Senior Systems Engineer
Core
Lead systems engineering tasks for medical device product development, defining system specifications and validating prototypes to meet clinical and regulatory requirements.
Role type
Senior Systems Engineer (Medical Devices)
Builds
New medical device programs and system features
Domain
Healthcare / Medical Devices / Regulatory Compliance
Deliverable
production ML models | product features
Required skills
Systems engineering, system specification definition, clinical application integration, technology assessment, system integration analysis, cost and risk estimation, prototype evaluation, regulatory compliance (FDA), project leadership
Preferred skills
Medical device industry experience, Biomedical Engineering or Electrical Engineering background, manufacturing process knowledge, cross-functional collaboration in matrixed environments
Technologies
FDA regulations, Quality Management Systems (QMS), Environmental Management Systems (EMS)
Responsibilities
Gather and analyze stakeholder requirements for new medical devices, synthesize technical and regulatory constraints to define system specifications, assist in determining clinical priorities, perform technical planning and performance evaluation studies, assign projects and guide team implementation, evaluate prototypes through structured testing, provide input into system verification plans, identify and resolve technical issues
Seniority
Senior, hands-on IC with leadership responsibilities
