ICECURE JOB DESCRIPTION
IceCure Medical, an innovative and fast-growing medical device company and leader in the Cryoablation market, is looking for a talented Project Manager with previous R&D experience in the Medical Device field to join our R&D and Engineering team in Caesarea, Israel.
The Project Manager will report to the VP, R&D and Engineering. The work is done in a multidisciplinary environment: Mechanics, Software, Electronics with team collaboration of Clinical\Operations\Service\QA\RA fields.
The candidate will be responsible for managing key strategic projects – from project initiation to launching, including project planning, risk assessment, resource management, and timely communication of key milestones and deliverables. The projects may range from product development for commercial launches, clinical studies or advanced technology feasibility initiatives.
Roles & Responsibilities:
- Leading & coordinating the end-to-end activities of the cross-functional project development core team in the development and NPI of multidisciplinary capital equipment & disposable products.
- Planning and leading the product development activities from project initiation stage until product release. Developing a detailed project plan that is both holistic and detailed and takes into account the design control deliverables (all technical aspects) and other deliverables required for a clinical study or a commercial launch.
- Cross-functional project execution leadership including concept discussion, system design, design & technical meetings, V&V and qualification tests, program execution, clinical and pilot trials, and product field delivery.
- Initiate and lead the design reviews at the required stages of the project development process.
- Provide completion of project activities and project deliverables according to the project plan. Drive compliance/closure of regulatory and quality requirements before approving design control and NPI program milestones
- Take responsibility for scheduling regular project status update meetings and reviews with a cross-functional project team.
- Lead project activities after release to production and commercialization
- Manage local & overseas subcontractors in NPD & NPI phases.
- Bachelor’s Degree in Mechanical/Biomedical/System with minimum 3 years of experience in Project Management in a medical multidisciplinary technology company or equivalent.
- At least 7 years experience in the Medical Device field, developing medical multidisciplinary capital equipment and disposable units
- Demonstrated experience in product releases throughout the entire NPI cycle. Proven execution skills in meeting project goals with desired quality, performance, schedule & budget
- Familiarity with ISO13485, FDA, NMPA, PMDA and other regulatory standards
Skills and abilities:
- Strategic planner and thinker
- Excellent knowledge in R&D, engineering, program management and planning processes with experience in the Medical Device product lifecycle
- Strong written and oral communication skills
- Demonstrated problem solving ability and results orientated
- Experience in MS-Office, MS-Project, MS Planner – Must
- Experience in Solidworks, LabView, Imaging SW – Advantage
- Ability to effectively prioritize and execute tasks in a high-pressure environment
- Excellent human relations, independence, authority, readiness for strenuous work, proven ability to work across multiple tasks and interfaces. Strong teamwork skills
- Fluent in Hebrew and English. Additional languages are preferred
Please send CV to: