luna Orbit — Engineering (Non-Software)

Sr. Principal Engineer, PDO & Verification

at Baxter International

📍 Raleigh, North Carolina Onsite 💰 $144K – $216K USD / year Posted April 03, 2026
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Position Details

Salary $144K – $216K USD / year
Type Full-Time
Experience senior
Exp. Years 8 years
Education Bachelor's degree in Electronics Engineering and Communications or related field
Category Engineering (Non-Software)

About this role

Senior principal engineer responsible for PDO & Verification of medical device software platforms, driving architecture, risk management, and regulatory-compliant V&V across On-Prem and Cloud Kubernetes environments.

Key Responsibilities

  • Design and develop medical device systems and digital platforms
  • Create and maintain architecture, UI design, and specifications
  • Model system behaviors and perform risk analysis (ISO 14971)
  • Develop V&V plans and test protocols
  • Lead integration and system validation testing for Kubernetes-based platforms

Technical Overview

Scope includes Kubernetes-based platforms, Docker containers, MQTT/RabbitMQ communication, HL7/FHIR interoperability, and regulatory standards (ISO 14971, IEC 60601-1, IEC 62304, IEC 82304) with PostgreSQL/MySQL data stores and FDA-related artifacts.

Ideal Candidate

The ideal candidate is a senior-level engineer with 8+ years of medical device systems engineering experience, strong regulatory and V&V expertise, and hands-on work with Kubernetes-based platforms on both On-Prem and Cloud environments. They should lead cross-functional teams and drive compliant software verification activities.

Must-Have Skills

Bachelor's degree in Electronics Engineering and Communications or related field8 years of related experienceTranslate Customer/end user needsdesign constraintsand regulatory mandates into comprehensive system requirementsISO 14971IEC 60601-1IEC 62304IEC 8230421CFR-820FDA requirementstraceability matricesverification and validation plansKubernetes-based platforms tested on On-Prem and CloudRegulatory compliant artifactsPostgreSQLMySQLIHE PCD Alarm Communication Management ProfileHL7/FHIR interoperability

Tools & Platforms

KubernetesDockerPostgreSQLMySQLHL7FHIRIHE PCD Alarm Communication Management Profile

Required Skills

KubernetesDockerMQTTRabbitMQPostgreSQLMySQLHL7FHIRIHE PCD Alarm Communication Management ProfileISO 14971IEC 60601-1IEC 62304IEC 8230421CFR-820FDAEMROn-PremCloudtraceability matricesverificationvalidationdesign plans

Hard Skills

KubernetesDockerMQTTRabbitMQPostgreSQLMySQLHL7FHIRIHE PCD Alarm Communication Management ProfileISO 14971IEC 60601-1IEC 62304IEC 8230421CFR-820FDAEMROn-PremCloudtraceability matrices

Soft Skills

leadershipmentoringcommunicationcollaborationproblem-solvingattention to detailregulatory complianceplanning

Industry & Role

Industry Healthcare & Medical
Job Function Lead systems design and verification for regulated medical device software within Kubernetes-based ecosystems
Role Subtype Engineering (Non-Software)
Tech Domains Kubernetes, Docker, SQL / PostgreSQL, MySQL, HL7 messaging standards, EMR interoperability

Keywords for Your Resume

Sr. Principal EngineerPDO & Verificationkubernetesdockermqttrabbitmqpostgresqlmysqlhl7fhirihe pcd alarm communication management profileiec 62304iec 82304iec 60601-1iso 1497121cfr-820fdaemron-premcloudtraceability matricesverificationvalidationdesign plans

Deal Breakers

Bachelor's degree not in relevant field, Less than 8 years of related experience, Unwillingness to travel 20%+, Not willing to work onsite in Raleigh, NC

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