Jay Joseph Email & Phone Number

Santa Cruz, California, US

Santa Cruz, CA, US

Geneva, Switzerland, CH

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.

Belmont, California, US

• 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

Marlborough, MA, US

• 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

Marlborough, MA, US

• 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

Marlborough, MA, US

• 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

Marlborough, MA, US

• 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

Marlborough, MA, US

• 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

Marlborough, MA, US

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

Marlborough, MA, US

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

Danvers, MA, US

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

B.S., Bio-Engineering

M.S., Manufacturing Systems Engineering