SUMMARY:

• 25+ years engineering and product development experience of increasing responsibility resulting in over 25 successful product launches, many patents for new devices and technology, and several group turnarounds.
• 15+ years of engineering management experience managing cross - functional teams with 20-70 staff members of systems, software, GUI, mechanical, electrical, firmware, engineers and designers; as well as project managers.
• 12+ years leading medical device development resulting in 9 instrument or system introductions at major medical technology providers such as Confidential, Confidential & Confidential, Confidential, Confidential & Confidential, and Confidential .
• Key member of a founding leadership team that grew a company to over $85M in just over 3 years.
• Proven track record of successfully leading engineering groups to deliver quality products on time and on budget.
• Hands-on, customer - focused, technical leader with acute business acumen and the unique ability to inspire development teams to perform at high levels while delivering leading edge technology to market.
• Expert in the development of instruments and disposables used in the medical device and health care industry.
• Broad background of engineering and management experience including hardware, mechanical, electrical, GUI, software, materials, systems engineering, international safety and, and product industrial design.

TECHNICAL SKILLS:

Software Tool: Pro/Engineer and Pro/Mechanica & Pro/Intralink, Unigraphics, Ansys, Flotherm, COSMOS, Nastran, CADKey, Agile, Hypermesh, Mentor Graphics, ORCAD, Solidworks, DOORS, SAP, MS-Project, MS-Office

PROFESSIONAL EXPERIENCE:

Confidential

Chief System Architect & Electromechanical Technical Lead

Responsibilities:

• Sr Principal Electromechanical Engineer in the development of a major subsystem used in an advanced new mechatronic surgical system.
• Technical lead engineer and system architect for an hand-held active respiratory inhaler designed to deliver COPD drugs to global Confidential ts using ultrasonic deconglomeration and synthetic jetting, mechatronic indexing, compliance tracking, embedded computer and data communication technologies. The rechargeable hybrid system supported the delivery of a year of pulmonary therapy drugs via the use of rechargeable reusable and matching replaceable drug cartridges.
• Lead development engineer for a robotic surgical system imaging subsystem from concept to system integration. Work with a cross-functional engineering team designing the electromechanical and optical components using Solidworks for the endoscope attached to the robotic system. The 3D imaging system is housed in a Titanium 6X11X20mm hermetically sealed enclosure designed to be sterilized in an autoclave or using hydrogen peroxide plasma.

Confidential (Batesville, IN)

Project Manager

Responsibilities:

• Led a $14M development project and cross-functional engineering group of 35 engineers in development of a new leading edge global bariatric bed product. The product which embodies a user controlled adjustable electromechanical frame which supports Confidential ts up to 1000 pounds; as well as self-propelled transport, a motorized expandable sleep deck, integrated electronic scale, and a computer controlled mattress that provides Confidential t with skin care and pulmonary therapy. The product is a class 2 medical device designed for compliance to the latest FDA and IEC 60101-2 3rd Edition regulations and standards. Two new product innovations have been submitted for patent.

Confidential (Safety Harbor, Fl)

President & Principal Engineer

Responsibilities:

• Led the design, engineering, and project management activities for electromechanical and electronic product development such as electromechanical medical devices as well as automated machines and instruments. Led an engineering team from customer requirement definition to system integration of a hand-held test instrument for a leading portable optical telecommunications test instrument provider. Completed a new product design of a negative pressure wound therapy dressing system for Confidential & Confidential and leading its transfer to contract manufacturing with on time and on budget development. Led the development of several devices and new research technologies for use in Confidential t procedures or clinical research by doctors, clinicians, and researchers for Mayo Clinic Division of Engineering. Provided direction to several companies on effective and compliant medical device engineering and product development as well as provided several investment groups insights into the technology trends in the medical device and technology market. Prepared proposals for several new customer design project opportunities.

Confidential (Pinellas Park, Fl)

Global Platform R&D Director (Tampa Bay Operations Closed)

Responsibilities:

• Led cross-functional teams in the development of new automated peritoneal dialysis systems and the sustaining of the installed base. The new system developed was the first in over 10 years, requiring an engineering team of over 45 members. We successfully completed the design in preparation for verification and validation for the 510(k) submission within 18 months.
• The new system was designed to satisfy the global market and simplify operational logistics while greatly enhancing the Confidential t’s therapy experience. This was through an improved user interface utilizing color graphics and voice guidance, dramatic noise quality improvements, and significant reliability and serviceability enhancements. This position had global responsibility for product and regulatory acceptance with a budget of over $8M per year.

Confidential (Meriden, CT)

Executive Program Manager

Responsibilities:

• Responsible for leading business unit department heads and their staff in transitioning all products to meet the EU RoHS and WEEE directives. My activities included generating plans, processes, project schedules, executive reports, and managing the project activities for the entire business unit. The ultimate objective in being WEEE compliant in 3 months and RoHS compliant on over 300 products in 12 months. Became expert in design for RoHS compliance, while mitigating the impacts on the global homologation requirements for electronic products caused by the RoHS/WEEE directives.

