Principal R&D Systems Engineer - Electrophysiology
Core
Lead systems engineering for the OPAL Mapping System and EP product portfolio, designing integrated solutions for cardiovascular diagnostics.
Role type
Principal Systems Engineer (Medical Devices)
Builds
Integrated electrophysiology mapping systems and software-hardware solutions
Domain
Medical devices / Electrophysiology / Cardiovascular diagnostics
Required skills
Systems engineering principles, requirements management, medical device regulations, electromechanical systems, project management, Agile/Scrum, risk/benefit trade-off analysis, interface definition, configuration management, regulatory submissions, test method development, EMC testing (60601-1)
Preferred skills
Cyber security (IEC 62304), usability engineering, electrophysiology domain knowledge, imaging and signal processing (EEG/EP), simulation and mathematical analysis, mixed HW/SW system design, low noise analog/digital systems
Technologies
IEC 62304, 60601-1, Agile/Scrum tools, requirement management tools, issue tracking tools
Responsibilities
Lead system architecture design aligned with business needs, execute systems engineering activities across the product lifecycle, solve complex systems interaction problems, advise on product risk/benefit trade-offs, define interface requirements and maintain traceability, manage changes to interfaces, provide input for regulatory submissions, plan and analyze test methods
Seniority
Principal, technical lead with mentorship