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