Job Description

Position: Sr. Manager - Systems Engineering

Location: Raleigh, NC

Role: Hybrid. On site 3 days

Relocation: Not offering relocation

Visa: Not considering visas

Sr. Manager - Systems Engineering

Overview

Lead the development of cutting-edge embedded software solutions for a next-generation infusion pump platform. This leadership role is ideal for a seasoned engineering professional passionate about advancing healthcare technology and improving patient outcomes.

Responsibilities:

Leadership & Strategy

• Direct and inspire a team of systems and software engineers, fostering a culture of innovation, accountability, and continuous improvement.
• Own the delivery of software R&D outputs, ensuring alignment with business goals and regulatory standards.
• Represent the engineering function in cross-functional meetings, stakeholder communications, and strategic planning sessions.

Engineering Execution

• Oversee the design, development, and maintenance of software for the infusion pump platforms.
• Lead multiple concurrent projects, ensuring timely delivery and high-quality outcomes.
• Translate clinical and user needs into software requirements and system-level specifications.
• Drive the development of embedded and digital systems that meet stringent safety and compliance standards.

Process & Quality

• Champion Agile methodologies and foster a lean, iterative development culture.
• Lead risk management and requirements engineering efforts for software projects.
• Promote process simplification and continuous improvement initiatives across the team.
• Ensure full compliance with relevant software development standards and regulatory frameworks.

People & Performance

• Recruit, mentor, and develop engineering talent across disciplines.
• Set clear performance expectations and provide regular coaching and feedback.
• Cultivate a high-energy, collaborative environment that supports innovation and excellence.

Requirements:

• Bachelor’s degree in a stem field. Master's degree is preferred.
• 10+ years of experience in software engineering, including leadership roles.
• Proven track record managing teams developing software regulated industries.
• Strong background in systems engineering, embedded software, and digital product development.
• Great to have an understanding of medical device regulatory standards (IEC 62304).
• Experience with software requirements management, risk analysis, and Agile project planning.
• Proficiency with tools such as Jira, DOORS, and other lifecycle management platforms.
• Deep understanding of software development lifecycles (SDLC) and Agile frameworks.

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