Executive Summary:

Strong knowledge of all aspects of medical device design, manufacturing process validation and regulatory strategy.

Managed IQ/OQ/PQ process for manufacturing of insulin pump and associated consumables.

Participated in all ISO and FDA audits as it pertained to products within my responsibility.

Senior company manager leading the development of medical devices. Single use sterile disposables.

Managed multiple projects through “Phase Gate” development process.

Led sterilization (EO) validation process.

Established tools for cost estimating in order to track and maintain business objectives.

Led multi-discipline technical teams for advanced electronic devices. (embedded s/w, electrical and mechanical engineering)

Strong knowledge of injection molding process, tooling and secondary operations.

P/L responsibilities including establishing manufacturing and business performance metrics.

Established infrastructure for manufacturing within an ISO 13485 and FDA regulated environment.

Authored project development plan for electronic drug delivery systems.

Primary business, technical contact and interface with product development partners.

Developed plan to transfer insulin pump manufacturing from pilot facility to production manufacturing.

Led team researching Electronic Medical Records requirements in oncology infusion centers.

Led business development efforts to secure two major product development contracts.

Worked extensively with major stakeholders in the Artificial Pancreas Project.

Created clinical contacts for the development of pulsatile cardiopulmonary by-pass pump.

Senior Consultant, InfusSafe LLC., September 2014-Present

Broad based medical device manager with extensive experience in manufacturing/operations management. All aspects of drug delivery safety, with business development experience in injectable drug delivery markets.

Oncology

Pain Management

Insulin Delivery

Market Research/Program Manager, DEKA Research and Development, September 2013-October 2014

Developed plan for collecting appropriate market information in order to evaluate intravenous infusion market opportunities in developing economies.

Established in theater contacts.

Interviewed clinicians, regulators and healthcare administrators.

Developed plan to establish intravenous infusion business in developing economies.

Acting Director of Sustaining Engineering, Vapotherm Inc. February 2013- September 2013

Responsible for leading sustaining engineering team of 5 people through component and process qualification of existing installed base devices.

Support operations in moving production manufacturing from Maryland to New Hampshire.

Maintained engineering module of company new enterprise management database.

Managed a cross functional team of software, electrical and mechanical engineering, including key suppliers.

Program Management, DEKA Research and Development Corporation, May 2008 – November 2012

Reporting to the president and founder, manage all aspects of Intravenous Infusion Therapy and Diabetes product development, including development of partner relationships, multi-discipline technical team of 15-20 engineers, regulatory affairs and device process validation and introduction to manufacturing.

Managed all aspects of key suppliers and service vendors for product development.

Additionally, received FDA 510(k) clearance to market insulin pump and all sterile consumables 2009.

General Manager, PGM Plastics, Inc. 2006 – April 2008

Reporting to the president and owner of PGM Plastics, manage day to day operations of a 24/7 custom injection molding and contract manufacturing business. Implementing company initiatives for creating an environment suitable for medical device disposable manufacturing such as ISO 13485 compliance.

President, Databased, Inc., 2000 - 2006

Consulting Positions and Clients:

Acting General Manger, PGM Plastics, Inc. 2005

Consulting directly to the president of PGM, evaluated the company for entrance into medical device and pharmaceutical market. Performed ISO to FDA QSR’s gap analysis and implemented procedural changes for FDA QSR compliance. Provided high level evaluation and report to the president regarding PGM’s ability to enter and support business in the medical device and/or pharmaceutical industries.

The Mack Group, 2005 - 2006

Developed clinical returns and clinical data recovery system for pharmaceutical client with iontophoretic drug delivery/device technology.

Massachusetts General Hospital/ Harvard Medical School AIDS Research Group, 2003 - 2004

Created the development team to investigate technologies for portable CD4 cell counting device. This research lead to the creation of start-up Daktari Diagnostics Inc. Responsibilities included monitoring team objectives and report development progress to Medical Director of AIDS Research Group.

Project Manager, Bose Corporation, 2000 - 2006

Provided business development, engineering and manufacturing services to assist in the investigation of Bose Corporation’s core technologies in medical devices.

Acting Director of Business Development, Design Mentor, Inc., 2000 - 2002

Responsible for the development of customer base, strategic alliances and provided company direction with senior management. Established working relationship with University of Massachusetts Medical School, Cardiac Surgery Department for clinical support of medical products under development.

Other Positions/Employers:

Director, Manufacturing, FluidSense Corporation, 1998 - 2000

Led the development team from product concept through verification and validation testing, and successful clinical trials of intravenous infusion therapy system. Established supply base by pre-qualification of critical suppliers. Selected and managed contract manufacturing partners.

Director of Operations, Elan Pharmaceutical Research Corporation, 1996 - 1998

Provided technical input for “Design For Manufacturing” (DFM). Developed domestic supplier base for MEDIPADâ a small volume subcutaneous drug delivery device, which was transferred to a domestic manufacturing partner from the development team in Israel. Managed international logistics and created infrastructure for drug (narcotic)/delivery device manufacturing.

Project Manager, DEKA Research and Development Corporation, 1990 - 1996

Managed activities for transfer of proprietary pumping technologies to licensing partner’s in house manufacturing facilities. Successful product transfers included:

Alaris Medical (currently Carefusion)l, ReadyMEDÔ disposable infusion pump.

Project Engineer, Bose Corporation, 1985 - 1990

Member of advanced development team responsible for design and introduction to manufacturing of high performance audio systems for new customers. Primary responsibility of mechanical packaging and transfer to manufacturing. Customers included Mercedes-Benz, Audi, Acura, Nissan and General Motors Corporation. Extensive international travel to work on site with customer development teams.

Professional Training:

Statistics, Harvard Extension School

Project Management, Worcester Polytechnic Institute

Education:

Southeastern Massachusetts University 1978-1980

Mechanical Engineering

Patents Issued or Pending:

Sterile frangible product to maintain sterile barrier between powder and liquid. (Blood Handling)

Ultrasonic weld joint to hermetically seal flexible PVC to rigid acrylic. (Peritoneal Dialysis)

Elastomeric pumping device. (Antibiotics)

Elastomeric pumping device with sequential valves. (Multi-drug Dosing)

Small volume parenteral drug cartridge with air-entrapment plunger.

Intravenous in-line aspirator and infusion monitoring device.

“Near to patient” (NTP) diagnostics algorithm and device.

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