Department: Device Engineering
Primary purpose and function of this position:
Support production lines for medical devices in aspects of HW engineering from design for manufacturability, through NPI %28Transfer from R&D to commercial production%29 to sustaining of the lines and ongoing support.
Major duties and responsibilities:
1. Design for manufacturability:
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 electrical aspects of commerical 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 transfer to production to subcontractors:
3.1. Owner of the validation of the electrical aspects of commercial manufacturing process.
3.2. Approve operation/maintenance procedures for commertial manufacturing electrical processes/tools/tests.
3.3. Work with R&D and QA to complete the Transfer to production design phase including formalizing the DMR %28Device Master Record%29.
4. Be the SME for sustaining activities.
5. Lead scale up activities of commerical lines.
6. Changes to commercial lines %28improvements, failure investigation, change location, duplication, end of life of components%29:
6.1. SME in failure investigation and melfunctions in production line that impact the product function/quality.
Requirements:
1. Fluent English verbal and writing.
2. Experience in NPI of medical devices.
3. Experianced in managing/colaboration with sub-contractors.
4. Technial skils 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 %28optional%29.
5. Well experianced with risk assessment evaluations, pFMEA documentation and implementation.
6. Well experianced with equipment qualification processes, Instalation Qualification %28IQ%29, Operation Qualification %28OQ%29, Process qualification %28PQ%29.
7. Quick learner, Team player, height level orgenized abilities, analytical thinking, detail oriented.
8. Experience with FDA QSR and ISO 13485 medical device regulations.
9. Experience with CAD systems and PLM systems.
Education and Knowledge Requirements:
· Electrinical Engineer/ Practical Engineer with At least 10 years of experience in in the Medical devices industry.
· Knowledge with document control systems and PLM systems.
Reports To: Device Engineering Director
Note: Any equivalent combination of education, training and/or experience that fulfills the requirements of the position may be considered.
Travel Requirements: 15%. International Travel required.
