Senior System Engineer, Medical Device

Job Responsibilities:

• Translate user needs into comprehensive system-level requirements and decompose them into hardware, software, and mechanical specifications.
• Manage requirements development, documentation, and traceability using Jama, DOORS, Polarion, or equivalent tools.
• 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.
• Develop and coordinate system verification and validation (V&V) activities, including reviewing test protocols, execution results, and final reports.
• Maintain the Design History File (DHF) and contribute to FDA submission preparation, regulatory compliance, and audit readiness.
• 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.

Requirements:

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

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

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

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

Additional Capabilities

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