Summary
Overview
Work History
Education
Skills
Accomplishments
Timeline
Generic
BRIAN WILLIAMS

BRIAN WILLIAMS

ORANGE COUNTY

Summary

Experienced leader in Business Operations with a proven track record with scaling up business and driving outcomes to process optimization to maximize organizational efficiency. By cultivating a culture of operational excellence and continuous improvement, and by promoting a team-oriented approach with a strong focus on the customer's voice. Having a creative mindset and a system thinker that is comfortable identifying problems, coming up solutions and proactively implementing them and going the extra mile to deliver the best possible results. Experienced in Leadership with Excellent Communication and interpersonal skills with the ability to effectively collaborate with and influence cross-functional stakeholders at all levels of the organization. Have experience in building and developing high-performance teams with a proven track record and achieving Business Excellence to eliminate waste & improve margins in marketplace.

Overview

33
33
years of professional experience

Work History

E2E Global Project Manager EUMDR

Johnson & Johnson BWI Med-TECH / Cerenovus Neurovascular
Irvine
11.2022 - 12.2024
  • Strategically and successfully brought an 18-month delayed Products For Resale project to status, ensuring compliance with EUMDR through effective management of labeling, IFU, and RA documents.
  • Established meeting governance, resulting in a 59% improvement in time reduction.
  • Established Continuous Improvement Governance with three sites in Mexico, Ireland, and Minnesota.
  • Fostered strong supplier relationships to expedite the completion of overdue tasks, significantly contributing to the project's success.
  • Provided budgeting with financial oversight, which resulted in CIP savings of $4.5 million for 2024.
  • Analyzed data gathered from different sources in order to provide insights into the current state of affairs related to any given project.

E2E Project Manager - Contract

Edward Life Science
Irvine
03.2022 - 10.2022
  • Led the obsolescence project to success, achieving department goals 4 months ahead of schedule and generating inventory savings of $2.7 million.
  • Successfully launched the Delta DPT Sensor product line to the US market, overcoming a 12-month delay by leading cross-functional teams in engineering, quality, and regulatory affairs.

Project Manager

VYAIRE Medical
Palm Springs
08.2021 - 02.2022
  • Reduced operational costs by $200,000 through the strategic relocation of Class 3 Medical Device Ventilators Line from Switzerland to the US & Mexico.
  • Streamlined medical device operations by integrating 8 work streams into one, enhancing efficiency and productivity.

Project & Operation Management

BBraun Medical
Irvine
12.2013 - 06.2021
  • Lead and developed Team for a new IV solution product launch IV into market with a Capital Investment of 250 million dollar for a fully continuous flow automated IV solution line with 60K liter tanks, blow molders, inspection machines, sterilizers, automated leak inspection, automated label printing on IV bag and automated packing machines with MES system & Ignition Software, achieving a 67% reduction in internal reject rate and significantly lowering production costs from $20.00 to $1:10 per IV bag.
  • Interviewed & Hirer & developed team of 50, including Supervisors, Technicians, Mechanics, Engineers, and QC leads, to manage high-output IV automation lines, demonstrating strong leadership and team development skills, while improving supplier quality and relations.
  • Implemented a micro sampling cost reduction project, saving $1.3 million annually by optimizing cleanroom sampling processes.
  • Increase solution tank Yield from 43,000 to 53,350 liters reduced cost per IV bag by $7.16.
  • Replaced Batch records with MES system & set up KPI for Ignition Software system.

Quality Management

Mag Instruments
Ontario
04.2012 - 12.2013
  • Established a Quality department from scratch, achieving a dramatic reduction in internal reject rates from 70% to 1%, saving a $12 million department investment.
  • Developed and implemented new standards and practices for part quality, resulting in zero customer complaints.
  • Develop and maintain relationships with key partners and stakeholders, promoting a culture of collaboration and information sharing.

Polymer Supervisor

Applied Medical Inc
Rancho Santa Margarita
02.2011 - 07.2011
  • Created an MRB system that significantly reduced non-value add activities by 67%, improving production efficiency.
  • Enhanced tracking visibility from 33% to 100% for all production orders, demonstrating strong organizational and management skills.

MFG / Operation / Planning Specialist & S.M.E. / R & D

Beckman Coulter inc.
Fullerton
04.1992 - 02.2011
  • Served as an SME in developing & launching 10 new product lines, significantly improving part quality, and reducing operating costs in the Life Science and Medical Device Industry.
  • Led technical & quality issue resolutions for blood analysis membrane probes, contributing to a 99.5% success rate in the field & on-time delivery to customers from a 50% product failure rate.
  • Played a key role in a Strategic Planning Team producing 450 million biotech parts per year with a 1% internal scrap rate and zero customer complaints for 5 years, while improving supplier quality.
  • Resolved technical & quality issues with Magnetic Stirs, Capillaries, Reagent Cartridges, Pipet Tips & Racks, Incubators Molecular Properties, Centrifuge Components and 100 product lines.
  • Implemented J.I.T. for supply chain which reduced inventory & Manufacturing cost by 27.5%.
  • Established Bio-Tech & Medical Device Manufacturing Operation with External Manufacture.

