Senior Systems Engineer
Core
Design and develop medical device systems, ensuring alignment with customer needs, regulatory requirements, and business objectives.
Role type
Senior Systems Engineer (Medical Devices)
Builds
New medical device products and product enhancements
Domain
Healthcare / Medical Devices / Electro-mechanical systems
Deliverable
production ML models | product features
Required skills
System architecture definition, requirements development and flow-down, lifecycle execution (concept to manufacturing), system-level documentation, root cause investigation, risk management, change management, engineering test methods
Preferred skills
FDA/ISO/QSR regulatory knowledge, cross-functional collaboration, supplier interface management, statistical concepts in verification
Technologies
None explicitly stated
Responsibilities
Define and implement system architectures for new products; translate needs into testable system requirements; execute development activities across the product lifecycle; develop and maintain system-level documentation; provide technical guidance and mentorship; support system-level testing and failure investigations; interface with suppliers and external partners
Seniority
Senior, hands-on IC