Atlantic Group · 9 hours ago
Senior Systems Engineer (Medical Devices)
Lowell, MA
Full-time
Onsite
Mid, Senior Level
$70/hr - $83/hr
3+ years expAtlantic Group is partnering with their 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.
B2BHuman ResourcesStaffing Agency
Responsibilities
Lead systems engineering efforts across cross-functional teams spanning hardware, software, mechanical, manufacturing, and quality disciplines
Define user needs, system requirements, and use cases while designing system and subsystem architectures with embedded risk mitigation
Identify hazards and failure modes and maintain end-to-end traceability across requirements, design outputs, and verification and validation activities
Serve as the technical lead for system integration and verification, developing plans, protocols, and reports within a regulated environment
Partner with suppliers and internal SMEs while supporting project execution, Agile processes, and mentoring junior engineers
Qualification
Required
Bachelor's degree in Systems, Biomedical, Electrical, Mechanical, or Computer Engineering required
3+ years of systems engineering experience in regulated product development environments, including at least 2 years leading cross-functional development efforts
Strong knowledge of FDA-regulated medical device development, including ISO 13485, ISO 14971, IEC 62304, and 21 CFR 820.30 requirements
Experience with requirements and lifecycle management tools (Polarion, Helix, DOORS), data analysis tools (MATLAB, Minitab, JMP), and PLM systems such as Arena
Demonstrated proficiency in requirements management, architecture trade-offs, hazard analysis, root cause analysis, verification planning, and Model-Based Systems Engineering
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
Preferred
Master's degree preferred
Company
Atlantic Group
Atlantic Group, founded in 2006, is an industry leader in executive and professional search & staffing.
51-200 employees
H1B Sponsorship
Atlantic Group has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
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Distribution of Different Job Fields Receiving Sponsorship
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Trends of Total Sponsorships
2021 (1)
2020 (1)
Funding
Current Stage
Growth StageLeadership Team
John Ricco
Founding Partner
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