The V&V Director will be in charge of leading all the verification and validation activities, for clinical and HW/System, required to release the system/product to production. The role will include working with R&D departments (mechanics, embedded, electronics, SW, etc) to specify execute and report all the tests required, working with QA\RA for medical QMS compliance.
In this role, you will…
- Lead HW V&V teams, for testing dental scanner system.
- Lead Clinical Validation team for validating new clinical features presented to the doctors.
- Lead Continuous Reliability team, leading all reliability and aging tests for the system
- Manage V&V contractors, for leading various short-term V&V activities.
- Work with external labs (Carmel, SII, Aminolab) – performing regulatory & environmental tests.
In this role, you’ll need …
- Bachelor’s degree in Systems Engineering, Mechanical Engineering, Electrical Engineering, Biomedical Engineering or related field.
- Professional experience (at least 10 years) leading or supporting product Verification and Validation teams.
- At least 8 years of proven experience with management large groups, min. 30 people.
- Experience from multi-disciplinary companies, preferred medical device industry.
- Working knowledge of regulatory standards applicable to design of medical devices, including FDA QSR 21 CFR 820, ISO 13845, ISO 14971 and IEC 60601.
- Proficiency with statistical techniques including familiarity with Gage R&R, Reliability, analysis of variance (ANOVA) and design of experiment (DOE) methodologies highly desired.
- Strong project management skills, ability to build detailed plan.
- Strong technical skills- capability of taking requirements to detailed spec, assisting the team to define the detailed tests.
- Experience working with Medical QA QMS, having design controls expertise.
- Experience solving problems, provides detailed insight and constructive criticism in complex situations, and foresees problems along with potential solutions.
- Experience with implementing tests through a structured, phase-gated product development process.
- Experience with designing best practices, including design for reliability and testability, expertise in common risk management techniques.