Senior Systems Engineer

Stark Pharma Solutions Inc
North Carolina

Job Title: Senior Systems Engineer
Location: Raleigh, NC

Experience: 10+ years
Duration: 12+ Months

About the Role

We're seeking a Senior Systems Enginee r to join our software organization and play a key role in developing advanced healthcare solutions. This role focuses on the development and sustainability of our Infusion Pump Platforms , ensuring high-quality, compliant products that improve patient care and healthcare delivery.

Key Responsibilities
  • Lead & Innovate: Drive best practices in software systems development and product lifecycles while mentoring team members and promoting continuous improvement.

  • Problem Solving: Deliver innovative technical solutions for complex system challenges under tight timelines.

  • Cross-Functional Collaboration: Partner with Commercial, Clinical, Manufacturing, Service, and Training teams to align system requirements with real-world needs.

  • Risk Management: Perform risk analysis for software, identifying hazards and implementing mitigation strategies.

  • Testing & Compliance: Define test strategies, support verification/validation planning, and ensure full compliance with quality systems and regulatory standards.

  • Design & Review: Participate in software design reviews and contribute to enhancing system functionality and usability.

  • Agile Execution: Plan, estimate, and deliver tasks within agile frameworks, ensuring project alignment and timely delivery.

  • Stakeholder Engagement: Drive collaboration with internal and external stakeholders to improve processes, practices, and test architectures.

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

  • 10+ years of experience in Systems Engineering or related fields.

  • Experience with electro-mechanical devices (preferred).

  • Strong background in Agile methodologies and product backlog management.

  • Familiarity with regulated industries and compliance requirements.

  • Excellent documentation, oral, and written communication skills.

Posted 2025-09-30

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