Product Design, Analytical Instrumentation, Mechatronics, Electrical, and Mechanical Engineering Expert

Expertise

Technical

• Complex, multidisciplinary systems, and subsystems.
• Analytical Instrumentation.
• Liquid Chromatography (LC) and all related technologies including Purification and Supercritical. Fluid Chromatography; LC interface to Mass Spectrometry.
• Mechatronic Products and Systems.
• Mechanical Engineering.
• High-pressure systems.
• IVD Medical Devices.
• Precision machines, semiconductor capital equipment.
• Systems Design and Engineering.
• Product Architecture Synthesis.
• Electromechanical, fluid, thermal, optomechanical, mechanical component, and subsystem design and analysis.
• Control plant modeling.
• Control systems and signal processing - deep understanding and extensive interfacing experience.
• Electrical Systems, electronics, optoelectronics, and embedded software - extensive interfacing experience.

Product Development and Engineering Leadership

• Engineering Management - mechanical, electrical, embedded software, optical, chemical, controls.
• Product Design and Development Process and Practice.
• Engineering Design Process and Practice.
• Engineering Organization Structure and Practice.
• Systems Engineering Process and Practice.
• Project and Project Risk Management Process and Practice.
• Product Risk Management Process and Practice.
• Compliance Engineering applied to (D&), Deactivation and Decommissioning process.
• Intellectual Property-related matters.
• Literate in ISO 9001, ISO 13485, FDA 820.3, ISO 14971, ISO 15288, IEC 62304, EU Directives/CE Mark (IVDD, LVD, EMCD, MD, PED, and others) and harmonized standards, other related regulations, and standards.

Coming up to speed on IVDR and UKCA.

Experience

V.E., LLC, 2021 - Present

Owner and Chief Engineering Officer

Providing clients with the following services:

• Providing product design and product development.
• Product technology and platforms.
• Competitive product analysis.
• Product development processes.
• Modeling and simulation with specialties in mechatronics.
• Independent design reviewer.
• Project and program management practices.
• Engineering and engineering processes.
• Systems engineering.
• Merger and acquisition due diligence.
• Mentoring, training, and training design.

W.C. Corporation, Milford, MA, 1991 - Present

Senior Director, Instrument Development Group/LC Engineering, 2011 - Present

Director, Instrument Product Group; Director, Capillary Systems Group, 2002 - 2011

Research and Development Project Manager II, 1998 - 2002

Research and Development Project Manager I, 1993 - 1998

Principal Mechanical Engineer, 1991 - 1993

Accomplishments

• Led a group of over 110 Engineers, Technicians, and Designers specializing in mechanical, electrical, embedded, and application software, chemical, compliance, verification, and optical disciplines.
• Responsible for design, development, and sustaining engineering for all waters liquid chromatography instruments and systems. Included an engineering group at another U.S. location. 
• Allocated merit and promotion budgets. Submitted and manage department budgets.  Mentored and motivated managers and engineers.  Hired talent and resolved personnel issues.  Several hires were subsequently promoted to director/senior director and high-level technical positions
• Built a solid leadership base in previous roles, including mechanical and system design of ultra, high-pressure pumps; project management of all pumps and purification systems and capillary systems; director of all pumps, and nano and microscale products and systems; director of all mechanical resources and instrument project managers.
• Built a solid track record, contributing to the design, development, architecture, project management, and/or senior management of all of the company's major LC product lines in some capacity. These include Alliance, Modular LC (Liquid Chromatography), LC Purification, ACQUITY UPLC, nano ACQUITY, H Class and H Class bio, I Class, ACQUITY UPC2, ACQUITY APC, ACQUITY M Class, ACQUITY Arc and Arc bio, and SFC/SFE and the Plus and Premier series product lines. 
• These instruments and systems have total cumulative sales in excess of $8 billion, not including attached service, consumable, and application software revenue.
• Delivered projects consistently on or close to target schedule, with minimal concessions. In many cases architected in platform technologies that enabled quicker development of derivative products.
• Participated actively in creating and deploying 3 product development processes; IDP, CIDP, WIDP, which were initially ISO 9001, then later ISO 13485 and FDA 820.3 compliant.
• Authored SOP's on design reviews, engineering reports, design process, etc.
• Literate in IVD, LV, EMC, and Pressure Directives and Harmonized Standards.
• Participated actively in creating and deploying 2 product risk management processes, which were ISO 14971 compliant.
• Developed deep understanding of LC (Liquid Chromatography) instrument design and performance, high-pressure fluid system design including static and dynamic sealing, chromatographic science, project management, project, and product risk management, engineering management, product cost structure, the design review process, product development process, patent initiation and prosecution process, fluid handling and high-pressure microfluidics, system modeling.
• Developed working knowledge of software engineering process, algorithm development, electronic architecture, systems engineering.
• Supported Northeastern University COE as an employer of Engineering Co-op students and full-time engineers, sponsor and mentor for Capstone projects, juror for Capstone competitions, and speaker at student section ASME meeting.

Previous Employment

• Instrumentation Laboratory, Principal Mechanical Engineer, 1989 - 1991
• ADE Corporation, Senior Mechanical Engineer, 1987 - 1989
• CMX Corporation, Senior Mechanical Engineer, 1986 - 1987
• Gerber, Project Engineer/Senior Mechanical Engineer, 1984 - 1986
• GCA Corporation, Senior Mechanical Engineer, 1983 - 1984
• AVCO Systems Division, Mechanical Engineer, 1980 - 1983
• GE Aircraft Engine Group, Mechanical Engineer, Engineering Development,1978 - 1980

Responsibilities

• Completed various projects in aerospace systems, semiconductor capital equipment, industrial garment equipment, optical instruments, and medical devices (instruments).
• Built a rich foundation of engineering knowledge which was only achievable by working in different industries and environments.
• Delivered new and enhanced products, and product improvements.
• Developed excellent written and verbal communication skills.
• Developed deep technical proficiency in electromechanical design, optomechanical design, precision mechanical design, and thermal design.
• Developed working knowledge of servo control systems, signal processing, and electro-optical design.
• Integrated analysis and testing into the design process at all phases, using tools like MathCAD, MATLAB, FEA, etc.

Honors & Publications

Credentials

Course Work

• Leadership development training courses
• Systems Engineering training
• CCL - Leading for Organizational Impact
• Program and Project Management
• Project Risk Management
• Product Risk Management

Academic and Professional Affiliations

• The American Society of Mechanical Engineers-ASME
• International Council on Systems Engineering-INCOSE
• Project Management Institute-PMI
• Institute of Electrical and Electronics Engineers-IEEE
• Member of the Waters Patent Committee

Patents

• Inventor of over 20 U.S. and World patents

Education

• M.S. Electrical Engineering, Control Systems-Signal Processing, Northeastern University, Boston, MA
• M.S. Mechanical Engineering, Mechanics, Northeastern University, Boston MA
• B.S. Mechanical Engineering, Thermo-fluids, Northeastern University, Boston MA.