Bruce Lau

About Bruce Lau

I am a seasoned leader in the Medical Device and Biopharmaceutical industries, currently responsible for a $1.7B+ global product portfolio. My career has been defined by the ability to balance engineering expertise, business acumen, and emotional intelligence to drive growth, launch breakthrough products, and resolve complex regulatory challenges.Career HighlightsLaunched 9 global medical device products with Stryker, Boston Scientific, and Hologic.Delivered 2 clinical drug substances (mAb and cell therapy) with start ups, OTC & RX drug products, and 16 EU MDR-certified combination devices with AbbVie.Led reliable production of 4 million+ infusion pumps annually at Baxter, achieving consistent year-over-year cost reductions.Successfully remediated FDA 483s and warning letters, ensuring compliance while sustaining business momentum.Drove global innovation by influencing cross-functional teams to deliver new devices, drugs, and combination therapies.Advanced operational excellence using Lean Six Sigma, data-driven strategies, and intuitive presentations that secured adoption of high-value programs.MissionTo deliver statistically rigorous, high-ROI programs that increase revenue, delight customers, reduce COGS, and maximize net income — all while shaping the future of healthcare through innovative products and solutions.Certifications:Certified Manager of Quality/Organizational Excellence (CMQ/OE), Six Sigma Lean Black Belt, and specialty in DFSS (design for six sigma), PMP Project Management Professional* Capital equipment * Single use sterile disposable * SW validation (Part 11 CSV and IEC62304 * Medical Electrical Equipment * Electrical safety 60601-1, EMC 60•••12, Laser safety 60••••22 * EO terminal sterilization * ASTM F1980-7 accelerated Aging, Shelf Life * ISO10993 biocompatibility * Minitab 17 Statistical Analysis * TIR12, TIR30, ST79 Reprocessing * SPC Statistical Process Control * ISTA Storage and Transport * IVD alpha and beta Risk * Risk Management ISO14971 * HIT Risk * FCC Wireless * CE Marking * 510K US clearance * HE75, 62366-1, 62366-2 Human Factors, Usability * PMBOK Project Management * Lean Six Sigma

Experience

1. Senior Manager, R & d Quality - Combination Products

   AbbVie

   Mar 2021 — Present · Irvine, CA, US

   Eye Care portfolio.AI evangelist.

Education

• USC Marshall School of Business

  Master of Business Administration - MBA

• UC San Diego

  Master of Science (MS), Mechanical Engineering

• UC San Diego

  Bachelor of Science (BS), Bioengineering

Skills

• Ista
• Cross-Functional Team Leadership
• Iso 14971
• Kepner-Tregoe
• Risk Management
• 510 K
• Quality System
• V&V
• Sas Programming
• People Development
• Design for Manufacturing
• Human Factors Engineering
• Corporate Finance
• Iso 10993
• Biocompatibility
• Shelf Life
• Medical Devices
• Capa
• Fda
• Design Control
• Ansi Y14.5
• Dfmea
• Sterilization
• Autoclave
• Iec 62304
• Configuration Management
• Pfmea
• Ansys
• Project Management
• Qsr
• Business Analytics
• Validation
• Pro Engineer
• Inbound Marketing
• Weee
• R&Tte
• Iso 13485
• Iec 60601
• Employee Engagement
• Astm Standards