מהנדס/ת מערכת לחברת מדיקל מובילה קיסריה 225941
מהנדס/ת מערכת לחברת מדיקל מובילה קיסריה 225941
17/05/2023Develop Mechanical & Multidisciplinary modules from the initial concept to release as a part of the R&D department, with reference to medical device standards.
Create system and modules design specifications and requirements, translating user needs to technical requirements.
Create design and transfer to production documentation (DHF\DMR) following procedural development of medical products (Design Control).
Responsible for creating and maintaining RMF (Risk Management File).
Point of contact for R&D subcontractor’s activities: DR’s, Integration & Implementation in company products.Responsible for creating and maintaining RMF (Risk Management File).
System aspects design in products portfolio: top-level architecture, new technologies implementation, define performance goals and tests, serviceability, interfaces specs, design to assembly and cost, human factors design.
Responsible for product integration, reliability, qualification, environmental and safety tests in external LAB and in-house.
Perform RCA (Root Cause Analysis) and drive outcoming system technical solutions to implementation through tests and data.
Technical Leadership across project scope and the various company functions and resources.
Support and cooperate with company departments (Regulatory, Service, Manufacturing, Engineering, Quality, and Marketing), being responsible for their early involvement during system design processes. Preparation of Risk Analysis and FMEA for system elements according to QMS.
Lead system process validation activities.
Availability to travel abroad and domestically.
:Education and Experience
B.Sc. or M.Sc. degree in Mechanical\System Engineering.
At least 4 years of proven experience in Engineering environments of multidisciplinary products in medical devices - must
Excellent design and development skills, from parts and sub-modules to final product and production support, proficient in the full life cycle of a product, including requirements generation, conceptual design, DR’s, Experiments, Design Transfer Plans, etc.
Excellent troubleshooting skills and drive to bring best-in-class solutions
Experience with Machining, designing hydraulic & pneumatic elements, Sheetmetal.
Experience with Injection molding, Extrusion, Electronic packaging, and Sterilization processes – Preferred.
SolidWorks & PDM - High-level expertise
Knowledge of standards and regulations: DIN, ASTM, ISO 13485, IEC 60601 CFR21, IEC 60601, UL, CE, etc.’
Knowledge in Cryogenics – Preferred.
Knowledge in DF’x (A\M\C\T\S) methodology implementation – Preferred.
Knowledge in PMP & INCOSE methodology – Preferred.
* משרה מס׳ #225941 מיועדת לגברים ונשים כאחד
משרה זו סגורה ולא ניתן לשלוח אליה קורות חיים.