R&D Engineer (Systems Engineer) - Medical device

Local to San Diego

Job Description:

We're hiring Systems Engineers (Medical Devices - DHF, V&V and RMF) to lead systems engineering for complex, regulated medical devices including infusion pumps, drug delivery systems or other electromechanical medical equipment. You'll own the system from user needs through architecture, risk management, verification & validation (V&V), and launch, working shoulder-to-shoulder with mechanical, electrical, software, quality, regulatory, and clinical teams.

Responsibilities:

• Translate user needs and clinical/customer requirements into system requirements and measurable design inputs
• Own system-level and subsystem requirements — functional, performance, safety, reliability, interface, and environmental
• Maintain full requirements traceability from user needs through design outputs, V&V, and risk controls
• Develop system architecture, functional decomposition, and allocate requirements across mechanical, electrical, software/firmware, and controls
• Lead Hazard Analysis, FMEA, FTA, and other risk assessments per ISO 14971
• Build and review V&V strategies, protocols, and reports at the system level
• Support Design History File (DHF) documentation and design control activities under FDA QMSR / 21 CFR Part 820 and ISO 13485
• Lead cross-functional root-cause investigations for system-level issues
• Support design transfer, manufacturing readiness, and post-launch improvements
• Apply IEC 60601, IEC 62304, and IEC 62366-1 as applicable to hardware, software, and usability

Qualification

• Bachelor's degree in Systems, Biomedical, Electrical, Mechanical, or Computer Engineering (or related)
• 5+ years of Systems Engineering experience in medical devices, ideally in new product development / R&D
• Hands-on experience with requirements engineering, system architecture, risk management, verification, and validation
• Experience building and maintaining requirements traceability matrices
• Experience with design controls and DHF documentation
• Experience with Hazard Analysis / FMEA / risk control per ISO 14971
• Cross-functional experience across mechanical, electrical, software, quality, regulatory, and clinical/human factors teams
• Working knowledge of FDA, QMSR/21 CFR Part 820, ISO 13485, and ISO 14971
• Experience with a requirements management or ALM/PLM tool (e.g., DOORS, Jama, Polarion, Windchill, Teamcenter)
• Strong technical writing and cross-functional communication skills
• Experience with infusion pumps, syringe pumps, drug delivery systems, or complex electro-mechanical devices
• Familiarity with IEC 60601-1, IEC 60601-1-2, IEC 62304, IEC 62366-1
• Fault Tree Analysis (FTA), Reliability Engineering, or Safety Engineering background
• Experience supporting FDA submissions, audits, or design reviews
• Master's degree in a related engineering discipline

Pay: $50.00 - $80.00 per hour

Work Location: In person