Senior Systems Engineer; Medical Devices

Overview

Job Overview – Senior Systems Engineer (Medical Devices). Compensation: $70 – $83/hour.

Location:

Lowell, MA.

Schedule:

Monday to Friday (On-Site).

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.

• 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.

• 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 & Attributes: 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.

Qualified candidates will be contacted within 2 business days of application. If an applicant does not meet the above criteria, Atlantic Group will keep your resume on file for future opportunities and may contact you for further discussion.