Who are we lookinq for?
Passionate people who want to make a difference drive our culture – our team members are grounded in integrity, have a strong capacity to learn, have the energy to get things done, and bring diverse, real-world experiences to help us think innew ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.
We are looking for a candidate with the ability to thrive in an environment with complex software and hardware designs, take ownership and be responsible for testing the performance and functionality of a novel ophthalmic robotic platform. Youwill join a growing team and take part in shaping the future of the verification team and processes. This is an ideal opportunity for someone who is motivated and passionate to make an impact in creating the next generation ofophthalmic robotic surgery.
Responsibilities
● Build and lead V&V group including recruitment, training, and mentoring V&V engineers
● Define V&V processes and methods including ongoing system testing activities and new feature / version release testing. Define processes and implement activities
● Take active participation in the R&D effort providing inputs on the design from the V&V process perspective
● Build the company%27s V&V test plan, protocols, and reports
● Responsibility for the system testing of SW, HW, and mechanics.
● Maintain traceability between the relevant design control documentation
● Ensure that the test article %28hardware/software%29, test facility, support personnel, and test procedures are ready and maintained towards and during the V&V stages
● Establish the company%27s process validation infrastructure
● Supporting system engineering activities, such as integration and requirements approval
Qualifications
● Degree in Biomedical, Mechanical, Electrical, or other relevant engineering degrees
● 8+ years of experience as a V&V Engineer
● 5+ years of experience as a V&V Manager or equivalent managerial experience
● Experience with medical device regulations and standards
● Experience with technologically complex multidisciplinary systems including HW and SW experience at multi-disciplinary medical device companies
● Knowledge of testing methodologies %28capital equipment and single-use devices%29
● Strong knowledge of software QA methodologies, tools, and processes
● Excellent understanding of 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 %28e.g. IEC 606011 %29
● Good organizational skills and strong written and verbal communication in English
● Good documentation skills and ability to communicate effectively at all levels of the organization
● Ability to self-manage, lead technically and communicate effectively
