Job Description

Position: Software Systems Engineering Manager

Location: Raleigh, NC

Role: Hybrid. On site 3 days

Relocation: Offering relocation

Visa: Not considering visas

Software Systems 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.

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