Support medical device production lines in aspects of HW engineering, from design for manufacturability through NPI (Transfer from R D to commercial production) to sustaining the lines and ongoing support.
1. Design for manufacturability.
2. Define manufacturing processes
2.1. Define, in collaboration with R D, the electrical aspects of commercial manufacturing processes of the device and its testing. 2.2. Define, build, and qualify the electrical aspects of the engineering lines to provide samples for testing during the development process. 2.3. SME in electrical aspects for pFMEAs and their integration into other risk deliverables.
3. Electrical aspects of NPI to subcontractors. 4. Be the SME for sustaining activities. 5. Lead scale-up activities of commercial lines. Changes to commercial lines (improvements, failure investigation, change location,duplication,end of life of components
1. Design for manufacturability.
2. Define manufacturing processes
2.1. Define, in collaboration with R D, the electrical aspects of commercial manufacturing processes of the device and its testing. 2.2. Define, build, and qualify the electrical aspects of the engineering lines to provide samples for testing during the development process. 2.3. SME in electrical aspects for pFMEAs and their integration into other risk deliverables.
3. Electrical aspects of NPI to subcontractors. 4. Be the SME for sustaining activities. 5. Lead scale-up activities of commercial lines. Changes to commercial lines (improvements, failure investigation, change location,duplication,end of life of components
Requirements:
1. Fluent English verbal and writing.
2. Experience in NPI of medical devices.
3. Experienced in managing/collaboration with sub-contractors.
4. Technical skills electronics:
o Reading Electrical schematics.
o Review of PCB/PCBA manufacturing files.
o Define evaluate TEST equipment.
o Maintain electrical BOM lifecycle.
o TEST equipment code programming knowledge (optional).
5. Well experienced with risk assessment evaluations, pFMEA documentation and implementation.
6. Well experienced with equipment qualification processes, Installation Qualification (IQ), Operation Qualification (OQ), Process qualification (PQ).
7. Quick learner, Team player, height level organized abilities, analytical thinking, detail oriented.
8. Experience with FDA QSR and ISO 13485 medical device regulations.
9. Experience with CAD systems and PLM systems.
Travel Requirements: 15%. International Travel required.
1. Fluent English verbal and writing.
2. Experience in NPI of medical devices.
3. Experienced in managing/collaboration with sub-contractors.
4. Technical skills electronics:
o Reading Electrical schematics.
o Review of PCB/PCBA manufacturing files.
o Define evaluate TEST equipment.
o Maintain electrical BOM lifecycle.
o TEST equipment code programming knowledge (optional).
5. Well experienced with risk assessment evaluations, pFMEA documentation and implementation.
6. Well experienced with equipment qualification processes, Installation Qualification (IQ), Operation Qualification (OQ), Process qualification (PQ).
7. Quick learner, Team player, height level organized abilities, analytical thinking, detail oriented.
8. Experience with FDA QSR and ISO 13485 medical device regulations.
9. Experience with CAD systems and PLM systems.
Travel Requirements: 15%. International Travel required.
This position is open to all candidates.
