Manish B.

About Manish B.

20+ years of experience in medical device manufacturing, that spans diverse functions including sales, marketing, R&D software development, software quality, and supplier quality.• 15+ years of experience in supplier quality, developing and implementing procedures, deploying ERP and Agile tools, and training teams to ensure compliance and consistency. • 10+ years in people management at two companies (Advanced Bionics, Medtronic)• 3+ years in global supplier leadership at Medtronic, overseeing 15 manufacturing sites across the Western U.S. and Mexico Region.Key Highlights • Led Global Supplier Quality Operations across 15 manufacturing sites in West Americas and Mexico, guiding 100+ professionals in driving excellence and compliance.• Positioned favorably within AOP budget planning, delivering $580K in cost savings YOY while remaining headcount-neutral through scalable solutions and cross-functional leverage.• Drove NCMR reduction initiatives, enabling BO/BL recovery of approximately $8 million within a single quarter - accelerating product availability and enhancing patient service outcomes.• Championed Quality Systems & Regulatory Compliance as a Certified Lead Auditor (ISO 13485, ISO 9001, ISO 17025); ensured alignment with FDA 21 CFR Part 820.• Directed End-to-End Supply Chain Quality including supplier selection, evaluation, qualification, change control, risk mitigation and material management.• Supplier Quality Development Strategy leveraging PPAP, SCARs, Supplier-Owned Quality, and First-Time Quality to elevate performance and accountability.• Forged Cross-Functional Synergy across New Product Development, Sourcing, Operations, Manufacturing, and Regulatory Affairs to accelerate innovation and readiness.• Led Equity & Inclusion Initiatives as Hub Engagement Chair for Men Advocating Equity and Operations Pillar Co-Lead for the Medtronic Women’s Network, fostering allyship and inclusive culture across global teams.• Championed Early Career Development as a USC Brand Ambassador, mentoring aspiring professionals and strengthening university-industry connections.• Architected Global Supplier Quality University, a scalable training platform designed to onboard and upskill Engineers across all Medtronic sites, fostering consistency, compliance, and operational excellence enterprise wide.

Experience

1. Sr Director, Global Process Owner, Supplier Quality Management

   Eli Lilly and Company

   Mar 2026 — Present

Education

• B. M. S. College of Engineering

  BS, Medical Electronics

  1995 — 1999

• University of Southern California

  MS, Biomedical Engineering

  2001 — 2003