Senior Systems Engineer (Medical Devices)

About the role

Atlantic Group is partnering with our client to hire a Senior Systems Engineer (Medical Devices) in Lowell, MA. In this temporary role, you will lead systems engineering for FDA-regulated medical device programs, owning requirements, architecture, risk management, and verification from concept through commercialization. You will collaborate cross-functionally to support complex R&D initiatives in a regulated environment. (Temporary Job #47884)

Responsibilities

• Systems Engineering Leadership: Lead systems engineering efforts across cross-functional teams spanning hardware, software, mechanical, manufacturing, and quality disciplines.
• Requirements & Architecture Development: Define user needs, system requirements, and use cases while designing system and subsystem architectures with embedded risk mitigation.
• Risk Management & Traceability: Identify hazards and failure modes and maintain end-to-end traceability across requirements, design outputs, and verification and validation activities.
• Integration & Verification Support: Serve as the technical lead for system integration and verification, developing plans, protocols, and reports within a regulated environment.
• Collaboration & Mentorship: Partner with suppliers and internal SMEs while supporting project execution, Agile processes, and mentoring junior engineers.

Qualifications

• Education: Bachelor’s degree in Systems, Biomedical, Electrical, Mechanical, or Computer Engineering required (Master’s degree preferred).
• Experience: 3+ years of systems engineering experience in regulated product development environments, including at least 2 years leading cross-functional development efforts.
• Industry Knowledge: Strong knowledge of FDA-regulated medical device development, including ISO 13485, ISO 14971, IEC 62304, and 21 CFR 820.30 requirements.
• Technical Skills: Experience with requirements and lifecycle management tools (Polarion, Helix, DOORS), data analysis tools (MATLAB, Minitab, JMP), and PLM systems such as Arena.
• Systems Engineering Expertise: Demonstrated proficiency in requirements management, architecture trade-offs, hazard analysis, root cause analysis, verification planning, and Model-Based Systems Engineering.

Skills

Highly collaborative and organized professional with strong communication skills, experience working with third-party vendors, and the ability to prioritize effectively in fast-paced, regulated environments.

Pay

$70 – $83/hour

Schedule

Monday to Friday (On‑Site)