Ken Iwata Email & Phone Number

United States

Deerfield, Illinois, US

Expanded role to include leading both the site’s Production and Operational Excellence Teams, comprising of over 130 employees committed to Saving and Sustaining Lives

Deerfield, Illinois, US

• Responsible for the site's Operational/Business Excellence Team and Project Management Office at the Irvine Med Device Manufacturing Facility:
• Champion for the site rollout of the Baxter Operation System (BOS) to drive Lean Deploymentand CI initiatives, contributing towards VIP Cost Savings of 5% annually
• Primary Owner of the Site’s Annual Hoshin Strategic Plan to identify key initiatives/projects cross-functionally to support Baxter’s goals to meet SQDCP targets for current year and next 3-5 years
• Deployed new SmartSheets Software (Project Management Tool) to train 20+ Project Leaders, resulting in improved Project Intake/Project Plan creation and establishing a standardized Dashboard/governance process to meet.
• Facilitates identification/prioritization of Project Opportunities through Project IdeationSessions, Money Mapping, Value Stream Mapping, Line Balancing, Kaizens, Standardized Work, Gemba Walks and Ad-hoc Data Analysis
• Leads Site Value Stream Mapping workshops to identify projects opportunities of varying impactand complexity (Breakthrough Objectives, Kaizens, GB Projects, etc); Opportunities would be scored/prioritized in Project.

Deerfield, Illinois, US

Led the site’s Supply Chain Procurement Team

Deerfield, Illinois, US

Led the site’s Manufacturing Engineering & Facilities Team

St Paul, MN, US

• Led the site's Plant Supply Chain Operations Team (end-to-end supply chain from Raw Material Procurement to Finished Good planning) at the Irvine's $500MM+ SVOP Global medical device facility:
• Accountable for establishing/attainment of key Supply Chain KPIs: OTIF, Product Availability, Inventory Dollars ($20MM+), Back Order Dollars, Non-Working Inventory (NWI), Expired Scrap
• Led and developed a team of 5 Supply Chain Analysts and 2 Procurement Analysts
• Champion and lead Supply chain LSS / Continuous Improvement projects, including but not limited to Standard Work, Inventory Turns improvement, Service improvement, Vendor Cost savings, NWI reduction and Value Stream.
• Drive Supply Chain Strategic Planning and Health of Organization discussions to develop targets and direction of developing the team
• Process Owner of Supplier Management Program for the site to help drive continuous improvement/monitoring of our key supplier’s delivery performance, quality and cost

St Paul, MN, US

• Led the site's Lean Six Sigma Program (Operational Excellence) and PMO at the Irvine's medical device facility:
• Achieved >100% to Plant Targets (Cost, Cash, Cycle Time, Growth) consistently, contributing towards > $7.5 million in combined Cost and Cash Savings.
• Coached and helped develop ~25 Division Green Belts to execute and manage projects utilizing Lean Six Sigma, Project Management, Extended Value Stream and Lean Principles
• Led the Continuous Improvement Team, which was in charge of facilitation and identification of Plant Manufacturing/Supply Chain improvement opportunities through Money Mapping, Project Hoppering, Value Stream Mapping.
• Led cross-functional Black Belt Division Projects utilizing DMAIC and Lean methodologies to achieve both Cost/Inventory savings totaling > $500,000/year and Raw Material Lead Time by 15%
• Develop Site Lean Six Sigma Strategic Plan through utilization of key tools such as Hoshin Kanri and Project Bowlers to drive and deliver required savings for Operational Plan

St Paul, MN, US

• Led the 3M Healthcare Business Group VC Process team to gather business requirements and develop a full global implementation strategy of ~$150 million/year in sales for all HCBG generics/custom devices into a future.

St Paul, MN, US

• Led Green Belt Projects to improve cost, productivity and cycle time using DMAIC and Lean Methodologies. Attained total cost savings: > $500,000/year; Reduced focus factory cycle time by 26%; Improved multiple focus.
• Supported 4 New Product launches while working closely with Process Development and R&D to develop and validate new manufacturing processes using statistical analysis.
• Procured and validated multiple capital equipment, totaling ~$2 million, to support capacity, productivity and new product growth projects. Highly experienced in the overall capital equipment cycle: Equipment.
• Provided engineering and technical support for production lines in a cGMP Medical Device manufacturing plant

Newark, Cafilfornia, US

• Authored, revised and executed Batch Records, SOPs, MESs and IQ/OQ validation protocols
• Developed and performed experiments to assess current Manufacturing procedures and practices to improve process efficiency and assess product failure risk.
• Assisted the Process Development group in facilitating process transfer into Manufacturing by creating a more robust system through minimizing contamination risks

Deerfield, Illinois, US

• Directly supported the Blood plasma fractionation process to synthesize life-saving drugs in a cGMP regulated plant.