Creating the engineering entity in the company
Ramp up small scale production for supporting clinical trials
Improvement of the short-term manufacturing process
Sourcing for suppliers and planning improvements fitting for production
Build a manufacturing folder
Source and support for production line equipment
Managing subcontractors:
PCBA
Plastics
Assembly
Mass production testing equipment
Lead the regulations process of the process: Safety, EMC, Radio, sustainability etc.
Design and support the development of future products
Work with supply chain and procurement on BOM and logistics to support the clinical trial
Reports to VP R&D
Requirements
Electronics / mechanical engineer or similar degree
At least 5 years of experience in engineering
Experience with working with subcontractors: molders, PCB suppliers, regulations entity
Familiar with ISO13485
Experience in NPI for medical devices
Experience with NPI
Working experience with PCB testing automation
Design of electronics (design, schematics, working with editors) – advantage
Experience in working with fabric manufacturers – advantage
