Verification & Validation Manager

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 in new 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. You will 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 of ophthalmic robotic surgery.

• Degree in Biomedical, Mechanical, Electrical, or other relevant engineering degrees.
• 8+ years of experience as a V&V and/or SQA 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.
• Knowledge of testing methodologies (capital equipment and single-use devices).
• 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 (e.g. IEC 60601).
• 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.