Senior System Engineer, Medical Device

Job Description

Job Responsibilities:

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• Translate user needs into comprehensive system-level requirements and decompose them into hardware, software, and mechanical specifications.

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• Manage requirements development, documentation, and traceability using Jama, DOORS, Polarion, or equivalent tools.

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• Lead hazard analyses and Failure Mode and Effects Analysis (FMEA) in accordance with ISO 14971, ensuring all identified risk controls are incorporated into system requirements and verified through testing.

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• Develop and coordinate system verification and validation (V&V) activities, including reviewing test protocols, execution results, and final reports.

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• Maintain the Design History File (DHF) and contribute to FDA submission preparation, regulatory compliance, and audit readiness.

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• Facilitate cross-functional design reviews with Software Engineering, Quality, Regulatory Affairs, and Clinical teams to ensure alignment with design inputs, risk controls, and product requirements.

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Requirements:

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• BS in Biomedical, Electrical, Mechanical, Systems or Computer Engineering.

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• 5+ years in systems engineering, V&V or a similar role in a regulated medical device environment.

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• Working knowledge of FDA design controls (21 CFR 820), ISO 13485, ISO 14971, IEC 62304 and IEC 60601-1.

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• Hands-on use of a requirements tool such as Jama, DOORS, Polarion or Codebeamer.

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Additional Capabilities: SysML / MBSE, embedded or connected devices, cybersecurity, a 510(k) or PMA submission, Agile.