Description
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.
Who we are
We are here to improve lives by restoring sight worldwide by a robotic platform for vision saving surgery. Our company will improve the way ophthalmic surgery is delivered to vision impaired individuals now and for decades to come.
We are rapidly growing, funded by leading international VCs, and are looking to expand our small, motivated, multi-disciplinary and phenomenal team. Joining us is an opportunity to work towards saving vision across the globe, collaborating with others to realize a dream, and tackle an enormous challenge that will help drive your career forward.
Responsibilities
- Build and lead V&V and SQA teams including recruitment, training, and mentoring engineers and testers.
- Define V&V and SQA processes and methods including ongoing system testing activities and new versions release testing.
- Take active participation in the R&D effort providing inputs on the design from the V&V process perspective.
- Develop and manage verification and validation plans, including test protocols, procedures, and acceptance criteria.
- Oversee the execution of V&V activities, ensuring thorough testing of hardware, software, and integrated systems.
- Maintain traceability between the relevant design control documentation.
- Ensure that the test article (hardware/software), test facility, support personnel, and test procedures are ready and maintained towards and during the V&V stages.
- Ensure software testing methodologies (e.g., unit, integration, system, and acceptance testing) are consistent with industry’s best practices.
- Plan and allocate resources, including personnel, equipment, and budget, for V&V activities.
Requirements
- 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.
Skills and Competencies
None
