Bruce Lau Email & Phone Number

Irvine, CA, US

North Chicago, Illinois, US

Eye Care portfolio.AI evangelist.

Deerfield, Illinois, US

• Managed annual budget, SharePoint for knowledge share/staff development, and daily tier meeting board. Brought on to support $2MM manufacturing automation upgrade (Extrusion) for capacity increase and defect reduction.
• Identified highest scrap cost in-process checks for statistical process control (SPC) monitoring to switch from reactive to preventive in reducing 11%+ scrap to 0.68% for the highest volume product code.
• Site mentor for management development associate targeting operational excellence through Six Sigma, specifically DMAIC, in value improvement project of $1.1MM cost reduction.
• Ensured execution of quality initiatives and projects; influenced cross functional members through project dashboards (4 panel).
• Created actionable metrics to monitor all manufacturing equipment to reduce operation risks including line down (routine vs. non-routine work orders). Operational risk management.
• Reduced 2020 YTD complaint incidence per million (CIPM) of 1200 to 730 (39% reduction) by executing on process and quality initiatives.

Culver City, CA, US

• Brought on to support starting up a new GMP cell therapy manufacturing facility ($60MM) and improved quality systems for phase appropriate inspection readiness for clinical products progressing through Phase 1.
• Created new team structure to: perform risk management (ICH Q9 and ISO14971) to reduce failures with risk-based approach (FMEA), (ICH Q10) change control that prioritized impact to patient health and/or business.
• Released phase appropriate quality system procedures to improve inspection readiness. Assessed all raw materials for risk-based material inspection and vendor qualification to apply resources where needed.
• Created actionable metrics to monitor all manufacturing equipment to reduce operation risks including line down.
• Responsible for all reviews of validation and requalification studies ranging from cryogenic freezer, bioreactors to analytical instruments.

Tustin, California, US

• Managed all business, operations, facilities, and GMP/ICH compliance risks for $55MM+ portfolio (annual revenue). Senior member in the Project Management Office; supported CEO, Quality, Manufacturing, Supply Chain.
• Loss prevention of $2MM of oncology MAB batch. Assessment protects client revenue and compliance objectives with patient safety in mind.
• Managed engineering projects and reduced COGS by increasing capacity utilization rate of cell banking suites. (30 to 90%).
• Venture and product portfolio diversification through diverse indications (Oncology, immunology, infectious diseases) and client mix (additional late phase clinical clients) analysis for revenue diversification and.
• Successfully supported facility expansion plan to increase manufacturing capacity (1000L to 2000L Bioreactors) with risk controls during construction.
• Manage compliance risk through risk files and risk controls. Achieved US Pre Approval Inspection (PAI) and Turkey PAI with no observations in 2017.

Marlborough, MA, US

• Managed up to nine engineers to ensure V&V testing, Risk Management, SW lifecycle and usability engineering activities for all prostate health new product development ($110MM+ annual revenue). FDA/BSI Inspection.
• Launched four global products: MoXy catheter, Tractip Catheter, StoneLight 30W Laser, XPS Laser RoHS
• Increased MoXy catheter sales by 280% from 2013 to 2014 by verifying and validating the catheter to extend life (650KJ) to allow physicians to operate in bigger (100g+) enlarged prostate with single fiber.
• Performed complaint analysis to find the biggest failures (theory of constraints) for product improvement driving complaint rate from 2.4% to 2% of shipment.
• Led all statistical analysis and empowered team with Minitab 13 for sample size determination (1Sample 2 Sample T, ANOVA, etc.) to ensure reliability level is commensurate with risk.

Marlborough, MA, US

Lead design control activities including V&V, risk management files (ISO14971), Biocompatibility (ISO 10993) studies, Electrical Safety/EMC (60601 3rd Ed), Usability Engineering (HE75/62366), accelerated aging (F1980-7), SW lifecycle management (62304), Process Validation (IQ/OQ/PQ), and Test Method Validation (Gage R&R).

Kalamazoo, MI, US

Brought on to create site Human Factors/Usability program, process and procedures. Lead 4 contractors to complete 63 Usability Engineering Files in 15 months – prevented interruption to $320 MM EU product revenue.Lead global pre-market regulatory filings for video accessories business unit (510k, letter to file, CE Technical Files) including wireless.

Kalamazoo, MI, US

Designed and launched Fluids Seal Adaptor with ProEngineer CAD, GD&T, ANSYS FEM, 3D printing (SLA) and V&V protocol design. DHF completed in 4 months for domestic launch and led to immediate $2MM+ contract Kaiser contract. Worked with contract manufacturer for successful global launch in 6 months.

CA, 92121, US

Tested and designed sub modules for In-Vitro diagnostic blood screening instrumentation (Tigris and Panther) for infectious diseases. Used by American Red Cross.

Master Of Business Administration - Mba

Bachelor Of Science (Bs), Bioengineering

Master Of Science (Ms), Mechanical Engineering