Lead NPIprocess and deliverables includingDFx 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 echnologies company.
. Familiar with FDA QMS and ISO13485Requirements. 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.