Job Title: System V&V Engineer
Reports To: CTO
About Microbot Medical:
Microbot Medical is a dynamic, publicly traded, global, medical robotic device startup company that is committed to improving endoluminal surgery with our LIBERTY ® Robotic System. The headquarters are in Yoqneam, Israel and our US office is in Boston, MA.
Working at Microbot Medical will enable you to grow your career while accomplishing things you never could have imagined. Our team is devoted to improving the quality of life for patients worldwide by advancing micro-robotic luminal technologies. If you have passion for innovation, a strong drive to succeed and a can-do attitude, don`t miss this opportunity.
Microbot is seeking an experienced System V&V engineer. The successful candidate shall be responsible for establishing and leading the System verification and validation activities in preparation for production. The System V&V Engineer is part of the R&D team and will work with mechanics, electronics, and embedded S/W to specify, execute, and report the required tests, while working with QA/RA to establish medical QMS compliance. The System V&V Engineer will play a key role in the design.
- Review specifications and technical design documents to provide timely and meaningful feedback
- 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 collaborate 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)
- 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 3 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
- Familiarity 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 RF wireless testing- advantage
- Experience with medical robotic system “Usability Testing” as an advance.