Safety Officer Program Manager

Kenneth Martin Kilborn Move Quickly and eliminate project issues/ team player

Job Related Summary:

· Extensive experience working as a Engineering, Operations, Project/ Program Manager, Process/Product Improvement, Business Analytics

· New product design/Automation

· Program Manager for continuous improvements and cost cutting in Supply Chain, Manufacturing, Engineering, and Regulatory Compliance.

· Experienced in evaluating, auditing and improving on new product designs and introductions (NPI).

· Successfully led a nearly $100M project with a team of several hundred nationwide.

· Current Location: Pleasanton, CA 94588.

· Local Candidate.

· Good communication and interpersonal skills.

· On time delivery

· Extensive Medical Device Experience

· Change Control

Summary:

· Recognized high-performance cross-functional team Leader and Six Sigma Master Black Belt in Manufacturing, Business Operations and Engineering Management

· Accomplished in successfully launching New Global Products and advancements, performing Business Intelligence and Quality Assurance Planning and initiating game-changing Business Transformation projects that minimize expenses

· Passion for launching new products (NPI)

· Known as a process fixer of products and customer complaints

· Readily adaptable to changing business needs within fast-paced global organizations centered on technology and medical products and/or services

· Trusted Partner to numerous key organizational teams, including Engineering, Product Development, Purchasing and Supply Chain

· Program Manager for continuous improvements and cost cutting in Supply Chain, Manufacturing, Engineering and Regulatory Compliance

· Successfully led a nearly $100M project with a team of several hundred nationwide

· As certified teacher/mentor in Lean Six Sigma Master Black Belt (LSSMBB) training, implemented Lean Six Sigma-based scalable improvements to end-to-end operational and manufacturing, teaching and mentoring in parallel with operational best practices

· Led top-tier process and change management initiatives that made direct positive improvements in growth, profitability and operational efficiency

· Ability to turn the complex into simple-to-understand terms

Highlights:

· Leader in NPI, {program Management, 15 years of taking products from concept through launch and post launch

· Received coveted gold and silver awards from J&J, Gold for leading facility effort to ensure zero impact to PC and server performance across all facilities, including business continuity

· Redesigned a dysfunctional shipping and receiving process for Lean flow, improving cycle time 25%, eliminating the constant battle for space, running like clockwork and turned morale from atrocious to copasetic

· Decreased process safety issues by 50% with deployment of compulsory practices and procedures, including stopping the spate of weekly fires by finding and cutting off the fuel source

· Designed and built a new technology-based manufacturing line from empty room through product release, as part of a rollout of a medical device to wipe out childhood blindness

· Built the entire manufacturing area, which included a cutting-edge camera system that touches the baby’s eye to locate indicators to catch diseases early

· Secured FDA and ISO approvals and sold devices worldwide

· First to introduce product software validation concepts to Mattson, building the system and teaching the benefits. No one expected to pass the audits. Met with every VP and trained the entire company, with 100% passing ISO. Major customers included Samsung, Sony and Canon

· Performed value stream mapping of global manufacturing sites to optimize operational processes for the first time, for three organizations: Phoenix, Bio-Rad and Mattson

· Streamlined the lengthy process for sending new products through the pipeline and out the door by overseeing new NPI process design, working on current and future states of each step to deliver 20% faster cycle time (Kaizen)

· Conducted Lean Six Sigma Champion training for division staff of 300+ in Sales, Manufacturing, Engineering, Finance, Supply Chain, Regulatory and Quality, as well as overseas personnel in Belgium, Germany and France

· Developed and rolled-out new Risk Management Process across multiple divisions at Bio-Rad

· Delivered 50% reductions in corrective and preventable actions (CAPA), non-conformance reports (NCR) and human error, for which formally recognized at Town Hall event

Leadership

· Known as an inspirational and innovative goal-oriented leader of integrity focused on forward-thinking solutions. A team champion with a people-first thinking, coaching and training focus. Demonstrated patience and ability to win consensus with teams of all sizes around the world.

· Sense of humor in delivering high-level presentations. Decisive leader of high emotional intelligence, an easygoing manner and a calming influence who easily works with and relates to all personality types at all levels, breaking through barriers and engendering mutual respect.

· Hands-on non-micromanager who is readily available for support on all fronts, engaging with staff each day with a walkaround management style, expressing caring and interest in people on a personal level.

· Devoted time in guiding employees at risk of termination into top sought-after team producers.

