an innovative and fast-growing medical device company,
a leader in the Cryoablation market, is looking for an R&D System
Engineer, join the R&D department. The work is done in a multidisciplinary
environment: Mechanics, Software, Electronics with Clinical, OperationsServiceQARA
teams’ collaboration.
Roles & Responsibilities:
o Design Mechanical & Multidisciplinary modules from the initial concept to release as a part of R&D department, with reference to medical device standards, and focus on customers and business specifications.
o Point of contact for R&D subcontractor’s activities: DR’s, Integration & Implementation in company products.
o 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.
o Responsible for product integration, reliability, qualification, environmental and safety tests in external LAB and in-house. Perform FTA and detecting preferred system technical solutions.
o Create a system and modules design specifications, V&V protocols, transfer to production documentation %28DMRDHF%29 following procedural development of medical products %28Design Control%29.
o Support and cooperate with company departments %28Regulatory, Service, Manufacturing, Engineering, Quality, and Marketing%29, being responsible for their early involvement during system design processes. Preparation of Risk Analysis, FMEA for system elements according to QMS.
o Design Jigs & Fixtures for R&D and product manufacturing.
o Availability to travel abroad and domestically.
Job Requirements:
o B.Sc. or M.Sc. degree in MechanicalSystem Engineering
o Knowledge in Cryogenics – Preferred
o At least 2-5 years proven experience in Engineering environments of multidisciplinary products or medical devices.
o Experience with Machining, Design hydraulic & pneumatic elements, Sheetmetal, Injection molding, Extrusion, Electronic packaging
o SolidWorks – High-level expertise.
o Knowledge of standards and regulations: DIN, ASTM, ISO 13485, IEC 60601 CFR21, IEC 60601, UL, CE, etc.’
o Knowledge in DF’x %28AMCTS%29 methodology implementation – Preferred
o Knowledge in PMP & INCOSE methodology – Preferred
o Familiarity with other ERP, PLM, PDM tools – Preferred
o Excellent human relations, independence, authority, readiness for strenuous work, proven ability to work across multiple tasks and interfaces, Strong teamwork ability
o Fluent in Hebrew and English. Additional languages are preferred
