Engineering Project Lead

7 days ago

Caesarea, Haifa, Israel IceCure Medical Full time ₪80,000 - ₪120,000 per year

Reports to:
Director of Engineering

Department
: R&D and Engineering

Job Description and Responsibilities

  • Lead, Plan & Coordinate end-to-end cross-functional activities of products in sustain & NPI phase.
  • Develop a detailed project plan that is both holistic and detailed and considers design control deliverables (all technical aspects) and other deliverables required for a clinical study or commercial/regulatory launch.
  • Coordinate regular project status update meetings and reviews with a cross-functional project team. Provide completion of project activities and project deliverables according to the project plan.
  • Responsible for product integration, reliability, qualification, environmental, and safety tests in external LAB and in-house. Support products DHF & DMR lifecycle processes.
  • Cross-functional project execution leadership, including concept discussion, System design, Design & Technical meetings, V&V and qualification tests, clinical and pilot trials, and product field delivery.
  • Provide services to Clinical\Service\QA\RA\Operation\BD departments on Service calls, CC, CAPA, Wavers, regulatory submissions, etc.
  • Initiate and lead the design reviews at the required stages of the project process.
  • Generate, review, and provide feedback on designs, as well as product and regulatory documentation.
  • Execution of engineering investigations and LOG analysis as part of NCRs, CAPA, and Customer complaints.
  • Lead and maintain the Risk management file, Risk assessment, and FMEA for system elements according to QMS.
  • Responsible for assessing risks arising from complaints, ECOs, CAPAs, etc., in the risk management file.

Education and Experience

  • Bachelor's Degree within an appropriate Mechanical/Biomedical/System discipline with Project Management experience in a medical multidisciplinary technology company or equivalent.
  • Experience of at least 3-7 years in medical devices with development of medical multidisciplinary capital equipment and disposable units.
  • Strategic planner and thinker
  • Excellent knowledge in R&D, engineering, program management, and planning processes, and experience with the medical device product lifecycle.
  • Demonstrated experience in product releases throughout the entire NPI cycle. Proven execution skills at meeting project goals with desired quality, performance, schedule & budget
  • Strong written and oral communication skills
  • Demonstrated problem-solving ability and results orientation.
  • Familiarity with ISO13485, FDA, NMPA, PMDA, and other regulatory standards
  • Experience in MS-Office, MS-Project, MS Planner – Must
  • Experience in Solid works, LabView, Imaging SW – Advantage

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