Source description
About the role
Job Title: Sr. Principal Engineer Location: Raleigh, NC Type: Hybrid (3 days onsite / 2 remote)
Experience: 10+ Years Note: OPT/CPT not eligible
Overview
This role shapes software systems for advanced Infusion Pump platforms. You’ll lead technical direction, drive system architecture, and guide development teams building life-impacting healthcare solutions.
What You’ll Do
-
• Drive best practices in software systems development and full product lifecycle
-
• Provide technical leadership, mentorship, and guidance to engineering teams
-
• Develop solutions for complex software system challenges under tight schedules
-
• Partner with commercial, clinical, and cross-functional teams to translate user needs into system requirements
-
• Decompose system-level requirements into software subsystem requirements
-
• Lead risk analysis for software, from hazard capture to mitigation strategies
-
• Collaborate with verification engineers to define test strategies and develop V&V plans using requirement traceability
-
• Participate in software design reviews for components, subsystems, and features
-
• Plan, estimate, and execute work in an Agile development environment
-
• Improve team processes, enable better collaboration, and support technical decision-making
-
• Transform software requirements into software test architecture and strategy
-
• Support manufacturing, service, and customer training teams during design transfer
-
• Ensure compliance with product development processes and quality system standards
Requirements
-
• Bachelor’s degree in an engineering discipline
-
• 10+ years of experience in systems or software engineering
-
• Experience working with electro-mechanical devices (preferred)
-
• Strong background in Agile development and product backlog management
-
• Proven ability to lead technical teams and guide architecture decisions
-
• Excellent communication skills, written and verbal
-
• Experience within a regulated industry, ideally medical devices
-
• Strong documentation and requirement-writing abilities
More at Stark Pharma
Related open roles
LabWare 8 LIMS Configuration & Integration Specialist
(Thousand Oaks, CA, 91361) · Hybrid
Technical Lead – Android Mobile Applications (Medical Device)
San Francisco Bay Area · Onsite
GxP Lab Computing Engineer
United States · Onsite
Clinical SAS Programmer
Remote · United States
MES Engineer
United States · Onsite
Sr. Principal Software Systems Engineer
United States