שלח קורות חיים
This position conducts engineering activities and tasks in support of manufacturing requirements.
Key Responsibilities & Authorities:
•Develop design improvements from design freeze and during mass-production.
•Design, qualify, document and validate: Electronic assemblies, test fixtures and tools, release to production and service.
•Performs root causes analysis on equipment and manufacturing process issues.
•Support on-going production processes and equipment, train subcontractors & production line.
•Creating work and testing instructions, production and assembly instructions.
•Provides technical evaluation and implementation plan input to the Corrective Action/Preventive Action (CAPA) program.
•Construction and management of product DMR including BOM, SOP's and specs.
•Configuration management and Implementation of Engineering Changes.
•Components engineering, leading activities on obsolescence parts.
Note: The following are meant to be representative but not necessarily all inclusive of the duties and responsibilities for this position title.
BSc. Degree in Electronic Engineering.
Understanding and knowledge of relevant regulations and standards FDA QSR, ISO 13485, ISO 14971, MDD – Advantage.
At least five (3) years proven experience in design Engineering & Knowledge of PCB manufacturing and assembly line requirements.
Environments of multi-disciplinary products in Medical Device companies.
Prior experience with some of the following: PCB design, cables assembling and wiring design, Motors and control, EMC and safety compliance for medical device. Experience with medical-electrical standards IEC60601-1 & IEC60601-1-2.
Experience with off the shelf components such as: motors, optic sensors, LEDs
Experience with design of electronic test fixtures.
Experience with Process Validations and 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.
Job Specific Skills (Languages, SW, systems, etc.'):
Excellent communication skills, both verbal and written in English & Hebrew
Proven working experience on OrCAD Capture or equivalent schematic SW – at least 2 years' experience.
Office proficient, experience with PDM/PLM systems, Priority.
Other Requirements for the role:
Domestic and International Travel is required (10 %)
“Hands on”, Independent, quick learner and a team player.
For Applications please click on the following link: