Experience

Prodct

• United States
• Business Consulting and Services
• 1 - 100 Employee

• Founder, Managing Director

  • Aug 2018 - Present

  Greater Boston We are NOT your typical advisory firm. We are a boutique, mission-based collection of medical device experts with rolled sleeves, kind hearts, and provocative spirits. We help early stage medical device, diagnostic, and therapeutic companies by creating bespoke strategies and providing thoughtful advisory services. We'll create custom development, quality, and manufacturing strategies that fit you while still aligning with 21 CFR part 820, ISO 13485:2016, and ISO 14971:2019. We backup… Show more We are NOT your typical advisory firm. We are a boutique, mission-based collection of medical device experts with rolled sleeves, kind hearts, and provocative spirits. We help early stage medical device, diagnostic, and therapeutic companies by creating bespoke strategies and providing thoughtful advisory services. We'll create custom development, quality, and manufacturing strategies that fit you while still aligning with 21 CFR part 820, ISO 13485:2016, and ISO 14971:2019. We backup our own advice by deploying experienced resources to help you execute. We know how hard it is to bring impactful medical devices and therapies to market, because we've repeatedly done it successfully. We've been in your shoes and have likely wandered the same trails you're struggling with right now. We've made mistakes, learned from them, and persevered to launch many products and watch them grow. Show less



myBiometry

• United States
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Chief Product Officer (CPO), SVP R&D/Quality

  • Feb 2020 - Present

  Boston, Massachusetts, United States myBiometry is focused on one of the biggest healthcare problems in the world, asthma. Our mission is to help asthma patients prevent symptoms and attacks. Our solution combines digital health, patented sensor and device technology, machine learning, and clinical oversight to turn biomarker data into actionable insights.

• Chair, Technology Advisory Board

  • Feb 2018 - Feb 2020

  Boston, Massachusetts, United States



The National Institutes of Health

• United States
• Biotechnology Research
• 700 & Above Employee

• RADx Tech Content Expert

  • Oct 2020 - Present

  The NIH RADx (Rapid Acceleration of Diagnostics) initiative is a program designed to accelerate the development and deployment of diagnostic technologies, especially during public health emergencies like the COVID-19 pandemic. RADx programs have contributed to the delivery of billions of accurate COVID-19 tests to Americans. Through VentureWell, the NIH RADx initiative assigns “content experts” with specialized expertise in various aspects of diagnostics, biotechnology, and regulatory… Show more The NIH RADx (Rapid Acceleration of Diagnostics) initiative is a program designed to accelerate the development and deployment of diagnostic technologies, especially during public health emergencies like the COVID-19 pandemic. RADx programs have contributed to the delivery of billions of accurate COVID-19 tests to Americans. Through VentureWell, the NIH RADx initiative assigns “content experts” with specialized expertise in various aspects of diagnostics, biotechnology, and regulatory affairs to help RADx-supported companies. I am primarily assigned to help the smaller companies with technical guidance, scale-up strategy, creating product development infrastructure, and establishing robust quality management system (QMS) processes. Author for "Quality and Risk Management" chapter in an upcoming NIH book, “Accelerating Diagnostics In A Time Of Crisis” (published by Cambridge University Press). The book describes the NIH RADx response to COVID-19 and provides a roadmap for future pandemics. Show less



