Greater Boston
Results oriented medical device R&D Executive providing rapid new product development. Excellent record in nurturing innovative R&D teams committed to working collaboratively and cross functionally in the development of electro-mechanical and disposable medical products. Highly driven professional with the ability to launch unique proprietary products with a clinically based value proposition. Specialties: VOC, Innovation, & IP Management Pipeline Planning,Talent Management, & Recruiting Project Management, Sustaining Engineering Quality Systems, Design Controls, & Regulatory Compliance Contract Manufacturing, Engineering Services
Rejoined Respiratory Motion (RMI) as operations leader managing Engineering, Manufacturing, RA/QA, and Clinical Research. Recruited a new team of 6 leaders representing product development (Software, Mechanical, and Systems), Clinical Research, Manufacturing, and RA/QA. Launched the company’s next generation product, ExSpiron 2Xi in the US and Europe within 8 months. Successfully supported the sale of RMI to Senzime for $44M (July 2022). • Managed and focused team on a prioritized new product pipeline • Developed and drove all project, resource, and budget management • Upgraded the quality system, and regulatory capabilities enabling successful implementation on key projects (International Registrations and the transition from MDD to MDR) • Managed global patent portfolio (system, device, and disposable) (8 issued, 5 pending) • Successfully created and implemented a Performance Management System • Managed integration of RMI/Senzime activities with relocation of R&D, Mfg., and QA/RA to Sweden
Led a multi-functional co-located team, in US and Canada consisting of product development, manufacturing, and RA/QA. Established a strong new product pipeline. Implemented a successful company-wide stage gate product development process. Developed and drove all project and resource management. Transitioned company from research to product development/commercial focus. • Developed company’s first new product pipeline and technology roadmap • Completed the transfer of InMotion robot from in-house manufacturing to an external contract manufacturer • Implemented new design control procedures and an integrated stage gate process • Reconfigured software/system development team to support company’s pivot to InMotion Connect Data Driven Cloud Based Stroke Therapy Solutions
Built and led a 25 person cross-functional team consisting of internal and external resources encompassing product development, manufacturing, RA/QA, and procurement. Hands-on engineering leader successfully brought start-up company’s first product from concept through commercialization in 10 months. • Created strong new product pipeline and technology roadmap • Developed and drove all project and resource management • Transitioned start-up company from research to development focus • Implemented design control procedures and a stage gate review process • Achieved 510(k) equivalence for the ExSpiron 1Xi respiratory monitoring system • Developed IP with multiple patent filings • Implemented quality system, documentation control, procurement, and QA/inspection functions • Relocated company to a larger facility to accommodate larger staff and in-house manufacturing
Led a global R&D group of 30 in the development of electro-mechanical thrombosis prevention systems in the Vascular Therapies GBU. Collaborated with cross functional leaders and built a strong technical team to fuel new product introductions. Responsible for all aspects of R&D: concept, technical feasibility, product development, clinical evaluations, quality system compliance, sustaining engineering and talent management. • Launched 15 new products including both durable electro-mechanical systems and single-use devices over 10 years resulting in exceptional market share position and global sales growth ($140M to $400M) • Developed a strong patent portfolio in the thrombosis prevention space obtaining key competitive advantage extending to 2030 • Built a global team of technical professionals located in Mansfield, MA and Shanghai (hired first Covidien R&D engineers in China) • Completed the acquisition technical due diligence and successful integration of Novamedix (Sales $40M)