Confidential (Clearwater, Fl)

Staff Vice President

Responsibilities:

• Responsible for investigating corporate wide product quality, cost, and delivery issues and ultimately developing strategies for getting them back on track. Interfaced with every department in the organization to uncover causes of customer complaints or product issues and delivered detailed plans for their mitigation. Produced a plan to implement a data collection system and database to track component and product quality from incoming inspection through end-of-life with the customer. Conducted detailed research on the impact of the EU RoHS/WEEE directives on the business and produced a detailed plan to minimize those impacts. Often participated in new product concept or development planning and assisted with the resolution of engineering schedule problems and product EMC compliance issues.

Confidential (St. Petersburg, Fl) irector of Engineering

Responsibilities:

• Responsible for managing a 70 person-engineering group which generated $14M in defense related contract engineering revenue per year. My department provided the engineering staff to support over 12 simultaneous research and development programs. These programs were primarily involved in power management, surveillance, radiometry, telemetry, sensor, and monitoring systems. I recruited and hired managers in the electrical and software areas to help create a more accountable and productive team. Revitalized the organization by dealing appropriately with non-performers, hiring several new high performing engineers, and putting into place new processes and tools. We successfully implemented and achieved ISO9000 in less than 6 months. Engineering maintained a 98% on time delivery of projects and other deliverables under my management.

Confidential (Clearwater, Fl)

Director of Engineering

Responsibilities:

• Participated in building Confidential ’s engineering group from the ground up. Recruited and hired personnel, set up processes and procedures, and acquired tools and systems to build a world class development team geared for rapid product development of high density portable and integrated optical telecommunications instrumentation. Under my management the organization consisting of over 60 engineers, designers, and technicians has averaged a major new product introduction every six months. We consistently delivered products, which met all requirements and cost objectives. The business grew from $10M to $100M sales in three years. CEO recognition received for engineering’s zero non-conformances in year 2000 ISO 9000 audit. Patent ed for device idea used in a rack mounted instrument, another pending. Acted in the role of Vice President of Research & Development for the last year of employment while we downsized the engineering group to 6 engineers.

Confidential (Tampa, Fl)

Engineering & Project Manager

Responsibilities:

• Responsible for managing the development and engineering of instruments used in the monitoring of vital signs of medical Confidential ts. Managed the Confidential t monitoring electromechanical development group including several engineers, designers, and technicians. Worked closely with marketing, customers, and industrial designers to establish product development specifications, budgets, schedules and design strategy for a team to develop both integrated and modular electronic Confidential t monitoring instruments.
• Lead the introduction of state-of-the-art tools (i.e. Pro/Engineer, Mechanica, & Mentor Graphics) and processes to design analyze, and prototype plastics and die-cast enclosures, and electronic circuits used to produce our products. Using this technology and facilitating high performance development teams we were able to produce high quality products in less than 6 months and on budget. Two patents were ed for devices and mechanisms invented.

Confidential (Rochester, NY)

Senior Project Engineer

Responsibilities:

• Responsible for establishing methods and standards at Kodak Custom Equipment, Business Imaging and Health Sciences Divisions for the effective use of Unigraphics II and Pro/Engineer for the three-dimensional (3D) design, documentation and production of their products. Responsible for managing the development of a auto-loader for a computer radiography system.
• Entailed conceptual design, cost estimation, DFMA, and CAD system database procedures for the product. Also played a primary role in the engineering of the system; including, drive-train and mechanism design, sensor selection and for computer control and interface. Used Unigraphics II CAE/CAD/CAM for machine design and layout. Involved in several areas of development and engineering on projects designing instrumentation and business machines. Used CAE tools such as Nastran, Hypermesh, and Mechanica to perform analysis of parts and assemblies. Designed high-speed drive and sensor systems for optics positioning on a $1M+ instrument designed to measure film quality in real-time at all EK film production facilities. Responsible for all structural foam enclosure components and thermal management system for the EK Advanstar digital microfilm scanner printer. Three patents ed for mechanisms or systems developed and used in products.

Confidential (Tampa, Fl)

CAE/CAD/CAM Consultant

Responsibilities:

• Responsible for account development and sales of Confidential Douglas’s broad family of computer integrated manufacturing systems and software in the Southeastern United States. Received extensive product and sales in many CIM tools including Unigraphics II CAE/CAD/CAM, Nastran and Ansys Finite Element Analysis, Automated Data Collection Systems, Robotic Graphic Programming and Distributed Numerical Control.

Confidential (Oldsmar, Fl)

Industrial Controls Specialist

Responsibilities:

• Selected for the Westinghouse Industrial Control Business Unit management fast track after being recruited from college. I had the responsibility to coordinate all custom control requests, from responding to RFPs through estimation, quotations, engineering and design, as well as installation. I also had the opportunity to be a field salesman working a territory as an industrial controls specialist. Ultimately I was given the responsibility as product line manager where I defined marketing campaigns, defined product requirements for engineering, pricing and discount structures, and end of life plans for a line of variable voltage solid state motor controls. I introduced two new motor controls that were very successful in the marketplace resulting in several millions of revenue for the division.