Beken Bio

• Biotechnology Research
• 1 - 100 Employee

• Board Member

  • Jun 2020 - Present

  La Jolla Shores, California, United States



MasksOn.org

• United States
• Medical Equipment Manufacturing

• Board Member

  • Mar 2020 - Present

  Greater Boston MasksOn.org is a physician-led non-profit organization founded to design, manufacture, and donate high-quality emergency personal protective equipment (PPE) to healthcare workers and others on the frontlines of the coronavirus pandemic. The MasksOn.org Reusable Face Shield Kit is a durable and sanitizable emergency PPE made by adapting full-face recreational snorkel masks to connect to bacterial/viral filters already used in hospitals. The organization purchases the snorkel masks… Show more MasksOn.org is a physician-led non-profit organization founded to design, manufacture, and donate high-quality emergency personal protective equipment (PPE) to healthcare workers and others on the frontlines of the coronavirus pandemic. The MasksOn.org Reusable Face Shield Kit is a durable and sanitizable emergency PPE made by adapting full-face recreational snorkel masks to connect to bacterial/viral filters already used in hospitals. The organization purchases the snorkel masks, manufactures filter adaptors and donates the assembled Reusable kits to clinicians and healthcare facilities that lack FDA-cleared PPE. As an all-volunteer effort, funds raised go directly to producing and donating additional kits to frontline healthcare professionals in intensive care units and emergency rooms across the nation where they are needed. Visit MasksOn.org to learn more, request one of our kits, or to make a donation. Show less



Quanterix

• United States
• Biotechnology Research
• 200 - 300 Employee

• Sr. Director, Engineering

  • Aug 2014 - Apr 2018

  Lexington, MA • Drove holistic development of integrated hardware, optics, software, and image analysis algorithm of an early-stage commercial company currently developing transformational, ultra-sensitive immunoassay-driven biomarker detection platforms (HD-1 and SR-X) • Grew engineering organization from 7 to 17, introduced and staffed 2 new functions: System Integration Engineering, Software Test and Validation • Balanced development internally with heavy external input from key collaborators… Show more • Drove holistic development of integrated hardware, optics, software, and image analysis algorithm of an early-stage commercial company currently developing transformational, ultra-sensitive immunoassay-driven biomarker detection platforms (HD-1 and SR-X) • Grew engineering organization from 7 to 17, introduced and staffed 2 new functions: System Integration Engineering, Software Test and Validation • Balanced development internally with heavy external input from key collaborators, partners, engineering development and contract manufacturing organizations in the US and Europe - strategically expanded 4 external partners working on a single product to 11 partners developing or manufacturing 3 products • Introduced field data collection and deep data visualization capabilities to identify product improvements targets - developed a strong continuous improvement roadmap which rapidly improved run reliability and data quality significantly enough to stabilize the product and increase customer satisfaction demonstrated by dramatic increase in consumable pull-through for existing and new customers • Transparency and organization are key for modern teams - Introduced best-in-class team collaboration, communication, and information organization software tools making it easier to find the information needed to keep work moving forward and proactively address challenges to meet key deliverables • Collaborated closely with Research teams to provide technical guidance for next-generation platforms, instruments, or other products and with Sales & Marketing teams to ensure products under development meet commercial expectations and ultimately delight customers • Managed departmental AOPs as high as $6.9M • Built new Program Management Office (PMO) introducing an agile, flexible product development and integrated program management infrastructure (6 months, Nov 17 - Apr 18) Show less



Novartis

• Switzerland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Director, Engineering and Systems

  • Nov 2010 - Aug 2014

  Cambridge, MA • Orchestrated internal and outsourced external activities related to engineering design, software development, and system integration in the research, development, design, and manufacturing of novel diagnostic tests in the Companion Diagnostics (CDx) Unit of Novartis Oncology Global Development • Responsible for instrumentation, engineering, and software solutions across a diverse range of diagnostic testing technologies or methodologies (sequencing, immunohistochemistry, fluorescence in… Show more • Orchestrated internal and outsourced external activities related to engineering design, software development, and system integration in the research, development, design, and manufacturing of novel diagnostic tests in the Companion Diagnostics (CDx) Unit of Novartis Oncology Global Development • Responsible for instrumentation, engineering, and software solutions across a diverse range of diagnostic testing technologies or methodologies (sequencing, immunohistochemistry, fluorescence in situ hybridization, etc…) to create IVD tests used during pharma registrational clinical trials and ultimately as FDA cleared, Companion Diagnostic systems requiring Class III controls and PMA submission • Advised and evaluated engineering aspects of business development and due diligence efforts for several strategic partnership, merger, and acquisition targets. Support associated Quality and Mfg audits • Drove adoption of systems thinking and demonstrate successful utilization of key analysis or modeling tools, especially those commonly grouped under the umbrella of Design for Six Sigma (DFSS) or Design for Manufacturing (DFM) and across all internal and external diagnostic projects • As part of a rapidly growing small organization, lead creation of engineering or system-specific design controls (e.g. specification/requirement setting and justification, process instruction creation, receiving inspection), monitored design capability metrics to assure consistent design robustness, facilitated failure investigations as appropriate, and executed system design verification/validation activities Show less



Ventana Medical Systems

• United States
• Biotechnology Research
• 700 & Above Employee

• Director, Development

  • Jan 2010 - Nov 2010

  Tucson, AZ • Transitioned from engineering to broader commercial team as a cross-functional global "Program Leader" of large, diverse project teams - responsible for ensuring alignment of product capabilities with the overall platform/reagent strategy and leading entire project to meet development/launch milestones, budget and business needs • Established strategic direction for the program team and interfaced very frequently with upper-most executive review boards • Drove data informed… Show more • Transitioned from engineering to broader commercial team as a cross-functional global "Program Leader" of large, diverse project teams - responsible for ensuring alignment of product capabilities with the overall platform/reagent strategy and leading entire project to meet development/launch milestones, budget and business needs • Established strategic direction for the program team and interfaced very frequently with upper-most executive review boards • Drove data informed, model-rich, and intelligent trade-off decisions that meet business needs while simultaneously addressing developmental technical, regulatory, and operational issues. Quickly focused team debate/discussion around key issues that determine product quality, requirements, and functionality while satisfying customer requirements • Fostered and promoted a positive environment by instilling a sense of urgency and strong can-do attitude in team, especially while proactively challenging functions on delivery challenges or building development of scenarios and alternatives that can guide strategic decision making • Responsible for building and maintaining annual budgets over $11M, aggressive timelines, risk mitigation plans, and resources. Oversaw technical teams, key suppliers, executing successful regulatory strategies, driving operations readiness, inventory ramp-up, new product launch, and early commercialization training/support

• Sr. Manager, Development

  • Sep 2008 - Jan 2010

  Tucson, AZ • As "Core Team Leader", commanded a large, matrix organized team of scientists, chemists, engineers, finance, regulatory, legal, service, operations, and marketing personnel while managing budgets in excess of $5M to mature the development of the SYMPHONY primary staining platform, a Class I exempt IVD medical device intended to seize, build, and maintain global medical and market leadership • Made timely decisions and strategic, executive recommendations, often with incomplete data, to… Show more • As "Core Team Leader", commanded a large, matrix organized team of scientists, chemists, engineers, finance, regulatory, legal, service, operations, and marketing personnel while managing budgets in excess of $5M to mature the development of the SYMPHONY primary staining platform, a Class I exempt IVD medical device intended to seize, build, and maintain global medical and market leadership • Made timely decisions and strategic, executive recommendations, often with incomplete data, to identify and address new risks while managing highly optimized resources and integrating company-wide input to execute instrument improvements to high standards • Responsible for accelerating medical adoption and improving commercial success of the SYMPHONY instrument, software, and reagents by establishing a meaningful and data-driven stream of constant product improvements and service enhancements • Worked closely with representatives across the company that interacts with SYMPHONY to understand and address emerging field adoption challenges during early commercialization

