Job Description/Responsibilities
Configuration management and Implementation of Engineering Changes/ECO.
Lead Engineering and R&D activities and tasks in support of configuration control and Change
control requirements.
Support and be involved in the NPI processes, Design Transfer, DFM, DFT.
Work closely with R&D, Operations and Product/Project managers.
Work with external parties – Electronic and Mechanical engineers, manufacturers, suppliers, and
subcontractors.
Responsibility for tracking information transfer to the ERP and PDM PLM systems.
Manage product BOM & DMR, maintain production files %28 Drawings, SOP’s, Specifications, Work
instructions, Test procedures, Labels, etc.%29.
Managing of CCB committees and support on-going Engineering change control process.
Qualifications
Mechanical Engineer/Industrial Engineer/ Biomedical Engineer.
At least 5 years experience in medical device companies.
Knowledge of medical Regulatory standards %28ISO13485, CFR21 820%29.
Experience in transferring multidisciplinary products from development to production and
managing of engineering changes – Mandatory.
Experience with ERP and PLM systems- Mandatory.
Working experience with Solidworks – Mandatory.
Experience with EPDM- Advantage.
Excellent communication skills, both verbal and written in English & Hebrew.
“Hands on”, Independendent, able to manage multiple tasks.
