Sr. Mechanical Engineer
Core
Design and develop innovative medical devices or components/subsystems for cardiac rhythm management to treat heart arrhythmias.
Role type
Senior IC mechanical engineer (medical devices)
Builds
Cardiac rhythm management devices and components
Domain
Healthcare / Medical Devices / Cardiology
Deliverable
production ML models | product features
Required skills
mechanical design, requirements specification, experimental/empirical/numerical analysis, risk mitigation, vendor management, pre-clinical/clinical testing support, design reviews, regulatory compliance (FDA/ISO), material selection (implant grade), project scheduling, design verification and validation, mentoring
Preferred skills
Class III medical device R&D, electromechanical device design, design controls/CAPA/process controls/risk management, Solidworks/Creo, Design for Six Sigma
Technologies
Solidworks, Creo, Six Sigma tools
Responsibilities
Design medical devices to meet user needs; establish requirements and specifications; evaluate designs using analysis; lead test method and model development; identify and mitigate project risks; work with vendors to obtain prototype parts; lead pre-clinical and support clinical testing; lead design reviews; maintain understanding of clinical environment and regulations; manage project schedules; make decisions on material usage; document and run design verification and validation testing; support Quality and Environmental Management Systems; mentor junior engineering team members
Seniority
Senior, hands-on IC with leadership