Lead hardware/software/system design quality engineer supporting the development and launch of the Verily Retinal Camera. Provide medical device product development expertise for Verily's next generation AI/ML driven products. Gained 510(k) approval (K242508) for the next generation Verily retinal camera; enabling AI retinal grading. Management of Quality Engineering resources to support medical device product development.

• Create design and use-case Risk Management Files for Endoscope and Visualization subsystems in accordance with ISO14971 to ensure patient and public safety; driving key hardware and software requirements back into the design cycle

• Provide Design Control guidance and quality insights to the project team in making important project design decisions while collaborating with both Johnson & Johnson (Ethicon) and Google (Verily) partners; ensuring compliance to applicable regulatory requirements and design standards

• Subject Matter Expert for Endoscope and Visualization in defending the Design History File (DHF) in audits from notified bodies; contributing to successful audit outcome and minimizing interruptions to business operations

• Collaborate to building the Quality System for a small medical device start-up; assessing gaps, creating procedures and getting buy-in from company-wide stakeholders as the company continues to grow rapidly and drive towards product launch

• Support the design verification strategy and testing activities for Endoscope and Visualization subsystems; partnering with the cross-functional team to achieve crucial project milestones in a timely manner

• Lead a team of engineers and manage project workflow and timelines while providing crucial product and process-specific training to develop team expertise; efficiently achieving rigorous project milestones with limited resources while shortening cycle times

• Make critical product and project decisions as sole Quality System stakeholder for ophthalmologic product suite; ensuring top product safety functionality and competitive advantage in market place

• Steer the cross-functional team in Design Control through the R&D process; ensuring product compliance from development to manufacturing, allowing smooth product launch

• Spearhead the Risk Management activities for both pre-launch and in-market medical devices by assessing product risks and patient safety to ensure appropriate mitigation are implemented; enabling new products launch with acceptable patient risk level while meeting regulatory requirements and allowing in-market products to continue operations