Product Development Engineer
ICECURE JOB DESCRIPTION
IceCure Medical, an innovative and fast-growing medical device company and leader in the cryoablation market, is looking for a talented Product Development Engineer, to join the R&D department in Caesarea, Israel.
The work is done in a multidisciplinary environment: Mechanics, Software, Electronics with Clinical\Operations\Service\QA\RA teams’ collaboration.
Roles and Responsibilities:
- Work with the product development & other stakeholder teams to create detailed design specifications and testing plans.
- Collaborate & conduct meetings with customers to collect & analyze all requirements to prepare appropriate design strategies. Define end-to-end product workflow and product modes.
- Perform FT and analyze system performance. Responsibility for product LOG VAULT.
- 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 the risk management file to ensure successful regulatory approval of the new product across global markets.
- Responsible for defining system performance requirements and ensuring design implementation and verification of performance features.
- Develop novel system user interfaces and work procedures for product and clinic procedures.
- Conduct user testing, working in close collaboration with human factors and clinical engineering.
- Contribute actively to continuous process improvements.
- Carry out field testing and bench level testing.
- Effectively troubleshoot the systems associated with the LabVIEW program, including not only the software but other aspects such as the host PC, sensors, motors, pumps, electrical junctions, etc.
- Write technical documentation: specs, verification procedures, reports.
- Test prototypes and/or production systems according to safety, environment, electrical, software and essential performance specifications.
- Manage local & overseas subcontractors.
- · B.Sc. or M.Sc. in in Mechanical, or Biomedical Engineering with 3-5 years of experience.
Proven track record and ability developing and testing user interfaces products.
Experience in Mechanical\HW\SW and system design.
Experience 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 LabVIEW & Office applications. Solidworks – Optional.
Experience with GITHUB, SVN or other SW version control systems.
- Experience in Medical Device Design Control procedures & Software Development Life Cycle – Advantage
- Fluent in Hebrew and English. Additional languages are preferred.
Good project management skills.
Strong technical altitude.
Ability to effectively prioritize and execute tasks in a high-pressure
Excellent human relations, independence, authority, readiness for strenuous work, proven ability to work across multiple tasks and interfaces. Strong teamwork ability.
The company is located in Caesarea, Israel.