Senior Systems Engineer — MedTech Impact, 9/80 Schedule

huMannity Medtec; Santa Clarita (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

huMannity Medtec is seeking an experienced Senior Systems Engineer to support development of medical device technologies from concept through commercialization. You will collaborate with R&D, Clinical, Quality, Manufacturing, Software, Electrical, Firmware, and Mechanical teams to ensure successful product development and system integration.

The ideal candidate has strong systems engineering background in regulated medical environments and can translate clinical and business needs into

Qualifications

• Bachelor's or Master's in Electrical, Computer, or Biomedical Engineering.
• Experience creating system requirements, specifications, and documentation.
• Experience with verification and validation in regulated environments.
• Knowledge of ISO 14971 and ISO 13485 is preferred.

Responsibilities

• Translate clinical and customer needs into measurable engineering requirements with traceability.
• Develop and maintain system requirements, specifications, and design documentation.
• Lead risk management activities per ISO 14971.
• Lead cross-functional system integration across mechanical, electrical, firmware, software, and sensing technologies.
• Develop verification and validation plans, protocols, and reports to demonstrate compliance.
• Plan and execute system safety and reliability testing.
• Collaborate with Software, Firmware, Electrical, Mechanical, Quality, Manufacturing, and Clinical teams.
• Support design reviews and technical assessments.

Skills

Systems engineering

Requirements management

Risk assessment

Cross-functional collaboration

Education

Bachelor's or Master's in Electrical Engineering

Bachelor's or Master's in Computer Engineering

Biomedical Engineering background

Job description

huMannity Medtec is seeking an experienced Senior Systems Engineer to support development of medical device technologies from concept through commercialization. You will collaborate with R&D, Clinical, Quality, Manufacturing, Software, Electrical, Firmware, and Mechanical teams to ensure successful product development and system integration.

The ideal candidate has strong systems engineering background in regulated medical environments and can translate clinical and business needs into