Job Title: V&V Engineer
Reports To: CTO
Microbot is seeking an experienced V&V engineer. The successful candidate will join a dynamic company and shall oversee leading all the System verification and validation activities that are required to release the system for production. The role includes close work with R&D (mechanics, electronics, and embedded S/W) to specify, execute and report the required tests and work with QA/RA for medical QMS compliance.
- Review specifications and technical design documents to provide timely and meaningful feedback
- Work closely with the project managers
- Define and lead the testing of a noble medical robotic system
- Design and define testing methods
- Manage V&V contractors and labs that perform regulatory and environmental tests
- Generate comprehensive V&V test plans, protocols, and reports with the ability to maintain and cross-reference it with Risk Analysis Matrix & Design Control documentation.
- Identify and track defects during testing
- Deeply collaboration with Clinical, QA and RA team
Support QA aspects of technology transfer of developed manufacturing processes and new product development from R&D to manufacturing environment (Process Validation Equipment verification, TMV, Quality Acceptance Criteria, ATP)
Experience and Capabilities:
- BSc degree in System, Mechanical, Electrical or Biomedical engineering or related filed
- Proven experience of leading and conducting V&V activities of Medical devices for at least 5 years, including writing, and executing test plans and protocols for medical devices with strong emphasis on quality assurance and problem solving
- Experience from multi-disciplinary medical device companies
- Formal and practical knowledge of testing methodologies
- Excellent documentation skills and ability to communicate effectively at all levels of the organization.
- Team player
- Excellent written and verbal communication skills
- Fluent in English (reading writing)
- Highly organized
- Familiar with Medical Device Quality Systems, ISO 13485 & CFR21 part 820, Design Control processes, Design and Development Usability procedures. Experience with the environment, safety, biocompatibility, and essential performance tests (e.g. IEC 60601)
- Experience with medical robotic system “Usability Testing” as an advance.