Alcon acquired PowerVision March 2019-Fluid filled accommodating intraocular lens

Ophthalmology - Accommodating Intraocular Lens• Expansion of responsibilities to include Operations and Facilities• Lead department of 40 associates including Engineers, managers, machine shop and assemblers. • Lead and executed Process Development strategies for next generation Intraocular Lens.

• Responsible for Manufacturing Engineering • Implemented production metrics and effectively managed clinical builds and design verification activities• Initiated process validation activities to prepare for OUS product launch• Reduction of scrap and doubled final product yield

Managed and responsible for:• Expansion of responsibilities to include Valve and Catheter Operations, Valve Process Development Engineering, and critical supplier management• Managed a team of Process Development Engineers, an Operations Supervisor with 45 Operators & Inspectors, and Maintenance Techs to take a product from Clinical to Commercial• Responsible for leading team to a COGS reduction on the heart valve implant through design changes and lower cost manufacturing processes

Managed and responsible for:• Aortic Valve manufacturing and design changes for the valve implant• Aortic Valve and Delivery System Operations - Operations support, ramp up, and transfers to Canada and Ireland (including a 6mo relocation project in Galway, Ireland)• Process Development Projects - Goal to reduce COGS• Next Generation Projects – Low profile catheter Delivery System (reducing French size) and line extensions• IQC• Equipment Maintenance & CalibrationResponsible for leading engineering team to develop and implement design and process changes to reduce COGS with a 5 year NPV of $105 million and to facilitate an aggressive commercial ramp-up• Machined to Plastic injection molded parts• Machined to metal injection molded parts• Wire forming to sheet metal photoetching• Machined to sheet metal laser cutting• Multilumen extrusions and extrusion assembly• Material changes to the Implant and all necessary Biocompatibility, Durability, and Tissue Fatigue testing necessary for those changes

• Managed and trained 12 direct reports: 4 Quality Engineers, 1 QE intern, and 7 QC Inspectors• Key Operations player for volume ramp up to support Clinical Trials• Developed Design & Process Controls for Aortic Tissue Heart ValvesManaged and responsible for: • Operations Quality (Heart Valve Implant, Delivery System, and Chemical Solutions)• Process Validation & Test Method Validation• Valve & Tissue Inspection Certification Programs• Final Product System Functional Testing• Product Release for CE Trials• Microbiology (Endotoxin & Bioburden)• Terminal Chemical Sterilization & Parametric Release• Environmental Monitoring• Problem Solving for Engineers Bay Area Trainer (Six Sigma Yellow Belt Equivalent)o Operations Quality Metrics & MRB CoordinationCross Functional Core Team Member for New Product Development• Catheter Delivery System• Paravalvular Polyurethane Seal• Heart Valve Implant• Cost of Goods (COGs) Reduction

• Primary Operations Quality Engineer for Transcatheter Aortic Valve Replacement System • Developed QC procedures and test methods for tissue valve inspection, SEM and Keyence laser measurement system• Doubled QC inspection capacity within one quarter and eliminated in-process QC as an Operation’s bottleneck• Developed training presentations to Operations for GMP, GDP and Six Sigma Yellow Belt • Core team member for design investigation team tasked with solving device durability problem and implementing corrective actions in order to restart clinical trials for Heart Valve Implant

• Planned and executed detailed phases of engineering work as part of a variety of Operations projects: Production line site transfers, process improvement projects and wide range of problem solving projects• More recent tasks included the mentoring and development of junior engineers by utilizing root cause analysis tools• Developed excellent working knowledge and application of validation techniques• Actively promoted and participated in a cross-functional teamwork environment by advocating the pursuit of the right solution rather than the easy one

• Developed, characterized and optimized processes using statistical techniques and engineering knowledge • Developed and executed process validations• Designed and executed DOEs (Design of Experiments)

• Analyzed process, product, material and equipment specifications and performance requirements• Designed and built fixtures equipment to enhance process development

R&D Intern working on power supply for Abiocor Artificial Implantable Heart Project.