Education

High Road Leadership / Mentorship Teachings - Organizational Leadership

John Maxwell Organization
United States
05.2025

Biblical Studies - Biblical Studies

Liberty University
Virginia
11-2011

Six Sigma Green Belt & Black Belt - Lean Six Sigma

Villanova University
Pennsylvania
11-2010

5 Year Apprenticeship of Experience Program - Equivalent to S.T.E.M. Program

Beckman Scientist, Engineers, Planning, Quality, Operation, Lean MFG & Executives
Fullerton, CA
04-1992

Skills

  • Effective Communicator
  • Organization Leadership
  • Project Management
  • Product Management
  • Lifecycle Management
  • Supplier Relations
  • E2E Supply Chain Management
  • External Manufacturing Relations
  • Time Management
  • Cost Management
  • Quality Management
  • Yield Management
  • LSSBB
  • Root Cause Analysis
  • Gantt Charts
  • Timeline Charts
  • 5 Why's
  • Fish Bone
  • 6M
  • F A I
  • Technical Transfer of knowledge
  • Risk Mitigation
  • SAP
  • Microsoft Office
  • MP Outlook
  • Ignition software Implementation
  • MES system implementation
  • Procurement
  • TQM
  • CAPA
  • GDP
  • GMP
  • SOP's
  • MDR
  • SME
  • GXP
  • LCM
  • Batch Records
  • Sterilization
  • Aseptic filling
  • Injection Molding
  • New Product Development
  • New Product Introduction
  • R&D
  • Medical Device
  • Bio Tech
  • Pharma
  • Holistic Health
  • Public speaking

Accomplishments

  • 98% Employee retention rate by Leading by example and establishing trust relationships with Teams and Leadership which creates a positive culture.
  • No Product recall in my entire career, always produce high quality work.
  • Transfer technical knowledge to teams by mentorship and developing teams to take over Leadership & Operation roles successfully in 3 organizations.
  • Lead 4.5-million-dollar cost reduction in operation cost in Mexico & Ireland & USA.
  • Received project behind schedule and relocated Class III Medical Device product line from Germany, Austria & Switzerland to USA & Mexico on time.
  • Products For Resale Project for EUMDR reversed 18 months delay with External Manufacture to meet regulatory deadlines on time and reduced unnecessary inventory builds.
  • Lead obsolescence project to achieve department goals 4 months in advance generating inventory savings of 2.7 million.
  • Lead FDA audit preparation for new division of company, which passed FDA, Health Canada audit with no observations.
  • Reversed failing project of the first in USA of new fully automation IV Solution line from automation solution mixing to automated blow molding to automated filling to automated sterilization with visual system inspection through the entire line to automated leak inspection to automated labeling to automated packaging to automated palletizing. Which saved 250-million-dollar investment which resulted in producing 30 million units per year with only 7 minor customer complaints with a 3% internal reject rate.
  • Reverse a failing department with bad morale to high morale with mentorship and coaching to build up team leadership which resulted in saving a 12-million-dollar investment in new automation and manufacturing equipment with an R.O.I. of 40%.
  • SME in establishing World Class Manufacturing operation for Medical Device & Biotech with plastic molded parts with polymer & Engineering resins with significantly improving part quality with a 1% internal reject rate of 450 million parts per year with no customer complaints for 5 years.
  • Established Bio-Tech & Medical Device Manufacturing Operation with External Manufacture.

Timeline

E2E Global Project Manager EUMDR

Johnson & Johnson BWI Med-TECH / Cerenovus Neurovascular
11.2022 - 12.2024

E2E Project Manager - Contract

Edward Life Science
03.2022 - 10.2022

Project Manager

VYAIRE Medical
08.2021 - 02.2022

Project & Operation Management

BBraun Medical
12.2013 - 06.2021

Quality Management

Mag Instruments
04.2012 - 12.2013

Polymer Supervisor

Applied Medical Inc
02.2011 - 07.2011

MFG / Operation / Planning Specialist & S.M.E. / R & D

Beckman Coulter inc.
04.1992 - 02.2011

High Road Leadership / Mentorship Teachings - Organizational Leadership

John Maxwell Organization

Biblical Studies - Biblical Studies

Liberty University

Six Sigma Green Belt & Black Belt - Lean Six Sigma

Villanova University

5 Year Apprenticeship of Experience Program - Equivalent to S.T.E.M. Program

Beckman Scientist, Engineers, Planning, Quality, Operation, Lean MFG & Executives

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BRIAN WILLIAMS