שלח קורות חיים
Develop design improvements from design freeze & during mass-production.
Design, qualify, document & validate: assembly & test fixtures/Jigs & tools, release to production & service.
Performs root causes analysis on equipment & manufacturing process issues.
Support production processes and equipment, train subcontractors & production line.
Creating work & testing instructions, production & assembly instructions.
Provides technical evaluation & implementation plan input to the CAPA program.
Construct & manage of product DMR including BOM, SOP's, Mechanical & electrical specs.
Configuration management & Implementation of Engineering Changes/ECO.
BSc.in Mechanical Engineering.
Knowledge of relevant regulations & standards FDA QSR, ISO 13485, ISO 14971, MDD
5+ years experience in design Engineering & manufacturing environments of multi-disciplinary products in Medical Device.
Prior experience with some of the following: complex machined parts, sheet metal Pneumatics, Motors, plastics, cable assemblies, PCBA.
Experience with design of Jigs, fixtures & Packaging.
Experience with Process Validations & qualification of equipment IQ/OQ/PQ, pFMEA.
Experience with process optimization/improvement, lean manufacturing, 5S, Root cause analysis & CAPA.
Experience with design of surgical tools – Advantage.
Proven experience with Solidworks, PDM/PLM systems, Priority – Mandatory
Please send you CV to: firstname.lastname@example.org
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