Not specified; not specified; major medical covera...
Hybrid
8+ years in medical device industry
Bs in electrical or biomedical engineering
Fda 510k and ce mark regulatory knowledge
This role supports Smith+Nephew's mission to design technology that takes the limits off living by ensuring safe and effective medical devices
Job Summary
This role supports Smith+Nephew's mission to design technology that takes the limits off living by ensuring safe and effective medical devices.
The engineer will lead quality efforts for new product development projects requiring FDA 510k and CE Mark approvals while managing verification and validation testing.
Employees enjoy benefits including major medical coverage, flexible personal time off, hybrid work models, and free cab transport facilities.
Matching Summary
This role supports Smith+Nephew's mission to design technology that takes the limits off living by ensuring safe and effective medical devices.
Salary
Not specified; Not specified; Major medical coverage; Educational Assistance; Flexible Personal/Vacation Time Off; Free Cab Transport Facility
Skills & Requirements
Must-have
8+ years in medical device industry
BS in Electrical or Biomedical Engineering
FDA 510k and CE Mark regulatory knowledge
ISO 13485 and ISO 14971 compliance expertise
IEC 62304 software standards understanding
Design Control and Risk Management leadership
Nice-to-have
ASQ CQE or CRE certification preferred
Experience with High Frequency surgical equipment
Proficiency in Jama or Cockpit requirement tools
Jira defect tracking tool experience
C or Python programming language skills
Oscilloscopes and Function Generators proficiency
Key Requirements
B.S. in Electrical, Computer, or Biomedical Engineering
M.S. in Engineering preferred
8+ years medical device experience (or 6+ with M.S.)