EXPERIENCE
Industry Consultant 2009-Present
- Startup company responsible for fostering and providing guidance for Medical Device and Biopharmaceutical Companies globally around three main competencies: Design Controls / Quality System Requirements Consulting, Product Development and Distribution.
- Quality Consulting for Medical Device and Biopharmaceutical Companies providing expertise in all aspects of Design Controls /QSR, MDD, MDR, and ISO Compliance, Design Transfer, Gap Analysis, Risk Management (including compliance to IEC 60601 and ISO14971-2019 DRAFT), Combination Products, Remediation and Training.
- Provide expertise to ensure compliance to US and EU statutory, regulatory, and technical standards and design guidance using QSIT methodology as well as developing and implementing strategies for building compliant and sustainable quality systems.
ConMed (Bard) Endoscopic Technologies Chelmsford, MA 2004-09
VICE PRESIDENT- NEW PRODUCT DEVELOPMENT
- Created and drove the strategic R&D direction of core product segments through organic growth and external partnerships to support both short and long term business goals. Responsible for budgeting and planning.
- Managed an interdisciplinary group which successfully designed and commercialized Class I, II, and III medical devices and consumables. This included Argon Plasma/Bipolar generators surgical suturing and clipping devices, automated biopsy guns, biopsy forceps, polypectomy snares, dilatation balloons, homeostasis probes, ligation devices, retrieval devices, directional catheters, and enteral feeding devices.
- Developed, established, and implemented formal design controls/development processes, procedures and best practices to assure compliance to US and EU statutory, regulatory, and technical standards.
- Developed and executed Global Integration plans for major product and technology acquisitions including standardizing Requirements to meet all FDA, QSR, ISO and CE requirements, Design Transfer into and from global facilities (transfers included updating and confirmation of all aspects of the design including verification and validation), creation of DHF/DMR, pilot manufacturing with onsite confirmations and production scale up.
- Managed Global Life Cycle including Design, Pilot Manufacturing, Scale-up and production of over 35 major product lines US, Europe, Mexico, Puerto Rico, and Asia.
- Oversaw entire DHF development, creation of the DMR, Design Transfer into Manufacturing through pilot production and Post Market Surveillance. This included Development Planning and Monitoring, Design Requirements, Risk Management, Engineering Specifications, Product Performance, Verification/Validation, and Design Control Requirements.
- Responsible for technical and project management, from conceptual design development, clinical evaluations and studies, IDE studies, regulatory submissions and international registrations, market preference testing and commercialization phases through post market.
- Chaired R&D corporate council responsible for leading innovation in best practices and technology assessment, across the global markets.
- Expanded global operations reach to include R&D, product development and manufacturing in China and Asia Pacific.
- Developed strong MD, KOL relationships in support VOC oriented product development
- Divisional Patent Officer
Bard Endoscopic Technologies Division, C.R. Bard Billerica, MA 1986-2004
Director/Vice President- NEW PRODUCT DEVELOPMENT 1999-2004
- Commercialized the first endoscopic treatment and procedure for gastroesophageal reflux disease (GERD) using a revolutionary differentiated suturing system.
- Member for over six years on the Bard R&D Corporate Council responsible for allocation of over $120mm annually in Long Term R&D Initiative programs, technology mapping, idea generation, pipeline management utilizing velocity metrics, inventor ship programs, scientific awards and state of the art strategic portfolio management tools.
Engineering Manager - NEW PRODUCT DEVELOPMENT 1995-1999
- Drove the strategic R&D direction of two major business units through organic growth and external partnerships while refining the VOC process in order to be first in the market place.
Development Engineer to Engineering Manager- NPD 1986-1995
- Delivered key product commercialization’s exceeding $80mm in revenue annually through individual contribution and project team leadership.
EDUCATION:
BS Bioelectrical Engineering, University of Massachusetts, Amherst, MA
PROFESSIONAL DEVELOPMENT:
Summit on Future Medical Device Innovations to the Marketplace
Post Graduate Courses in Bariatric Surgery
Post Graduate Courses in Interventional Laparoscopy
Post Graduate Courses in Interventional Medicine (ACGE)
Post Graduate Courses in Techniques in Endoscopic Therapy in Gastrointestinal Diseases (Georgetown University)
Post Graduate Courses in Advanced Therapeutic Endoscopy
1995 Charles Russell Bard Award Winner (World Wide Award Program Recognizing Employee Excellence)
PATENTS:
Five Issued/Three Pending