Position: System Engineering Manager
Location: Raleigh, NC
Role: Hybrid. On site 3 days
Relocation: Offering relocation
Visa: Not considering visas
System Engineering Manager
In this role, you will lead a high-performing team of software and systems engineers in the development of next-generation embedded and digital technologies for infusion pump platforms. This role is ideal for a strategic and hands-on leader with a strong background in medical device software development, systems engineering, and Agile methodologies.
Medical device industry experience is great but not required. The ideal candidate would come from a highly regulated industry.
Responsibilities:
Leadership & Team Development
- Build, mentor, and lead a cross-functional team of 10 engineers.
- Foster a culture of innovation, accountability, and continuous improvement.
- Coach and motivate team members to achieve high performance and timely delivery.
Software & Systems Engineering
- Oversee the design, development, and optimization of embedded and digital software systems.
- Ensure all solutions meet regulatory, safety, and quality standards for medical devices.
- Manage software requirements, architecture, and risk assessments.
Agile & Project Management
- Champion Agile development practices across the engineering team.
- Drive sprint planning, backlog grooming, and iterative delivery cycles.
- Identify and mitigate technical risks early in the development lifecycle.
- Lead risk management and requirements engineering efforts for software projects.
Stakeholder Engagement
- Serve as the primary representative for the software systems team in cross-functional meetings.
- Communicate effectively with internal and external stakeholders, including product management, quality, and regulatory teams.
Requirements:
- Bachelor's degree in a relevant STEM field.
- 8+ years of experience in software development, with at least 3 years in a leadership role.
- Proven track record in medical device software development(great to have) and systems engineering.
- Strong understanding of software development life cycle (SDLC), Agile methodologies, and IEC standards.
- Experience with tools for requirements management, issue tracking, and risk analysis.
- Ability to solve complex technical problems with innovative, compliant solutions.
- Excellent communication, collaboration, and organizational skills.
- Ability to manage competing priorities and drive alignment across teams.