Major duties and responsibilities:
1. Design for manufacturabilit
1.1. Work closely with the R&D and System engineering team to provide inputs for Design for manufacturability.
1.2. Participate in Design Reviews.
2. Define manufacturing processes
2.1. Define, in collaboration with R&D, the manufacturing processes of the device (Mechanical, Electrical, SW).
2.2. Define, build and qualify engineering manufacturing lines to provide R&D samples for R&D, Clinical, HF, Verification.
2.3. Create and manage pFMEA.
3. Commercial manufacturing process
3.1. Define, build and validate commercial manufacturing process.
3.2. Define and write operation/maintenance procedures for commertial manufacturing processes/tools.
3.3. Work with R&D and QA to complete the Transfer to production design phase including formalizing the DMR (Device Master Record).
3.4. Lead scale up activities of commerical lines.
Requirements
1. Fluent English verbal and writing.
2. Experience in NPI of medical devices.
3. Experianced in managing/colaboration with sub-contractors.
4. Well experianced with automated manufacturing equipment:
o Automatic feeding of components, e.g: Bowl feeders linear feeders.
o Heigh rate automated assembly equipmentof plastic rigid and soft parts, 20 – 40 pcs/min.
5. Well experianced with risk assessment evaluations, pFMEA documentation and implementation.
6. Well experianced with equipment qualification processes, Instalation Qualification (IQ), Operation Qualification (OQ), Process qualification (PQ).
7. Quick learner, Team player, height level orgenized abilities.
8. Experience with FDA QSR and ISO 13485 medical device regulations.
9. Experience with CAD systems.
Education and Knowledge Requirements:
· Mechanical Engineer with At least 5 to 10 years of experience in in the Medical devices industry.
· Experience in Electrical engineering, PCB assmelby an advantage.
· Knowledge with document control systems and PLM systems.
Note: Any equivalent combination of education, training and/or experience that fulfills the requirements of the position may be considered.
Travel Requirements: 30%. International Travel required.
