Operations and Manufacturing Leader/Plant Manager

Summary

Highly adept business leader with a strong track record of successful change management in manufacturing and engineering based organizations. Demonstrated ability to excel in management roles with progressive responsibility. Robust background in all areas of Operations management with over 20 years of experience focused on NPI, Lean deployment, site transfers, cost reductions, and QMS compliance. Energetic, people oriented leader with strengths in engaging, motivating, and coaching others to achieve their full potential.

Professional Experience

Philips Healthcare, Bothell, WA

Emergency Care & Resuscitation/Automated External Defibrillator Device Manufacturer

Director, Operations

2016 – May 2019

Director of Operations responsible for Emergency Care and Resuscitation business unit. Responsibilities spanned Manufacturing Engineering, Test Engineering, Continuous Improvement, Rework, Assembly, Calibration, and Non-Conforming departments totaling 95+ staff. Calm, balanced approach while facing multiple challenges of ship holds, assurance of supply disruptions, and increased rigors of QMS due to ongoing Consent Decree. Thorough understanding of 21CFR820, ISO13485, and EU MDR regulations/standards.

Defined vision, strategy, goals, and KPIs to lead high volume manufacturing of Class III PMA medical devices, while operating under Consent Decree for last two years.

Operations P&L responsibility for >$7.5M annual budget. Delivered 4-5% year over year cost reduction with >10% annual volume growth through CI initiatives spanning yield improvement, scrap reduction, and process simplification.

Primary Operations representative for dozens of audits including FDA, TUV, CSA, and Sector. Subject matter expert supporting front room examination and back room strategy planning. Demonstrated track record of meeting rigorous compliance requirements with minimal findings in all Operations departments.

Successfully implemented and coached employees in Lean deployment utilizing QDIP daily management, VSM, 6S, GMP, and Kaizen bursts across manufacturing departments. Over 85% of staff achieved Lean Basics Philips certification and all management team advanced Lean certified.

Adept at CAPA management and guidance, with senior membership in CAPA Review Board.

Leadership Team sponsor for 5 cross functional Assurance of Supply teams and Engineering Change Review Board. Mentored teams in schedule planning, daily management, QMS guidance, and scope creep. EC throughput increased by 50% and on-time milestone completion by 30%.

Achieved best in class employee engagement survey results for ECR division.

Sr. Production Manager, Operations

2010 – 2016

Sr. Manager of Production responsible for Manufacturing, Shipping/Receiving, Warehouse, Inventory Control, Equipment Technicians, and Rework departments totaling 70+ total staff. Proven leader managing all Operation teams, driving a performance and continuous improvement culture.

Delivered products on time with yields exceeding 97.5% and <0.12% DEFOA rate, while managing volume growth of 50% over the last 5 years.

Managed dynamic production load with emphasis on detection and prevention of production risks and bottlenecks.

Prepared yearly operating budget of over $6M and consistently met AOP.

Developed weekly cross functional production issues meetings, focusing on defect trending, yield & process improvement projects, quality system compliance, and supplier controls.

Reduced rework backlog by 90% through development of troubleshooting standard work, creation of in-line rework line, and Quality Notification process changes.

Successfully led team to relocate plant from Seattle to Bothell with zero interruptions to customer deliveries.

Managed operations transfer of Advanced Life Support product lines from Boston to Bothell, meeting aggressive 7 month schedule supporting PMA submission.

Leviton Manufacturing Company, Inc., Bothell, WA

Networking Solutions Company

Manufacturing Engineering Manager – Network Solutions

2009 – 2010

Managed the Manufacturing Engineering team responsible for new product introductions and sustaining support for tele-communications products. Provided leadership on strategic cost savings, make vs. buy decisions, capital investments, floor layouts, and tactical product transfers.

Program leader for Make-to-Order and Special products.

Performed cost/benefit analysis to determine long term manufacturing strategies and justification of automation.

Developed and implemented facility layout changes to enhance manufacturing flow and increase capacity.

Led regular meetings with Design Engineering during new product introductions focused on design for manufacturability, resulting in cleaner product launches.

Managed cost savings program – annual target $1.5 - $1M.

Supervised 6-person engineering team.

Production Manager – Voice & Data Division - Fiber

2006 – 2009

Production Manager for fiber optic product lines responsible for capacity planning, operator training, ISO and UL compliance, budget generation, and capital investment justifications. Also responsible for cross functional teams supporting quote and order process for MTO/Specials including Purchasing, Planning, Document Control, and Manufacturing Engineering.

Led the transfer of all fiber production lines to facility in Chicago, IL. Responsible for integration and training of MRP Systems, product training, production methods, MRB, Returns, and Shipping/Receiving.

Team leader for MTO/Specials responsible for reduction in lead time on MTO product by 40%, improved price quote turnaround time from 48 to 6 hours, and OTD performance gains from 65% to 95%.

Participated in Lean training through grant with WMS focusing on core product lines. Implemented 5-S culture credited with improved operational and safety performance.

Supervised production staff of 7 assemblers, 1 material handler, 1 QC inspector and a 4 person cross functional MTO/Specials team.

Manufacturing Engineer – Voice & Data Division

2002 – 2006

Manufacturing Engineer responsible for support of new product introductions, product line transfers, cost savings and process optimization.

Led the integration and transfer of a strategic fiber optic company acquisition from Long Island to Bothell.

Supported over 20 new product launches.

Initiated annual cost savings of over $100K.

Haworth Inc., Kent, WA

Office Interior/Systems Manufacturer

Manufacturing/Design Engineer

1997 – 2002

Manufacturing/Design Engineer responsible for sustaining and new product introduction of wood furniture case goods. Implemented $80K in cost savings, developed drafting standards, implemented facility layouts based on Lean principles, and facilitated Kaizen events.

One of three person team responsible for new product line introduction. Adept in AutoCad and ProE.

Responsible for custom order specials, managing process through quote, design, and production.

Upon announcement of plant closure, led transfer activities of all manufacturing in a 6 month time frame.

Education/Skills

University of Washington, Bachelor of Science – Mechanical Engineering

Philips End2End Lean Leadership – Advanced Lean Certification

Team Lead/Group Lead Lean End to End Training Certification – Makato Investments

Six Sigma Green Belt

ERP – SAP and Oracle

Interests

Reading, gardening, volleyball, and motorcycle riding

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