Carlsbad, California, United States
• Led a 120-person global PMO, R&D, and Applied Research organization across four sites in three countries, including three post-acquisition integrations and annual $20M budget ownership. • Directed 39 major projects across 12 clinical and intraoperative product families, including imaging, robotics, navigation, IONM, and AI/ML systems, resulting in 17 FDA 510(k) submissions, 15 clearances, and 28 commercial releases in four years. • Conceived, developed and launched a connected, web-based digital health surgeon portal and clinical database from the ground up; adopted by 170 surgeons across 44 sites, supporting 90K exams for 52K patients within the first 18 months. • Co-led the development of a formal Data function for the organization. Established the project development processes and mentored the new project manager. • Established a formal PMO and refined Agile software development processes to improve on-time, on-budget delivery across the organization. • Led annual, cross-functional strategic planning and portfolio prioritization efforts.
• Led a team of 11 project management professionals delivering 10 major programs across six product lines, including Excimer and Femtosecond lasers and disposables for LASIK and corneal transplants; Femtosecond laser, phacoemulsification systems, and accessories for cataract surgery; and ocular surface disease treatment and diagnostic platforms. • Directed $50M annual budget, workforce planning, and resource allocation for the Surgical Vision Equipment business. • Drove integration of “Connected OR” technologies across product platforms, including patient data interoperability, advanced imaging, and machine-learning–based treatment planning and visualization. • Chaired weekly and monthly governance forums and phase-gate reviews to ensure schedule, quality, and risk alignment. • Reorganized the Program Management Office (PMO) into a technically focused, execution-driven organization to support accelerated product release timelines. • Established a Reliability Laboratory to validate performance and durability of new product development (NPD) programs. • Created an Engineering Services function to streamline drafting and documentation, enabling engineers to focus on design; implemented PDM processes and vault structures aligned across four global sites. • Implemented an enterprise-level R&D procurement function, reducing administrative load on technical engineering staff. • Founded a Contracts Administration function supporting multiple sites across two continents. • Provided technical leadership for corporate business development initiatives, including cost-reduction programs, manufacturing line transfers, and new facility and laboratory start-ups.
• Led cross-functional program management for a sonogram-based AI device guiding peripheral nerve block (PNB) procedures.
• Defined strategic direction for the Diagnostics product line, aligning technology development with business and clinical objectives. • Provided executive leadership for cross-functional, matrixed new product development across the Diagnostics portfolio. • Built and led a high-performing global team of ~30 engineers across multiple disciplines to develop best-in-class clinical and intraoperative diagnostic and imaging devices for cataract, refractive (LASIK), and retinal surgery. • Led the technical integration of multiple, separately acquired intraoperative diagnostic platforms into a unified product platform. • Led technical Product Support efforts for released products, including foreign registrations and resolution of reliability issues • Served as Functional Manager for the Optics and Diagnostics groups; led talent development for engineers supporting diagnostic systems, lasers, OCT imaging (segmentation and machine learning), and surgical microscope programs.
• Led a second startup through a successful exit by opening and scaling a highly profitable new market segment. • Developed and launched products that have been used to treat over 2 million patients worldwide. • Held full accountability to the Board of Directors and Venture Capital investors for product development, manufacturing, and quality operations. • Built and led high-performance cross-functional teams (20+ staff) including Engineering, Manufacturing, Purchasing, Quality, and Regulatory. • Directed the development and commercial launch of five generations of enterprise-connected intraoperative laser aberrometry systems for cataract surgery, incorporating automated AI-based surgeon- and lens-specific algorithms that delivered best-in-class clinical outcomes. Owned and maintained complete Design History Files (DHFs) for each. • Led the development of a web-based digital health platform supporting surgical planning, measurement and image databases, analytics, reporting, and EHR integration, while ensuring HIPAA compliance and robust security controls. • Provided on-site surgeon training and intraoperative support for clinical trials involving next-generation prototype devices. • Neutralized competitive threats by rapidly demonstrating superior technical performance in response to false competitor claims; delivered a rapid prototype within two weeks and launched commercially over two years ahead of the competitor, which subsequently exited the market. • Drove product and reliability improvement by overhauling the Quality and Reliability program, implementing structured failure codes, trend analysis, and root-cause corrective actions, resulting in substantial reductions in product returns and customer complaints. • As COO, held ultimate responsibility for the corporate QMS, including procedures, document control, training, audits, and regulatory compliance, achieving consistent Notified Body certifications with zero audit findings.