Alex Kubacki Email & Phone Number

San Jose, Ca, Us

San Jose, Ca, Us

• Performs research and assists with early-stage development of neurovascular medical devices• Design medical device components as well as fixtures for inspection/testing of medical device components

• Designs prototype components to assist with early-stage development of vascular medical devices• Develops fixtures to assist with inspection and testing of medical devices and components

Union City, Ca, Us

● Used SolidWorks to create solid models and revision-controlled drawings of existing neurosurgical instruments in order to increase specification accuracy and clarity, improving overall product quality and inspection efficiency.● Designed new instruments/features using SolidWorks, and communicated them to marketing/sales, key opinion leaders, and manufacturers, with the use of solid models, assemblies, detailed drawings, and photorealistic renders.● Created and maintained design history files and design control documentation for product development projects for class I/II devices to stay within ISO 13485 standards.● Increased supplier quality and consistency by leading the Material Review Board and discussing non-conformances in detail with suppliers.● Worked with a variety of materials for new products, including plastics such as Radel and PEEK, and metals such as nitinol, titanium, stainless steel, and nickel-chromium alloy.● Attended a Design Controls course hosted by Oriel Stat A Matrix as part of continuing education.

San Luis Obispo, Ca, Us

As part of a team working directly with Edwards Lifesciences representatives:● Created, modeled, and 3D printed a movable fixture for positioning artificial heart valves under a microscope to speed up the process of product inspection. ● Designed and manufactured cast silicone grips for holding bovine pericardium heart valve leaflets in place for testing without causing damage to them.

Marlborough, Ma, Us

● Carried out inspections and tests on the heart valves and delivery devices of the LOTUS Edge transcatheter heart valve.● Reorganized and added to FMEA Excel spreadsheets.● Worked on equipment verifications/validations and CAPA.● Designed and coordinated new engineering tests and experiments involving LOTUS Edge device disassembly and reassembly.

● Watched swimmers to ensure complete safety for everyone in the pool. ● Monitored and adjusted pool chemicals to keep the water free of pathogens. ● Maintained public relations and provided information to members. ● Opened and closed the pool. ● Carried out maintenance tasks such as cleaning bathrooms and replacing trash can liners.

San Jose, Ca, Us

Scanned for any unsafe activity in the pool. ● Measured and adjusted chemical levels to ensure that the pool is free of bacteria and viruses. ● Collected towels from around the pool and delivered them to the front desk for laundering. ● Assisted in caring for a heat stroke emergency on the tennis courts.