Sr. Principal Software Systems Engineer

Stark Pharma Solutions Inc
North Carolina

Job Title: Sr. Principal Software Systems Engineer
Location: Raleigh, NC

Experience: 10+ years
Duration: 12+ Months

About the Role

We're looking for a Senior Principal Systems Engineer to join our software organization and play a key role in advancing healthcare technology. You'll help shape the future of our Infusion Pump Platforms , driving innovation while ensuring compliance with the highest regulatory standards. Your work will directly impact both patient outcomes and the healthcare providers who depend on our solutions.

Key Responsibilities
  • Innovation & Development: Apply best practices in software systems engineering and product lifecycle management to deliver high-performing healthcare solutions.

  • Technical Leadership: Provide technical direction, mentorship, and constructive feedback to team members, fostering continuous improvement.

  • Problem Solving: Develop creative, effective solutions for complex software system challenges on tight schedules.

  • Cross-Functional Collaboration: Translate user needs into precise system requirements in partnership with commercial, clinical, and technical teams.

  • Risk Management: Lead comprehensive software risk analysis, identifying hazards and implementing mitigation strategies.

  • Testing & Validation: Define and support verification and validation strategies, ensuring full compliance with quality standards.

  • Design Reviews: Participate in design and code reviews to improve functionality, safety, and user experience.

  • Agile Execution: Plan, estimate, and deliver tasks using agile methodologies, keeping projects on schedule and within scope.

  • Stakeholder Engagement: Work with manufacturing, service, and customer training teams during design transfer for seamless integration.

  • Compliance: Ensure strict adherence to regulated industry requirements and internal quality systems.

Qualifications
  • Bachelor's degree in Engineering or related discipline.

  • 10+ years of experience in systems engineering, software engineering, or related field.

  • Background working with electro-mechanical devices (preferred).

  • Hands-on experience with Agile methodologies and product backlog management.

  • Strong oral and written communication skills.

  • Experience in regulated industries with deep knowledge of compliance and quality processes.

  • Excellent documentation and specification writing skills.

  • Must be authorized to work in the U.S. (No sponsorship available).

Posted 2025-09-23

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