Engineer/Senior Systems Engineer
Core
Support the lifecycle of innovative healthcare products, ensuring compliance with safety, quality, and regulatory standards.
Role type
Senior Systems Engineer (Medical Devices)
Builds
Medical device products used globally
Domain
Healthcare / Medical Devices
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Systems thinking, Root cause analysis, Hazard analysis, Safety risk assessments, Verification & validation, Design controls knowledge, Regulatory compliance knowledge, Cross-functional collaboration, Project leadership (Senior), Mentoring
Preferred skills
None stated
Technologies
ISO 13485, ISO 14971
Responsibilities
Maintain system requirements and risk management files, Support investigation of field issues, Contribute to post-market surveillance, Participate in design reviews and audits, Ensure end-to-end traceability
Seniority
Senior, hands-on IC with mentorship