Lead Systems Engineer

Job Title : Lead Systems Engineer

Location : Raleigh, NC

Type : Hybrid (3 days onsite / 2 remote)

Experience : 10+ Years

Note : OPT / CPT not eligible

Overview

This role shapes software systems for advanced Infusion Pump platforms. You'll lead technical direction, drive system architecture, and guide development teams building life-impacting healthcare solutions.

What You'll Do

Drive best practices in software systems development and full product lifecycle

Provide technical leadership, mentorship, and guidance to engineering teams

Develop solutions for complex software system challenges under tight schedules

Partner with commercial, clinical, and cross-functional teams to translate user needs into system requirements

Decompose system-level requirements into software subsystem requirements

Lead risk analysis for software, from hazard capture to mitigation strategies

Collaborate with verification engineers to define test strategies and develop V&V plans using requirement traceability

Participate in software design reviews for components, subsystems, and features

Plan, estimate, and execute work in an Agile development environment

Improve team processes, enable better collaboration, and support technical decision-making

Transform software requirements into software test architecture and strategy

Support manufacturing, service, and customer training teams during design transfer

Ensure compliance with product development processes and quality system standards

Requirements

Bachelor's degree in an engineering discipline

10+ years of experience in systems or software engineering

Experience working with electro-mechanical devices (preferred)

Strong background in Agile development and product backlog management

Proven ability to lead technical teams and guide architecture decisions

Excellent communication skills, written and verbal

Experience within a regulated industry, ideally medical devices

Strong documentation and requirement-writing abilities