Kenneth Stalker Email & Phone Number

San Marcos, Ca, Us

San Marcos, Ca, Us

Designed cardiovascular catheter (16Fr) for deployment of Nitinol suture for the anchoring of implanted EVAR/TEVAR AAA grafts.- Rapid development and iteration of device for implantation in Pre-Clinical animal models to establish early feasibility.- Developed deployment mechanism and external handle for accurate physician control. Device developed through the use of rapid prototyping, allowing device to be taken to clinical stage (First in Humans) quickly.- Implant design- iterative implant design utilizing laser cut nitnol and various nitinol processing techniques to develop robust implantable suture. - Developed testing protocols for early feasibility testing prior to First In Human.- Developed fatigue, biocompatability and Pre-Clinical protocols including animals and cadaveric models. - Utilized multiple cutting edge manufacturing techniques for catheter design including; Non-Round profile extrusions with difficult polymers, Interrupted Spiral Cut laser cutting of hypotubes for dynamic flexibility profiles, Pushed photoetching to the edge of capabilities to create distal deployment component for suture delivery, MJF Rapid Prototyping, Laser welding, Processed silicone based elastomer and helped develop dipping process for making sub 0.001" flexible membranes for attachment to stent like braid structures.Clinical and Pre-Clinical Experience:- Hands on experience internationally working with physicians in clinical cath lab environments during implants into humans, animals and cadavers.-Understanding of catheter lab equipment and procedures to help physicians understand and use the device successfully under fluoro. -Personally implanted sutures into animal models and cadaveric models, and operated C-arm equipment - Documented usability information from physicians to aid with device development and iterative design. -Helped develop IFU and Investigators brochures-Designed product label from ground up using Adobe Illustrator.

Catheter Design and Manufacturing- Line validation (IQ/OQ/PQ)- Process development / R&D for Intermediate and Micro catheter sizes ranging from 0.017" to 0.072"- Fixture and Tooling development- Equipment software validations - Line improvements and manufacturing ramp up in preparation for commercialization.- Equipment setup, documentation and characterization.- Complete overhaul of labeling system and brought standardization across 3 products families.Quality - NCMR - CAR

-Iterative Product Design -Research and Development

Aliso Viejo, Ca, Us

Developed new heating method for chemical processing of devices including pickling, etching, and passivation. - Evaluated Processes and determined main contributing factors to scrap. - Performed feasibility studies to determine effectiveness of the heating method.- Designed Fixturing and tooling - Improved process without compromising biocompatibility of device. - Decreased setup time and operator downtime by up to 70%.- Reduced process temperature fluctuation which decreased variability in produced partsPerformed Returned Goods Investigations- Documented receipt condition of returned goods and performed functionality tests to confirm or unconfirm complaints.- Provided images and detailed findings for root cause analysis to determine possible causes of failure.- Analyzed SEM images and metallurgical information to determine the cause of material failures.

Temecula, Ca, Us

Provided Engineering support to R&D and manufacturing teams, managed facility, provided IT support and coordinated with various departments to help bring 2 devices to market.Particiapted in Brightwater from founding to sale in June 2019 (Merit Medical, $50m).Process Design, Development, and Improvement- Developed and implemented multiple manufacturing processes, including laser marking from initial receipt of equipment to implementation in production. - Designed and documented fixtures and tooling.Research and Development- Performed long term testing on various materials used in devices for comparative testing such as the impact of long term exposure to chemicals or biological substances. - Conducted viscosity studies of various dairy products to develop a biohazard free human bile analog for flow studies. - Modeled prototypes in SolidWorks for rapid prototyping, plastic injection molding, and some intricate laser-cut components. - Performed and documented tests used for 510(k) filings to the FDA for 2 devices. - Designed Labels for commercial device, and implemented labeling software and processes.Facilities Management- Refurbished and prepared 17,000 sq.ft facility for move from 5,000 sq.ft space.- Coordinated with contractors for building improvements; personally completed other improvement projects.

Aliso Viejo, Ca, Us

Project Lead - Quality Assurance Improvement - Lead project for design, validation, and implementation of custom labeling and packaging QA software. - Performed root cause analysis and created a detailed report on possible solutions.- Wrote two black box software validation protocols that met FDA requirements for software used in manufacturing processes including in-depth risk analysis for implementation. - Researched and purchased all hardware for implementation on multiple assembly lines. -Assisted in transferring the system to offshore facilities (Costa Rica)Moved manufacturing line to a new facility and performed installation and operational qualification (IQ/OQ) on dozens of pieces of equipment.Wrote macros in VBA for thousands of document changes, including manufacturing process change, new device part numbering, and barcode incorporation into documentation for use by software.