SUMMARY
Laboratory Automation Design and Manufacturing
Medical Device Design and Manufacturing
Process Equipment Design and Manufacturing
Consumables Design and Manufacturing
Manufacturing Operations Leadership
Business Development and Sales Experience
Quality and Manufacturing Improvements
Cross Functional Team Leadership
Program and Project Management
Regulatory Compliance Expertise
04/2017 to present
Philips Healthcare
Andover, MA 01810
https://www.usa.philips.com/healthcare
Philips Healthcare is a global leader with innovative products and services in the consumer product, medical device and medical equipment field. Our department provides regulatory and reliability testing for new and revised products. My role is to project manage the following: manufacturability analysis and recommendations, design and fabrication of product prototypes, tooling and fixture design for R&D and Manufacturing, and tool design for product testing.
Senior Program Manager
● Assumed responsibilities for product reliability testing tool and fixture design, and fabrication shop management
● Developed improved project tracking and reporting tools
● Initiated cost accounting and forecasting methods where none existed prior
● Management of a full service fabrication lab including: CAD/CAM services, CNC machining, sheet metal fabrication, assembly, metrology services and 3D printing
01/2014 to 11/2016
T2 Biosystems, Inc.
Lexington, MA 01803
www.t2biosystems.com
T2 Biosystems is an ISO 13485 certified, Class 2 medical device manufacturer. The mission is to develop and deliver diagnostic products that provide fast and accurate results. The T2Dx instrument employs robotics for fully automated whole blood sample preparation and a proprietary detector. The reagents, controls and consumable products are produced in high volume.
Director, Hardware Engineering
● Led project teams for new product development (diagnostic instruments) and sustaining engineering for marketed Class 2 IVD products
● Improve product reliability using HALT and HASS and feedback from Complaint Handling procedures
● Employ Design For Manufacturing (DFM) techniques to improve ease of manufacturing and reduce costs
● Increased completeness of documentation enabling the option for Contract Manufacturing
● Transition the T2Dx instrument to manufacturing under Design Controls (FDA 21 CFR 820.30)
● Leadership and membership on cross functional teams including QA, marketing, field service, manufacturing and accounting
Selected Results
● Contributed to hemostasis instrument development (T2Plex) under design controls; pre-clinical release to manufacturing for beta build
● Improved T2Dx instrument reliability (94% to 98%) as a Process of Continuous Improvement program
● Reduced cost of procured parts and sub-systems by optimizing designs, reducing fastener and part counts.
● Team leader on successful document management system upgrade
● Engineering representative to ERP implementation
● Created numerous SOPs and Work Instructions for R&D and Manufacturing processes
● Team member for ISO 13485 certification process
● Successfully completed all regulatory testing requirements: ETL, IEC 61010 and 61326
● Member of EH&S committee
09/2007 - 09/2013
Howard Hughes Medical Institute
Ashburn, VA 20147
http://www.janelia.org
The Janelia Farm Research Campus was in start-up mode and focused on basic research in neuroscience. The mission of the Instrument Design Facility was to provide commercially unavailable, simple to complex tools and systems using electro-mechanical, machine vision, electronic and software solutions for campus based researchers. A key focus was in fast laser illumination, camera based data acquisition systems, and microscope applications development.
Director, Instrument Design and Fabrication
● Initiated the function, hired and trained staff; built out the support infrastructure needed
● A leader of leaders – was responsible for program management, technical architecture, fabrication, staffing, systems design, development, project management and support for a rapidly growing team (17 engineers and technicians)
● Build a comprehensive manufacturing capability: electro-mechanical assembly, CNC machine shop, rapid prototyping, sheet metal, welding, laser cutting. Fabrication was performed in all plastics and metals
● Managed a rapidly growing outsource consulting and manufacturing function
Selected Results:
● Developed automated systems for genetic engineering, vivarium operations and research animal model assays
● Developed numerous automated animal behavioral assays using machine vision data acquisition
● Used Stage-Gate PM for a workload that increased >600% from 2007 to 2011
● Implemented an enterprise program and project management tool – Clarizen
○ Improved on progress and financial accounting reporting
● Improved Return on Expenses from 15% to 75%
● Submitted multiple technology solutions for licensing and commercialization (by self and the ID&F team),
● Spun out two technologies and start-up companies (Vidrio and Hudson-Price Design)
03/2004 to 05/2007
Microfluidics Corp. (now part of IDEX Corp.)
Newton, MA 02464
http://www.microfluidicscorp.com/
Microfluidics was a publicly held corporation and the technical leader in high-shear fluid processing equipment. The markets served were bio-pharmaceutical, chemical, foods and coatings. Product design complied with US (FDA and USDA) and European agencies for IEC and CE. We updated the design and development process to comply with design control guidance for FDA/GMP.
VP, Engineering
● Responsible for program management, new product design and development, project management, sales support, low volume/high mix manufacturing, and customer relationship management.
Results:
● Hands-on business development, domestic and Asia. Increased sales, acted as Voice of Customer
● Achievement of >35% revenue growth in second year
● Reduced Cost of Quality (50%) by re-designing components that failed frequently under high-pressure loads. Used FEA to review design options, made selections and implemented so...
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