V&V and failure analysis engineer:ICECURE JOB DESCRIPTION
IceCure Medical, an innovative and fast-growing medical device company and leader in the Cryoablation market, is looking for a V&V and Failure Analysis Engineer to join our team in Caesarea, Israel.
Roles and Responsibilities
- Review specifications and technical design documents to provide timely and meaningful feedback for Engineering Verification & Validation activities.
- Ownership & Maintain the company Verification, Validation & Process Validation infrastructure (SOP, Forms, SW tools, Jigs, Simulators).
- Create detailed, comprehensive and well-structured V&V test protocols and reports, with the ability to maintain and cross-reference it with Risk Analysis Matrix & Design Control documentation.
- Define & Execute the Usability & Ergonomic Verification Test protocols.
- Develop, apply & maintain test methods, equipment and instruments for the medical device throughout all development and production stages of the product to meet user needs & product requirements.
- Being involved in the reliability and integration tests for prototypes and products.
- Developed manufacturing process validation activities for sustain & NPI projects (IQ\OQ\PQ, Validation Plans, Sample size, ATP, Testing forms and Documentation).
- Maintain relevant chapters of DHF & DMR.
- Development and implementation of methodologies for collecting and analyzing field failure data and determining root cause of field failures (FTA, LOG’s investigation, SPR, service Failure analysis, etc’).
- Leading company efforts to eliminate life field failures in products.
- Coordinating failure analysis with other disciplines as necessary to lead to determination of root cause.
- Ensuring corrective actions are implemented in manufacturing to prevent recurrence of failure.
- Incorporating automation and improvement of failure analysis process.
- BA/BSc. Degree in Mechanical \ Biomedical or equivalent practical experience.
- 1-2 Years of proven Verification & Process Validation experience in medical device industry with a strong emphasis on problem solving, along with written and verbal skills.
- Root cause analysis methodologies and six-sigma methodologies – Optional.
- Knowledge and experience with Medical Device Quality Systems, ISO 13485, FDA.
- Knowledge and experience with environment, safety, bio-compatibility, sterility and essential performance tests (IEC 60601, EN 61508, ISO 10993-5, ISO 11135, etc.).
- LabView & MATLAB Experience. Full proficiency in MS-OFFICE.
- Solidworks, ERP\PDM – optional.
- Strong technical orientation for understanding multi-disciplined systems.
- Good documentation skills and ability to communicate effectively at all levels of the organization.
- Can conform to shifting priorities, demands and timelines through analytical and problem-solving capabilities. Ability to effectively prioritize and execute tasks in a high-pressure environment.
- Multi-tasker, independent, punctual and accurate with excellent organizational skills, Team oriented, collaborative, good personal relationships.
- Excellent skills in English language are required (verbal and written communication).
- Full-time role based in Caesarea, Israel.
Send CV to : Naum@icecure-medical.com, Elisabeth@icecure-medical.com , info@icecure-medical