Product Development Engineer

IceCure Medical, an innovative and fast-growing medical device company and leader in the Cryoablation market, is looking for an experienced and motivated Product Development Engineer to join our Research and Development team.

Are you passionate about innovation and transforming ideas into reality?
Do you thrive in a collaborative environment and possess a knack for problem-solving?
If so, we’d love for you to join our team as an R&D Product Development Engineer!

Roles & Responsibilities:

• Work with Product Development and other stakeholders’ teams to create detailed design specifications and testing plans. Collaborate with customers and hold meetings to collect and analyze all requirements to prepare appropriate design strategies.
• Define end-to-end product workflow and product modes.
• Perform FTA, responsible for SW\HW tools to make system performance analysis.
• Lead product integration activities (SW, Mech, Elect.) to validate customer requirements.
• Conceptualize, design, prototype, test, and ship system or module features along with our product and engineering teams.
• Contribute to risk management file to ensure successful regulatory approval of the new product across our global markets.
• Responsible for defining System Performance requirements and ensuring design implementation and verification of performance features.
• Develop novel system user interfaces and working procedures for product and clinic procedures.
• Conduct product human factors & usability validation activities in collaboration with RA and clinical engineering.
• Carry out field testing and bench-level testing.
• Effectively troubleshoot the systems associated with the LabVIEW program, including the software and other aspects such as the host PC, sensors, motors, pumps, electrical junctions, etc.
• Write technical documentation: specs, verification procedures, reports.
• Lead disposable and reusable product validations such as sterilization, biocompatibility, cleanability, shelf life, safety, and essential performance specifications.
• Manage local & overseas subcontractors.

Skills and Experience

• B.Sc. or M.Sc. in Mechanical, or Biomedical Engineering with 3-5 years of experience in medical device design and control procedures.
• Proven track record and ability to develop and test user interface products.
• Proven track record and ability of disposable product validations.
• Comfortable working across multiple disciplines (electrical, software, controls, human factors, clinical engineering).
• Experience and knowledge in Quality and Regulatory aspects (ISO 14791, IEC60601, ISO 13485, CE, FDA).
• Experience in Solidworks, LabVIEW, MATLAB, Payton & MS-Office.
• Experience with SolidPDM, GITHUB, SVN, or other SW version control systems – Optional.
• Good project management skills (MS Teams, MS-Project).
• Strong technical altitude.

General Requirements

• Responsible for creating workflows and work methods in the Probe products.
• Synchronize between the system process & control design.
• Responsible for main documentation modules.
• Manage several sub-contractors in parallel.
• Self-driven, Independent and well-organized.
• Fluent in Hebrew and English. Additional languages are preferred.

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