NPI Device Production Support Engineer
מעבר למשרות נוספות המימד השלישי פתרונות משאבי אנוש בע
פורסם לפני 11 ימים
- רחובות
- משרה מלאה
- 30,000 ₪ - 32,000 ₪
פרטי מגייס/ת המשרה:
תיאור המשרה:
Support production lines for medical devices in aspects of Mechanical 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:
Design for manufacturability:
Work closely with the R&D and System engineering team to provide inputs for Design for manufacturability.
Participate in Design Reviews.
Define manufacturing processes:
Define, in collaboration with R&D, the mechanical aspects of commerical manufacturing processes of the device and its testing.
Define, build and qualify the mechanical aspects of the engineering lines to provide samples for testing during the development process.
SME in mechanicval aspects for pFMEAs and their integration into other risk deliverables.
Mechanical aspects of transfer to production to subcontractors:
Owner of the validation of the mechanical aspects of commercial manufacturing process.
Major duties and responsibilities:
Design for manufacturability:
Work closely with the R&D and System engineering team to provide inputs for Design for manufacturability.
Participate in Design Reviews.
Define manufacturing processes:
Define, in collaboration with R&D, the mechanical aspects of commerical manufacturing processes of the device and its testing.
Define, build and qualify the mechanical aspects of the engineering lines to provide samples for testing during the development process.
SME in mechanicval aspects for pFMEAs and their integration into other risk deliverables.
Mechanical aspects of transfer to production to subcontractors:
Owner of the validation of the mechanical aspects of commercial manufacturing process.
דרישות המשרה:
Fluent English verbal and writing.
Experience in NPI of medical devices.
Experianced in managing/colaboration with sub-contractors.
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.
Well experianced with risk assessment evaluations, pFMEA documentation and implementation.
Well experianced with equipment qualification processes, Instalation Qualification (IQ), Operation Qualification (OQ), Process qualification (PQ).
Quick learner, Team player, height level orgenized abilities.
Experience with FDA QSR and ISO 13485 medical device regulations.
Experience with CAD systems.
Education and Knowledge Requirements:
· Mechanical Engineer with At least 10 years of experience in in the Medical devices industry.
· Experience in PCB assmelby an advantage.
· Knowledge with document control systems and PLM systems.
Experience in NPI of medical devices.
Experianced in managing/colaboration with sub-contractors.
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.
Well experianced with risk assessment evaluations, pFMEA documentation and implementation.
Well experianced with equipment qualification processes, Instalation Qualification (IQ), Operation Qualification (OQ), Process qualification (PQ).
Quick learner, Team player, height level orgenized abilities.
Experience with FDA QSR and ISO 13485 medical device regulations.
Experience with CAD systems.
Education and Knowledge Requirements:
· Mechanical Engineer with At least 10 years of experience in in the Medical devices industry.
· Experience in PCB assmelby an advantage.
· Knowledge with document control systems and PLM systems.
מאפייני משרה:
עבודה היברידית
מעבר למשרות דומות בתחומים:
משרה מספר 8988070
metapel
על החברה:
המימד השלישי פתרונות משאבי אנוש בע
גודל חברה: 11-50
תעשייה: משאבי אנוש
חב’ המימד השלישי מתמחה בניהול תהליכי גיוס עבור ארגונים המחפשים פתרונות יצירתיים ולא קונבנציונליים.
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