Device Production Support Hardware Engineer
Device Production Support Hardware Engineer
29/06/2025תיאור
Support production lines for medical devices in aspects of HW engineering from design for manufacturability, through NPI (Transfer from R&D to commercial production) 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 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 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 commercial 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 (Device Master Record).
4. Be the SME for sustaining activities.
5. Lead scale up activities of commercial lines.
6. Changes to commercial lines (improvements, failure investigation, change location, duplication, end of life of components):
6.1. SME in failure investigation and malfunctions in production line that impact the product function/quality.
דרישות התפקיד
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.
Education and Knowledge Requirements:
· Electronical 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.
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