Experience

Cala Health

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

• Vice President, Operations & Quality

  • Jan 2022 - Present

• Vice President, Manufacturing & Quality

  • Feb 2021 - Jan 2022



miraDry, Inc.

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

• Vice President, Manufacturing

  • Apr 2012 - Apr 2020

  Lead manufacturing team to ramp production and supply chain in step with increased sales. Develop lean manufacturing culture, engaging team members at all levels to reduce waste and increase efficiency through continuous improvement. Also leading production, manufacturing engineering, service, purchasing, materials and logistics teams. Lead manufacturing team to ramp production and supply chain in step with increased sales. Develop lean manufacturing culture, engaging team members at all levels to reduce waste and increase efficiency through continuous improvement. Also leading production, manufacturing engineering, service, purchasing, materials and logistics teams.



ZOLL Circulation

• Vice President, Operations

  • 2007 - Apr 2012

  Directly responsible for the management and direction of the Operations team to ensure product is built as designed, in volume to support the sales forecast, and of the highest quality. Responsibilities include management of production, shipping/receiving, manufacturing engineering, purchasing, supply chain management, and service. Products include the AutoPulse (Class III, 510(k) cleared medical device that provides mechanical chest compressions in the delivery of CPR) and the CoolGuad and ThermoGuard systems (Class II, 510(k) cleared intravascular therapeutic hypothermia systems, includes disposable catheter). Combined revenue for all products is $40M. Show less

• General Manager

  • 2005 - 2007

  P&L and operating responsibility for 42-person division supporting $14M in sales. Directly responsible for R&D, Manufacturing, Quality Assurance, and Regulatory Affairs functions, reporting directly to the CEO of ZOLL Medical for 2 years until replacement General Manager was hired.



Revivant

• Medical Equipment Manufacturing

• Director of Product Engineering

  • 2003 - 2005

  Responsible for all engineering activities associated with sustaining and improving the AutoPulse. Functionally managed a team of 3 software engineers, 4 mechanical engineers, and 4 electrical engineers. Led cross-functional project team to develop the next generation AutoPulse to improve reliability, lower cost, and simplify assembly. (new product development, design controls, design transfer, commercial launch activities, customer acceptance trials)

• Software Engineering Manager

  • 2002 - 2003

  Responsible for all product and process software development. Managed a team of 5 software engineers, including 2 consultants. Took on additional project management responsibilities to incorporate the use of a gearbox with an integrated encoder into the existing AutoPulse device. (Schlaer-Mellor, MS Visual Source Safe, TASKING C compiler, performance appraisals, software project management, 510(k) clearance for medical device, FDA Design Controls, ISO)



Amira Medical

• Director of Manufacturing/New Products

  • 2001 - 2002

  Responsible for engineering support of the AtLast blood glucose meter manufacturing line. Managed team of 4 engineers. Took on additional project management responsibilities for the next generation meter. Company was purchased by Roche and dismantled. (SMBG business, new product development, design controls, design transfer, commercial launch activities, IQ/OQ/PQ) Responsible for engineering support of the AtLast blood glucose meter manufacturing line. Managed team of 4 engineers. Took on additional project management responsibilities for the next generation meter. Company was purchased by Roche and dismantled. (SMBG business, new product development, design controls, design transfer, commercial launch activities, IQ/OQ/PQ)



Symphonix Devices

• Software Development Manager

  • 1999 - 2001

  Oversaw the development and test of product and process software, reporting to the Vice President of R&D. Responsibilities included supervising software test and development engineers, hiring contract software development and test resources, project planning, and evaluating third-party software. (MS Project, performance appraisals, software project management, active implantable medical device, FDA Design Controls, ISO)

• Senior Product Development Engineer

  • 1997 - 1999

  Responsible for the design and development of embedded firmware for a surgically implanted hearing aid and associated programming software. Was also responsible for developing production test software. (Borland C++, Microsoft Visual C++, Xemics XE8301 CoolRISC assembly, GNU-C, QVCS, Object-Oriented Analysis/Design)



LifeScan

• Medical Equipment Manufacturing
• 700 & Above Employee

• SureStep Team Leader - Instrument Operations

  • 1996 - 1997

  Responsible for the production of SureStep™ brand blood glucose meters. This involved planning production to meet forecast, overseeing continuous improvement of the existing manufacturing line and supporting the introduction of new and/or improved meters based on the SureStep technology. (DFT, project management, performance appraisals, budgets, resource planning, recruiting)Represented Instrument Operations on a fast cycle team to improve an existing glucose meter. Was responsible for managing a team of cross-functional engineers (software, hardware, manufacturing, and test) to modify the existing manufacturing line to accommodate hardware changes to the meter. This included manufacturing prototype boards, modifying test equipment, and ensuring parts availability for the various stages of the project. (project management, time management, team leadership) Show less

• Software Engineering Team Leader - Operations

  • 1995 - 1996

  Managed and lead the team chartered with the development and validation of software to support the assembly, test, calibration, packaging and device history record tracking of ONE TOUCH® and SureStep™ brand blood glucose meters. (C, C++, BASIC, Delphi, Windows NT, DOS, VXI, PLC)

• Senior Software Engineer

  • 1994 - 1995

  Designed and developed the embedded software for the ONE TOUCH® ProfileTM Diabetes Tracking System and made improvements to the ONE TOUCH® II Hospital Blood Glucose Meter. Worked closely with Marketing to define features and the user interface. Worked closely with Electrical Engineers toevaluate meter components and custom ASIC. (C, 8051 assembly, EMUL51-PC emulator)

• Software Quality Engineer

  • 1993 - 1994

  Worked with software engineers to ensure compliance with FDA software development guidelines and recommendations for medical devices. Wrote Software QA Plans, validation protocols, and test reports. Performed audits and reviewed documentation and code. (8051 assembly, C, C++)



Varian

• Senior Software Engineer

  • 1985 - 1993

  Was responsible for the definition, hands-on implementation and management of software projects. Worked directly with customers to define software requirements. Developed real-time control software, using multi-tasking operating systems, for the Varian M2000. Developed embedded process control software for the Varian 3180. (Z80 assembly, GPIB, VAXserver 3100, VAX, C, VMS, Tektronix C, VME, 68030, pSOS) Was responsible for the definition, hands-on implementation and management of software projects. Worked directly with customers to define software requirements. Developed real-time control software, using multi-tasking operating systems, for the Varian M2000. Developed embedded process control software for the Varian 3180. (Z80 assembly, GPIB, VAXserver 3100, VAX, C, VMS, Tektronix C, VME, 68030, pSOS)