Andrew Lamb

Experience

• 

  Worcester Polytechnic Institute

  Jan 2010 - Jan 2014

  Student
• 

  Zimmer Biomet

  Oct 2014 - Sept 2015

  Development Engineer

  Worked in a cross-departmental Remediation team toward the improved documentation of orthopedic implants Revised current documentation to meet FDA standards while consulting the quality, regulatory, clinical, manufacturing, and design departments to create consistency and traceability within product filesReviewed and analyzed design history files to address validation and verification gaps by such means as clinical evidence, risk management, similar device analysis, and manufacturing changes to prints/surgical techniquesUtilized post-market information, complaints, and clinical data to prove positive performance of productsPerformed supplier risk analysis using relevant quality data to address product non-conformances and complaints Show less

• 

  Conformis - acquired by restor3d

  Oct 2015 - Aug 2017

  CAD Engineer II

  Work with a team of engineers to design patient-specific knee implants utilizing CT Scan data.Peer review femoral and tibial implant designs for compliance with design protocol and FDA regulationsTrain team members in SolidWorks 2015 and company specific programs on various design processesOrganize and conduct team quality meetings to ensure ideal and accurate design processes.Evaluate software package updates to optimize efficacy and efficiency in implant design and review Conduct analysis of design processes to maximize quality and efficiency to reach team goals and production demands. Show less

• 

  Philips Ambulatory Virtual Care

  Aug 2017 - now

  Work Experience:• Manage and execute R&D, Manufacturing, Operations, and Quality related projects for Medical Device Company• Work with a team to develop a state-of-the-art cellular-enabled Connected Blood Glucose Monitoring System • Analyze and troubleshoot post-market data following product launch to recommend corrective actions• Create and revise Design Control documentation for current and future products• Lead project for multiple Connected Blood Glucose Meter generations for population health through Design Controls• Supervise remote Software Development Team as Product Owner to develop and support device applications• Initialize and complete product updates through Change Control • Commercialize next generation device following completion of all Design ControlsProject Experience:BioTel Care Blood Glucose Monitoring System (BGM) 4 – Commercialized December 2020• Commercialized Next-Generation Class II Medical Device with new form-factor, updated user- interface, and applications• Defined specific hardware and software requirements used during the design and development of the device• Worked with various stakeholders and development teams to ensure successful planning and development of new product• Completed all required Phase Gates of the Design Control process while ensuring all requirements are met and approved BioTel Care BGM 2 - Commercialized April 2018 and October 2019• Worked with cross-functional team to assist in meeting design controls for Class II Medical Device commercialization• Lead software development team and created requirements to develop, implement, and release user-interface update • Employed necessary updates to allow for pairing and syncing of specific Bluetooth enabled devices within new application Show less

  • Product Manager

    Apr 2021 - now

  • Project Engineer

    Aug 2017 - Apr 2021