Systems Developer
Core
Define, develop, and verify system and software requirements for innovative medical device products throughout the product development lifecycle.
Role type
Systems Engineer (Medical Devices)
Builds
Medical device products for organ transplantation and donor organ care
Domain
Medical Technology / Organ Transplantation
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Requirements management, risk management, verification and validation planning, design reviews, regulatory submission support, safety and EMC testing coordination, design change management, clinical feedback translation, QMS maintenance
Preferred skills
M.Sc degree, knowledge of IEC 60601, knowledge of Canada/USA/Europe medical device regulations, project planning/management
Technologies
None explicitly stated
Responsibilities
Define user and system/software requirements, coordinate with mechanical/electrical/software teams, create and execute verification and validation plans, assess product reliability, investigate design issues, write test reports, maintain risk and usability files, organize design reviews, coordinate safety and EMC testing, translate clinical user feedback into requirements, maintain design history file, plan and document design changes, contribute to regulatory submissions, support preclinical and clinical studies, enhance QMS documentation
Seniority
Mid-level (4+ years experience)
