Product Development Engineer
Core
Develop minimally invasive medical devices, specifically catheter-based endovascular technologies, from concept through manufacturing.
Role type
Senior Product Development Engineer (Medical Devices)
Builds
Catheter-based endovascular delivery systems and related medical device components
Domain
Medical Technology / Endovascular Devices
Required skills
Mechanical/Biomedical Engineering, Product Lifecycle Management, Design Control, Risk Management (ISO 14971), Regulatory Compliance (ISO 13485), Supplier Management, Design Verification & Validation, Technical Documentation, Root-Cause Analysis, Manufacturing Transfer
Preferred skills
Minimally invasive device experience, DFM/DFA knowledge, Contract manufacturer collaboration, External test lab management
Technologies
CAD, BOM management tools, Design control software, Testing equipment
Responsibilities
Lead product development, design changes, and new variants; Execute engineering testing and design verification; Manage design documentation and technical files; Coordinate with suppliers and manufacturing partners; Support design transfer and implementation; Troubleshoot product issues and lead root-cause analysis.
Seniority
Senior, hands-on IC
