Sr. Manager - Systems Engineering

Position: Sr.

Manager - Systems Engineering Location: Raleigh, NC Role: Hybrid.

On site 3 days Relocation: 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 & StrategyDirect 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 ExecutionOversee 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 & QualityChampion 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 & PerformanceRecruit, 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.