Experience

MicroBio Consulting

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

• Principal Consultant

  • Jul 2022 - Present

  Principal Consultant- Providing technical and managerial expertise to the medical device industry on a variety of topics including: - Medical device microbiology laboratory management and operation. - Microbiological testing of medical devices in compliance with standard requirements. - Biological safety evaluations for medical devices and related evaluations of materials and changes. - Chemical characterization requirements for medical devices. - Environmental monitoring requirements for medical device production. Show less



Medtronic

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Sr. Director Quality Systems- Global Laboratory Services

  • Feb 2021 - Jun 2022

  Sr. Director Quality Systems- Global Laboratory Services- Providing leadership in the transition of laboratories from various business units into a new Medtronic entity referred to as Global Laboratory Services which includes microbiology, chemical characterization and product stability laboratories.Worked with laboratory leaders to create and implement a transition plan for individual laboratories to be combined into a single quality system entity with an ISO 17025 accredited quality system.Managed cost savings team efforts for Global Laboratory Services for Fiscal Year 22 which exceeded the cost savings goal of 8.7 million dollars by more than two million dollars in the first year of Global Laboratory Services operation.Led a team of subject matter experts to develop new Medtronic global procedures and guidance documents for environmental control, environmental monitoring, endotoxin testing and bioburden testing. This included drafting the initial documents and working with the team to refine them and develop initial training content to support implementation in timing determined by the Medtronic quality system transformation team. Show less

• Center Led Laboratory Director

  • Jan 2019 - Feb 2021

  Center Led Laboratory Director- Providing managerial and technical direction to microbiology, chemistry and stability laboratory operations and biological evaluations performed in North Haven, CT., and Boulder, CO. Examples of these responsibilities include:Reviewing applicable standards related to microbiology, chemistry and stability laboratory operations, and ensuring compliance of MITG procedures and laboratory work instructions.Budgeting department operations and managing these activities within budget.Improving existing tests and services by providing technical review and knowledge of best practices.Management support to microbiology, chemistry, stability and biocompatibility managers and supervisors.Improving biological evaluation documentation consistency by use of templates.Managing implementation of ISO 17025 accredited chemical characterization tests. Show less

• Principle Microbiologist

  • Nov 2014 - Jan 2019

  Principal Microbiologist- Functioning as an interface with diverse cross-functional team members to define and oversee environmental, sterilization and biocompatibility control policies to assure that Medtronic medical devices consistently comply with toxicological, microbiological and particulate contamination control requirements, standards, guidelines and industry practices, both domestic and international. Examples of these responsibilities include:Administering the Environmental Monitoring Program and addressing out of tolerance results.Functioning as the controlled environment administrator to assure compliance with requirements.Providing technical expertise in microbiology laboratory management to improve quality and provide cost effective internal testing options.Coordinating biocompatibility testing and updating biocompatibility assessments as appropriate when products or standards change.Supporting Supplier Quality in assessing supplier changes for potential impact on microbiology and/or biocompatibility of the component or final device.Providing technical expertise and support to Regulatory Affairs related to content of regulatory submissions.Participating in development and maintenance of top level procedures which define requirements for microbiology, sterilization and controlled environments as a member of the Sterility Counsel. Show less



Microbiological Compliance Laboratories LLC, SRL

• Costa Rica

• Chief Science Officer

  • Jan 2012 - Nov 2014

  Drafted a quality system for laboratory start up in Costa Rica which is ISO 17025 compliant. The documents which have been implemented include: A Quality Manual. Method validation procedures and reports. Equipment qualification procedures and reports. Calibration procedures and records. Software validation procedures and reports. Training procedures and records. Test development and validation will be among my ongoing responsibilities. Drafted a quality system for laboratory start up in Costa Rica which is ISO 17025 compliant. The documents which have been implemented include: A Quality Manual. Method validation procedures and reports. Equipment qualification procedures and reports. Calibration procedures and records. Software validation procedures and reports. Training procedures and records. Test development and validation will be among my ongoing responsibilities.



Boston Scientific

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Microbiology Senior Fellow

  • 2001 - Jan 2012

  Microbiology Corporate Steward for all Boston Scientific sites. Provided audit support, leadership on content of Corporate SOPs, provided advice on Microbiology issues such as test failures, developed and maintained microbiology training materials, managed corporate Microbiology related CAPAs, provided input into standard changes and worked with the AMMI Microbiological Methods working group. Microbiology Corporate Steward for all Boston Scientific sites. Provided audit support, leadership on content of Corporate SOPs, provided advice on Microbiology issues such as test failures, developed and maintained microbiology training materials, managed corporate Microbiology related CAPAs, provided input into standard changes and worked with the AMMI Microbiological Methods working group.



W. L. Gore and Associates

• Corporate Microbiologist

  • Jun 1984 - Jun 1998

  I was the Corporate Microbiologist and in this role developed a full service internal Microbiology Laboratory performing LAL Testing, Product Bioburden Testing, Water Testing, Sterility Testing, and Cytotoxicity Testing, as will as a variety of analytical tests using FTIR, GC, GC/MS and HPLC. I was the Corporate Microbiologist and in this role developed a full service internal Microbiology Laboratory performing LAL Testing, Product Bioburden Testing, Water Testing, Sterility Testing, and Cytotoxicity Testing, as will as a variety of analytical tests using FTIR, GC, GC/MS and HPLC.