• Engineering Manager, Primary Staining Business Unit

  • Apr 2006 - Sep 2008

  Tucson, AZ • Engineering representation on SYMPHONY Core Team for all key stakeholder interactions, both internally and externally with development partners and customers • Managed activities and provided guidance as necessary to members of the Engineering and Engineering Services (technicians, drafters) functional groups in the Primary Staining Business Unit while working closely with other groups (Chemistry, Systems Integration) on development of diagnostic tests • Accountable for ensuring… Show more • Engineering representation on SYMPHONY Core Team for all key stakeholder interactions, both internally and externally with development partners and customers • Managed activities and provided guidance as necessary to members of the Engineering and Engineering Services (technicians, drafters) functional groups in the Primary Staining Business Unit while working closely with other groups (Chemistry, Systems Integration) on development of diagnostic tests • Accountable for ensuring hardware design meets product functional requirements and applicable standards (FDA, CSA, CE) • Responsible for DFSS root cause analysis of failures during system verification/validation before launch and ensuring smooth transition into manufacturing. Strong advocate of Design for Excellence (DFx) principles with significant experience regarding Design for Reliability, Manufacturability, and Serviceability • Demonstrated exceptionally strong interdisciplinary engineering background (mechanical engineering, systems engineering and architecture, fluidics, optics, plastics, and disposable design)

• Sr. Mechanical Engineer

  • Dec 2004 - Apr 2006

  Tucson, AZ • Technical Team Leader during development & commercialization of Discovery XT, Benchmark XT, and Symphony w/ responsibilities for orchestrating system architecture + contributing individual designs • Drove adoption of ANSI standards and GD&T methodologies for all design/drafting across the organization • Acted as liaison between development and manufacturing to ensure a smooth transition • Earned a reputation for being a cross-boundary collaborator and holistic leader (not… Show more • Technical Team Leader during development & commercialization of Discovery XT, Benchmark XT, and Symphony w/ responsibilities for orchestrating system architecture + contributing individual designs • Drove adoption of ANSI standards and GD&T methodologies for all design/drafting across the organization • Acted as liaison between development and manufacturing to ensure a smooth transition • Earned a reputation for being a cross-boundary collaborator and holistic leader (not development-centric)

• Mechanical Engineer

  • Jan 1999 - Dec 2004

  Tucson, AZ • Designed and implemented multiple aspects of several new or recently released IVD platforms and disposable products including NexES Special Stains, BenchMark, and Discovery instrument systems • Contributed to the modernization and utilization of CAE analysis tools to improve digital confident in designs prior to prototyping • Contributed heavily toward solving critical FloLok and FloLok II fluid dispenser solution field deployment issues with existing reagent dispensing disposables



ADE Phase Shift

• Opto-Mechanical Engineer

  • Oct 1998 - Jan 1999

  • Opto-mechanical design of high precision, non-contact surface metrology instruments • Worked full time while completing Master's degree



Tuff Tread (http://www.noramcofitness.com/)

• Mechanical Engineer

  • Jun 1997 - Oct 1998

  Tucson, Arizona • Design, fabricate, and manufacture novel treadmills for early-stage commercial exercise start-up • Analyze production costs and develop cost reducing design decisions • Worked full time while studying for Master's degree



Polypipe

• United Kingdom
• Plastics Manufacturing
• 400 - 500 Employee

• Contract Mechanical Engineer

  • Jun 1997 - Oct 1998

  • Design new industrial piping and valve products, check valves, and a patentable ball valve • Research and improve upon existing CSR Polypipe valve designs using AutoCad 3D solid modeling • Worked part time while studying for my Master's degree



Richard F. Caris Mirror Lab

• Opto-Mechanical Engineering Research Assistant

  • May 1993 - Aug 1996

  Tucson, Arizona • Designed and fabricated the mechanical aspects for a broad variety of optical testing systems including a large scale, piezoelectric driven vertical interferometer to image 8.4 meter diameter telescope mirrors • Significant hands-on experience with manual machining equipment (mills, lathes, etc…) as I built everything I designed • Worked part-time during undergraduate studies Note: Previously "Steward Observatory Mirror Lab" https://mirrorlab.arizona.edu/