Engineering Design and Consulting

Head executive of wholly owned subsidiary of W.L. Gore & Associates, Pipeline Medical Technologies (PMT). PMT is a 20 employee strong medical technology company focused on advancing chordal repair for degenerative mitral regurgitation (DMR) via a transcatheter procedure.- As an independent business, managed our leadership team in all matters: Clin/Qual/Reg/Eng/Ops/Finance/HR/Etc. - Owned resource allocation and financial forecast/spending to manage program to 10-15M budget - Managed diverse board of investors and parent company representatives to retain enthusiasm and vision alignment- Negotiated two new facility leases and COVID remote migration to allow team to grow and remain effective- Delivered successful minimally viable product on time and under budget- Worked to create a "colleagues first" culture by implementing numerous programs/policies: 401(k) program, generous time off policy, standing all hands meeting, shout outs, company provided off-sites and lunches, cloud migration to enable remote work, annual reviews and incentives, etc. resulting in strong morale and nearly zero turnover.- Responsible for influencing team internally and parent company externally to ensure goal alignment while maintaining fast paced startup company environment following acquisition- Recruited and built team of exceptional talent, doubling the company's size- Implemented metrics and dashboards across key functions of the business to provide better visibility, improve communication, and help drive data based decisions. - Responsible for building and maintaining relationships with key customers as technical and business leader representative- Promoted business to new clinical sites to increase engagement and build out clinical trial participation

- Built first clinical versions of the device and managed team of 10 engineers and technicians- Coauthored successful IDE and OUS regulatory submissions with multiple amendments

- Owner of several complex steerable delivery catheters and corresponding implant components- As "Voice of Pipeline" scrubbed in as primary technical support in the cath lab at sites across 3 continents

Additional Responsibilities:• Day to day management and oversight of R&D Department including signature authority, material review board, field assurance meeting, field operations meeting, CAPA review board and engineering meetings. • Develop R&D project plans containing complete scope of work identifying all project requirements, tasks, resource assignments and an accurate estimate for task completion• Champion and drive new product projects through the company product commercialization process• Manage expense and capital spending associated with projects and facilitate purchasing as required• Lead, motivate and inspire project cross-functional team members• Communicate status and updates for projects – keep stake holders informed of project progress and potential roadblocks• Coordinate projects from initiation through delivery; planning and directing completion of all required product development activities or project deliverables• Coordinates team efforts to develop and document design history files per design control requirementsProjects:• Completed and filed multiple provisional patents on next generation products• Continued to support roll-out of Sentinel product to US market by supporting and training new clinical sites• Trained new Field Clinical Specialists to support US market• Drove and completed several continuous improvement projects to increase yield and decrease cost

Additional Responsibilities:• Identify and initiate opportunities for improvement to device performance, quality systems, supply chain, and company objectives• Supervise assigned technicians. Lead and manage complex projects.• Independently determine day to day tasks. Complete projects with exemplary documentation, leaving a legacy in DHF, specs etc.• Maintain contact with and gather feedback from key physicians involved in the company's product development programs.• Proficient with computerized project schedulingProjects:• Project Lead for all company R & D projects• Provide technical field support for roll out of Sentinel IDE and R&D pipeline products• Recruit and interview prospective operators and support staff• Owner of design control system and returned goods investigation• Mentor and aid in development of new engineers and engineering interns

Additional Responsibilities:• Conduct basic design review meetings as needed.• Procure and oversee outside vendors and consultants as required.• CAD Proficiency• Working knowledge of the patent processProjects:• Design control Project Leader for Sentinel cerebral protection product• Provide technical field support for roll out of Sentinel product in cases in Europe and Canada• Assisted in development of training program for physicians and distributor representatives• Primary technical support for IDE Submission • Recruit and interview prospective operators and support staff• Marketing artwork generation and various catheter design improvements

Additional Responsibilities:• Solve moderately complex problems at the component level.• Demonstrate understanding of experimental design.• Actively participate in determining day to day tasks.Projects:• Injection molding design of catheter handle including 11 separate multipiece mold tools, material selection and relationship management with China based manufacturer• Primary technical support for CE Mark and subsequent supplements • Lead and executed design verification for multiple device iterations including prototyping, protocols, testing, reporting and manufacturing implementation• Signature authority for R&D Department on document change requests • Partner with quality in generation and closure of NCMRs, CAPAs, Complaints and RGAs• Assist in development of validation protocols and execution of IQ/OQ/PQs in facility move• Solid modeling of entire product, laser ablation of thin films, and manufacturing fixtures

• Design and develop new products as well as product changes and enhancements which are consistent with a zero defect level as well as low product cost. Solve basic problems at the component level.• Conduct testing utilizing established test protocols. Accurately generate written reports.• Supervise assigned technicians and temporary workers on an informal basis.• Complete projects (including product enhancements) in an aggressive manner consistent with corporate objectives.• Contribute to the intellectual property position of the company via invention and patent applications. Maintain accurate documentation of concepts, designs, drawings, and processes.• Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to the company’s products. • Provide engineering and technical support of products introduced into both the domestic and international markets as well as physician in-service programs.• With supervisory assistance, procure and oversee outside vendors and consultants as required.• Maintain GMP systems, including pre-production QA procedures, pre-clinical testing programs, and post production GMP compliance in coordination with the Doc Control, Clinical, and QA functions. Provide support in the resolution of product complaints and/or safety issues.• Work with the MFG, Clinical, Sales and Marketing, and QA functions to coordinate pilot production of new products.• Support company goals, objectives, policies, procedures, GMP, and FDA regulations.• Maintain a professional, credible image with key physicians, consultants, vendors, and co-workers.Projects:• Authored first draft of Design FMECA and aided team to finalize along with Process FMECA• Performed extensive investigation into weight composition and ingredients of all device colorants • Primary technical contact for multiple critical vendors• Micro resistance welding, metal crimping and swaging, device packaging

-Maintain laboratory equipment and inventory-Instruct graduate and undergraduatestudents in the use of laboratory equipment, device fabrication and procedures-Plan and lead cleanup, tutorials and meetings necessary for the lab

-Assisted Professors with 3 courses over the year which included managing and performing grading-Aided Professors with student interface and course related questions

Manufacturing fixture design, development, and implementation for torque driver functional testing in Solidworks including DOE.Extensive literature review to develop data set of skeletal loading conditions created by radius and ulna diaphyseal fractures.Tensile testing, receiving inspection, cadaver labs, document control.

‐ Worked with ASTM and ISO standards to develop test methods for design validation for the delivery system for a percutaneous heart valve‐ Managed project for balloon blowing and inflation channel loading in latest generation device including management of a team of technicians ‐ Hands on experience with catheter manufacture, balloon blowing, tissue attachment, animal lab, vendor relations, clean room environment, and document control ‐ Prototyped design elements and test fixtures in on site machine shop

‐ Position emphasizes multiculturalism, community service, team building ‐ Responsible for daily leadership requiring crisis response, counseling, mediation, group dynamics, and role modeling by drawing on in depth-training‐ Perform administrative responsibilities consisting of duty / on-call rotation, front desk management and operation, and planning programs for up to 200 students