Sustain System Engineer

IceCure Medical, an innovative and fast-growing medical device company leader in the Cryoablation market, is looking for Sustain System Engineer to join the Engineering Team. The work is done in a multidisciplinary environment: Mechanics, Software, and Electronics with Clinical, Operations\Service\QA\RA teams’ collaboration.

Job description and responsibilities

• Responsible for product integration, reliability, qualification, environmental, and safety tests in external LAB and in-house. Perform FTA and detect preferred system technical solutions.
• Leading and maintaining product configuration following procedural development of medical products (Design Control): Design History Files (DHF), Device Master Record (DMR), (RTM) Requirements Traceability Matrix and their change approval.
• Creating \ reviewing & maintaining a wide range of Engineering documentation (Assy WI, IQ\OQ\PQ,V&V protocols, Acceptance Criteria, Procedures, Templates, and Forms) with QA & Operations Departments' deep cooperation.
• Lead System aspects in products portfolio: top-level architecture, modern technologies implementation, define performance goals and tests, serviceability, interfaces specs, design to assembly and cost, human factors design, with reference to medical device standards, and focus on customers and business specifications.
• Execution of engineering investigations and LOG analysis as part of NCRs, CAPAs, and Customer complaints.
• Support and cooperate with company departments (Regulatory, Service, Manufacturing, Engineering, Quality, and Marketing), being responsible for their early involvement during system design processes.
• Leading and maintaining Risk management file and FMEA for system elements according to QMS.
• Responsible for assessing risks that arise from complaints, ECOs, CAPAs, etc. Vs. risk management file.
• Involved in cost reduction \ improvement design & process activities.
• Availability to travel abroad and domestically.

Education and Experience

• B.Sc. or M.Sc. degree in Medical\Mechanical\System Engineering.
• Knowledge in Cryogenics – Preferred.
• At least 2 years of proven experience in engineering environments for multidisciplinary products or medical devices.
• Interpersonal skills and excellent teamwork - the ability to meet technical and human challenges.
• Experience in medical device quality systems, specifically Risk management file and Design Inputs.
• Experience resolving complex system issues and being “hands-on” when needed.
• Good documentation skills.
• Experience in MS Office, MS Project, and MS Planner – Must.
• Experience in Solidworks, LabView, ERP, PLM, and PDM tools – Advantage.
• Fluent in Hebrew and English.

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• Send CV to Mail: [email protected] & [email protected]