Responsibilities:
Lead NPI process and deliverables including DFx process for new products.
Responsible for Product and Production Files and maintaining products DMR and DHR
Engineering BOM Management and components Engineering.
Write Work Instructions and technical specifications
Define and write process validation and lead FAIs
Responsible for Configuration Control and leading Engineering Changes.
Lead products technical regulatory testing (CE, FCC, Safety).
PLM ECO Administrator
Requirements:
BSc EE or ME
Experience of minimum 5 years as a Product/Production Engineering Manager in a multidisciplinary technologies company.
Familiar with FDA QMS and ISO13485 Requirements.
Work experience with medical devices company is a big plus.
Vast knowledge with PLM systems.
Experience with Arena PLM is a plus
Proven experience in leading products transfer from R&D to volume production
Work experience with full turnkey Contract Manufacturers.
Vast knowledge with PCB and PCBA technologies.
Experience with Opto-mechanics Assy and testing – Advantage.
Excellent verbal and writing communication skills.
Well organized, self-driven and hands-on person with high degree of servicing attitude.
Languages: Fluent Hebrew and English.