As a V&V Engineer you will be a part of a multidisciplinary team (Mechanical, Clinical, QA, RA) responsible for Research & Development of new
and current Cardiovascular innovative products. The role involves supporting the overall product life cycle from high level initial feasibility studies to post design freeze modifications. You will be planning and performing V&V tests for highly complex mechanical medical devices. We are looking for an ‘Hands-On’ energetic and dynamic person, with high technical skills, teamwork and creative problem solving. Together, we design and deliver high quality innovative medical devices intended to improve patient outcomes and the quality-of-life patients around the world.
Responsibilities :
· Ownership of project’s high level test plans (VnVMP), ECOs and sustain
· Define test methods and develop verification and validation tests
· Create detailed, comprehensive, and well-structured V&V test protocols, and reports derived from system requirements
· Hands-on, execution of verification and validation testing from proof of concept to design freeze
· Identify, record, document, and track failures during testing at all stages of design and system verification and validation
· Plan and arrange the labor, schedules, equipment, and internal and external laboratories required for testing and evaluating of medical
industry standards
· Preform and support statistical depth analysis of test results
· Responsible for coverage and traceability of tests to product requirements
· Interact closely with internal R&D Engineers and global external stack holders in China and EU
· Supports QA and RA aspects of technology transfer of developed manufacturing processes and new product development from R&D to manufacturing environment
· Support regulatory submissions and audits (USA, EU, China)
· Actively participate in the Design Change process to ensure the proposed changes to the products are systemically and thoroughly analyzed and assessed Support Engineering with customer complaint investigations (Root Cause Analysis)
Must-have Education, Experience and Skills:
· BSc. or higher in Mechanical, Biomedical Engineering (or equivalent)
· Minimum of 5 years’ experience in class II (or higher) medical device R&D, with a minimum of 3 years’ experience as a V&V Engineer
· Practical experience of complex testing and statistical analysis methodologies
· Demonstrated experience with working under relevant regulations and standards: FDA QSR, ISO-13485, MDD (MDR) – with a focus on Design Controls
· Experience with mechanical, sterilization, shelf-life and biocompatibility testing
· Deep understanding of Medical Device development standards such as: ISO-10933, ISO-14971, ISO-11607, ISO-11737, ISO-11135
· Ability to communicate in written and verbal English
Advantage Qualifications:
· Experience as an engineer in the Cardiovascular – Structural Heart field (procedures & delivery systems) – high advantage
· MSc. in relevant engineering field – advantage
· Experience with R&D of class III medical device – advantage
· Experience with Usability requirements and testing (ISO-62366) – advantage
