Director of Engineering
Professional Profile Seasoned engineering executive with an acute business sense. Proven track record of rapidly bringing products to market. Measured, hands-on leader with proven management and collaboration abilities. Successfully motivates individuals from diverse disciplines. Ability to marshal resources to effect change and achieve goals. Demonstrated excellence in strategic planning. History of successfully bringing technically complex programs to fruition.
Specific Strengths
• Team recruiting and organizational effectiveness • Leading cross-functional teams toward a common mission
• Development methodologies and best practices • Third-party alliances and strategic partnerships
• Design engineering background • International business experience
Selected Accomplishments Intelligent Controls
Reorganized and created an effective Product Development Department that successfully inspired new ideas through innovation, but without losing focus on customers’ needs and company’s long-term business objectives
Instrumentation Laboratory
Selected to rescue a $10M program, diagnosing procedural deficiencies and successfully implementing specific design control procedures in line with FDA cGMP requirements
PE Biosystems/Applera
Successfully directed business collaborations and partnerships while managing the development of a high-throughput drug screening system with program partner Johnson & Johnson
Areas of Expertise Instrumentation • Functional/Program Management • Regulatory • Capital Equipment
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Experience
Consultant
2007 to present Created the business plan and complete development/marketing strategy for a cardiac catheter product. Sought funding and support for this early-stage company.
Director, Clinical Product Development
2005 to 2006 Bruker BioSpin, Corp. - Billerica, MA
Headed an international program to develop and position a spectrometer product line based on nuclear magnetic resonance (NMR) technology for applications in the clinical diagnostics market.
For strategic reasons, Bruker BioSpin cancelled clinical program in 2006 • Sought and created new business opportunities in the clinical diagnostics space with a focus on leveraging existing core technological competencies toward a completely new market.
• Led engineering and scientific teams in Europe and the US to define and develop FDA approved, state-of-the-art NMR instrumentation and targeted in-vitro diagnostic applications for metabolic screening, pharmacogenomics, and early detection of Type II Diabetes.
• Drove strategic partnerships for biomarker discovery with biotechnology, pharmaceutical, and academic organizations.
Principal
2003 to 2005 Technology Consulting
Provide engineering services and program direction for new product development and technology innovation to emerging companies
• Retained by a medical device start-up to determine engineering resource needs and create a development plan for an ophthalmic diagnostic instrument
• Recruited to manage the development of a closed-loop thermal control system
Vice President, Product Development
2002-2003 INTELLIGENT CONTROLS, INC. (Franklin Electric) - Saco, Maine
Headed Product Development for this developer/manufacturer of control instrumentation. Directed management staff and offered program oversight. Key member of senior management team reporting to the president and CEO: provided input to corporate strategy and objectives.
Intelligent Controls was acquired by Franklin Electric and relocated to the Midwest in 2003. • Restructured Engineering Department, resulting in projected increased revenue of $5 million. Enhanced productivity, motivated and improved morale of staff
• Created and implemented resource capacity plan, based on available resources, the company’s project portfolio, market demand, and launch time frame. Result: Clearer decisions concerning the viability of existing and proposed projects
• Convinced reluctant client of superior new technology, resulting in a new 5-year revenue stream totaling $2.5 million
• Constantly made make versus buy decisions and evaluated the competency of potential business partners with an eye toward enhancing company’s strategic position in the marketplace
• Opened European market for one product line by spearheading acquisition of CE and ATEX marks, directing all regulatory and safety efforts
Engineering Director, Instrument Development
2000-2002 INSTRUMENTATION LABORATORY - Lexington, MA
Led Engineering Department for this $280M diagnostic instrumentation company within a complex FDA-regulated environment. Provided technical assessment of new technology trends to senior management. Directed a staff of engineers and technical specialists, as well as third-parties, in the development of in-vitro diagnostic instruments.
• Developed aggressive engineering department plan in line with the overall business plan, including project cost forecasts, comprehensive program schedule
• Regrouped then headed new product review board, resulting in improved ability to proactively address product problems and the timely resolution of all product issues
• Salvaged $10M design and development program that was one full year behind schedule. Result: Managed the redesign of a high-throughput blood coagulation analyzer with 25% more throughput than existing products. Guided the dedicated development team and outside resources; met FDA 510(k), CE, and UL regulatory requirements, collaborated with Manufacturing and Marketing on beta-site deployment and product launch
• Led a $4M program to develop a state-of-the-art blood gas analyzer
• Established and implemented new design control process, including new department-wide database and change control process (based on FDA GMP guidelines)
• Recruited, managed, and mentored senior and principle level engineers to meet the needs of a dynamic R&D environment
Engineering Manager, Research & Development
1994-2000 PE BIOSYSTEMS (a division of Applera Corp) - Framingham, MA
Recruited to join this company specializing in products for the Life Sciences. Created, built and led engineering team. Steered technical development, scheduled/budgeted programs, and directed business collaborations and partnerships. System architect and hands-on contributor to electrical design
• Headed the overall development of an automated, high-throughput, drug screening system for client company Johnson & Johnson
• Led the in-house design of a fluoroscopic detector used for capillary electrophoreses and drove the development effort through strong technical leadership and key hands-on contributions to the design
• Directed outsourcing of key components, saving several million dollars in materials and reducing the total design cycle time by 24 months
• Managed an effective strategic collaboration with other firms that increased PE’s long-term competitive advantage
Senior Electrical Engineer, Research & Development
Lead electrical design engineer for the Chromatography Development Group. Managed one senior software engineer and two senior electronics technicians. Led cross-functional development projects. Designed electrical circuits and developed real-time embedded software.
• Managed high-performance pump project, resulting in enhanced product performance with cost savings of $3,000/unit
• Managed electrical valve cost reduction project, resulting in savings of $800/unit
• Senior electronics designer, developing all electronics for the Chromatography Group: Wrote real-time embedded software, designed control systems and circuitry
Electrical Engineer, Research & Development/ Manufacturing
1990-1994 VARIAN ASSOCIATES (Vacuum Instruments Division, - Lexington, MA)
Design engineer for this world leader in ultra-high vacuum instruments. Designed analog, digital, and microcontroller circuits for helium mass spectrometer leak detectors. Supported manufacturing floor and field service.
• Developed electronics for mass spectrometry leak detector line
• Successfully developed universal remote-control hand-held unit for new and existing instruments
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Education and Professional Development
B.S., Electrical and Computer Engineering
(Magna cum Laude)
Northeastern University - Boston, MA
Professional Development MIT Sloan School – Executive Program
• Managing Technical Professionals and Organizations
• Developing and Managing a Successful Technology and Product Strategy
WPI – Continuing and Professional Education
• Managing the New Product Development Process
• Advanced Project Management
Foreign Languages Chinese Mandarin -- conversational |
