Train physicians and support staff in the effective use of the AccuCinch system, a transcatheter device used to treat heart failure patients. Proctor physicians during pre-clinical and clinical cases. Perform analysis of screening and follow-up imaging studies (CT, echo, fluoro), and communicate results to internal team members as well as clinical sites.

- Analyzed patient screening CTs using multiple software packages and implemented work flow processes with the field, clinical and R&D groups that reduced the average time to respond to a site’s screening CT by 50%. - Developed and led the CT imaging analysis training program resulting in scalability of patient screening, decreased time to enrollment and suitable patient eligibility, leading to good clinical outcomes and meeting corporate objectives for early feasibility study rollout. - Presented to the physician-led patient review committee results of screening CT analyses, including explanations of anatomies that may present a challenge during delivery, to ensure best selection of patients into the clinical trials. - Prepared the delivery systems and valve in the sterile hybrid OR / cath lab during clinical studies of the Caisson transcatheter mitral valve, helping to result in successful procedural outcomes with no delays due to preparation. - Produced and verified the IFU for sterile field preparation of the valve delivery system and trained field personnel to this, both in group and 1:1 settings, resulting in documented competency and depth of skill within the therapy development team. - After each procedure, assisted in the review of case notes and imaging, comparing predicted assessments vs. actual performance, and making recommendations for improvements in screening, pre-procedural planning, and delivery. - Designed and implemented new models which resulted in more realistic pre-procedural assessments and training. - Created content for improvements in post-implantation CT exams, and delivered this training to physicians and staff, to ensure good quality imaging throughout clinical sites, resulting in accurate assessments of implanted device and study endpoints.

- Managed six engineers in the peripheral vascular group by defining goals, working collaboratively through technical and team-related issues, and guiding their professional development. - Designed and implemented a method to assess tip integrity of a crossing catheter during challenging simulations and benchmark its performance against competitive products. - Worked cross-functionally as a core team member to drive predictable execution of project schedules while keeping quality and patient safety at the forefront.

- Project leader for the valve delivery system of the Caisson transcatheter mitral valve (class III device), with primary responsibility for designing, prototyping and testing of this nested catheter system, including means to successfully load, deploy, deliver, reposition, and retrieve the valve; achieved requirements within budget and timeline. - Established a fluoroscopic-based method of use for valve delivery, using radiographic markers in the distal tip of the catheter system to unambiguously guide the user in its deployment, and validated this with KOL advisors. - Developed didactic and hands-on material to train interventionalist and surgeon advisors in the use of the valve delivery system; worked with them to understand their concerns and implemented changes to address these, in order to optimize the design of the delivery system. - Served as the subject matter expert in pre-clinical animal studies for valve delivery, including its preparation in the sterile field; developed a strong working knowledge of cardiac anatomy and the cath lab environment.

- Managed engineers to launch two spinal interbody fusion devices, and worked with the sales team and surgeons to track performance and benchmark competitive products, resulting in guidance for next generation systems. - Delivered training to the sales force as well as implanting surgeons on new products and their procedural use, through hands-on simulated models, cadaver workshops, and didactic presentations. - Designed, prototyped, and assessed custom surgical instruments to address specific user needs. - Provided engineering case support for a clinical study of a spinal nucleus replacement and created case summary reports.- Worked with internal groups to resolve manufacturing issues and ensure compliance to the quality system.

- Managed the activities of an external design firm for the successful development and launch of a femoral intramedullary (IM) nail system, with a novel distal locking means (the DISTALOCK™ drill). - Led the development efforts for a complementary tibial IM nail system, and verification of a new drill design. - Developed materials to train the sales team to ensure their aptitude with the procedure, and provided technical support for the commercial launch of the DISTALOCK™ femoral intramedullary (IM) nail system.

- Led internal project teams, outside design firms, and worked closely with implanting surgeons to successfully design and develop instruments, delivery systems and surgical methods to facilitate the DASCOR® spinal nucleus replacement system (class III device) in being implanted through a variety of surgical approaches, including a mini-open posterolateral approach and an endoscopic approach, which achieved a major company milestone. - Led validation studies and created didactic content for cadaver training labs for surgeons in the use of DASCOR®, resulting in successful procedural execution in clinical trials and European launch. - Served as the engineering subject matter expert for DASCOR® procedures, developed content to train the field team in the use of a new injector system for DASCOR® procedures, and in the use of updated surgical instruments and methods; documented competency through performance-based assessments.- Created content and trained the field team to a series of ‘what-if’ procedural scenarios, resulting in consistency and appropriateness of response to these situations, and worked with the clinical team to gather study data and prepare case summaries for internal review. - Worked cross-functionally with regulatory and quality to ensure that development efforts were performed in accordance with the quality management system, and that documentation for FDA submissions was accurate. - Worked with our patent attorney to develop the company’s intellectual property portfolio, as well as evaluated new technologies from surgeons and companies to assess their value.

- Project leader for the successful launch of five allograft-based spinal interbody fusion systems, with primary responsibility for the design, development and verification of implants, surgical instruments, and methods of use. - Managed the Cervical Spine Product Development Group, consisting of an engineer and a designer. Planned resources, budgets and timelines necessary to successfully support the company’s development goals. - Led cross-functional efforts to identify and implement process improvements to increase profitability of structural allograft (Graftech®) product lines; reject rates reduced by 50% and qualifying donor yields increased by 25%. - Served as the engineering subject matter expert for training symposiums, sales meetings and cadaver labs.- Kept current with market trends through research on competitive products and customer interviews and worked cross-functionally to develop product comparison summaries. - Worked closely with intellectual property attorneys to screen and patent novel implant and instrument ideas, as well as to research content to create freedom-to-practice opinions.

-Performed design, development, and verification activities of the Angio-Seal™, a femoral puncture closure device, and led development of new test fixtures and methods resulting in a more clinically relevant shelf-life protocol. -Coordinated internal cross-functional efforts to ensure successful outcomes for OEM customers on a variety of orthopedic implants manufactured using injection molded biodegradable materials.