Abhijit Sapre
Engineering Manager - Pre-market Design Quality @Medtronic
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WORK HISTORY
Engineering Manager - Pre-market Design Quality @Medtronic
Lead the design assurance, process development quality engineering and combination product QMS framework teams for next generation electromechnical pumps, electrochemical sensors, and combination products •Developed and grown an organization from a two person team to three teams of several engineers •Work with cross functional leaders to develop and technically focused DQE organization to support product development •Coach and mentor DQEs on aspects of design controls work products through design transfer, risk management, collaboration with technical teams and design for reliability & manufacturability (DRM) techniques to drive product development •Lead quality improvement efforts for various QSR aspects (design controls, defect management, risk management etc.), generate procedures, guidance documents and train the stakeholders to the updated standards • Drive root cause, problem solving, and risk evaluations for product design defects / failures and support systematic improvements •Support external and internal regulatory (FDA, MDSAP, notified body) audits by leading preparation activities, audit backrooms operations, and interfacing with the auditors as an SME for design and development •Lead overall response and strategy for major/ minor deficiencies as applicable by regulatory authorities during submissions Progressive experience in multiple roles as Senior DQE/ Principal DQE/ Engineering Program Manager •Core team quality leader for new product development of continuous glucose monitoring(CGM) products from feasibility through design transfer •Define and execute the quality strategy for new CGM product platforms and integration across various systems •Lead product end to end product verification strategy •Establish Design for Reliability & Manufacturability (DRM) quality metrics and drive the design and development activities to ensure these metrics are achieved •Lead risk management activities to identify essential design outputs and appropriate controls
EDUCATION
University of Southern California
Master's, Biomedical Engineering
University of Mumbai
BE, Biomedical Engineering
SKILLS
ABOUT ABHIJIT SAPRE
Engineering leader experienced in design & development, design transfer, launch and…
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