Areas of Expertise:

NPI, Program Management, Plant Operations Management, Business Analytics, Continuous Improvement, Auditing/Best Practices, Management Best Practices, Packaging, Quality Assurance Initiatives, Team Building and Leadership, Data Analysis, Organizational Optimization, Logistics (Shipping and Receiving Processes, Mapping), Value Stream Mapping (Current and Future State), Process Improvement Project Management, Plant Financials, Capital and Expense Budget, Full P&L, Plant Upgrade Management, Site Validation, Lean Six Sigma Training, Process Risk Management, Risk Management Program Development

Select Accomplishments:

Thermo Fisher Scientific Mattson Technology

· Implemented a new Manufacturing Execution System (MES) as interfaced with SAP

· Led facility in third party audits preparation and execution (Project cut short due to Covid and complications)

Mattson Technology

· Program Management, Business Analytics

implemented a new Manufacturing Execution System (MES) as interfaced with SAP

· Led facility in third party audits preparation and execution

Angelica:

· Program Management

Responsible for all NPI activities, Business analytics

· Designed, managed and rolled out a large-scale continuous improvement program across the entire manufacturing plant facility

· Spearheaded the complete overhaul of engineering and maintenance practices

· Facilitated all critical plant upgrades and improvements in logistics, manufacturing, EH&S and facilities

· Orchestrated all quality assurance initiatives for the entire facility

Phoenix Technology Group:

· Directed and led an innovative continuous improvement program impacting the entire manufacturing organization

· Designed, built and validated end-to-end net-new process for medical device launches

· Evaluated, audited and improved on new product designs and introductions (NPI)

· Launched project management initiatives for securing cGMP, FDA and ISO 13485 certifications

· Created and implemented essential design and document control guidelines, Business Analytics

Bio-Rad:

· Named Department Head for both Manufacturing/Process Engineering and Validation Engineering

· Applied Lean Six Sigma and operations expertise to select essential resources in support of new product introductions, sustainable engineering, validations and cross-functional projects

· NPI, SAP

· Initiated continuous improvement programs in support of value streams and developed organizational leaders focused on continuous improvement

· Taught and mentored in Lean Six Sigma Methodology

· Developed process risk management standard operating procedures for all value stream and quality program assessments and mitigations

Certifications:

Lean Six Sigma Advanced Master Black Belt Certification

VILC146307 Certification - Villanova University

Project Management Professional - PMP Certification training

Factory Physics - Northeastern University

Radiation Safety Officer - University of Texas, San Antonio

Professional Experience:

Thermo Fisher Scientific, Pleasanton, CA Nov 2021- Feb 2022

Program Manager

Mattson Technology

· Implemented a new Manufacturing Execution System (MES) as interfaced with SAP

· Led facility in third party audits preparation and execution

Mattson Technology, Fremont, CA April 2018 - May 2021

Operations Consultant

· Managed high-profile ISO 9001:2015 audit as internal Program Manager and Mentor

· Audited and offered solutions in NPI process

· Lead plant in complex Reliable Business Alliance (RBA) preparation and auditing

· Perform essential business analytics and business intelligence, digging deeply into plant Procedures and Policies and Work Instructions

· Program Manager for new Manufacturing Execution System Rollout

· Manufacturing Engineering Process Improvements

· Continuous improvements in supply chain (cost cutting)

· Shipping and Receiving improvements, design and build-out of new process

· Create operations current and future state value stream maps

· Prepare and communicate plans for improvement to executive staff

Angelica, Pittsburg, CA 2017 - 2018

Sr. Program Manager

Phoenix Technology Group, Pleasanton, CA 2016 - 2017

Operations and Manufacturing Manager

Kilborn and Associates, Pleasanton, CA 2013 - 2016

CEO - Engineering, Lean Six Sigma, Operations and Manufacturing

Founder and Owner of firm focused on project management, validation, safety, process efficiencies and creating continuous improvement environments for short-term contracts for such major clients as Genentech, Medtronic, Intuitive Surgical and Fresenius.

Bio-Rad Laboratories, Hercules, CA 2006 - 2013

Manager (aka Dept. Head) - Manufacturing Engineering and Validation Engineering022

· NPI

· Chaired the Operational Excellence Program and Lean Six Sigma steering committee including project selections and complete oversight of initiatives

· Trained and mentored in Lean Six Sigma

Kyphon Inc., Sunnyvale, CA 2004 - 2006

Six Sigma Program Leader

· NPI

· Led the Lean-based redesign of manufacturing and new product introduction processes

Johnson and Johnson, Milpitas, CA and San Angelo, TX 1991 - 2004

Sr. Operations Engineering Manager

Technical and Operations Process Leader

Education and Certifications:

Master of Business Administration — Angelo State University (San Angelo, TX)

· Received nomination as Graduate Student of the Decade, placing 2nd

· Served as Adjunct Professor in MBA Program for two years while working fulltime

Bachelor of Science (BS) -- Biomedical Engineering Boston University, MA)

Published Articles:

· Harvard Medical School and MIT -- “Increased Respiratory Frequency and Variability in High Risk Babies Who Die of Sudden Infant Death Syndrome” — Pediatric Research 22(2):158-62 · September 1987

· “Analysis of Heart Rate and Respiratory Patterns in Sudden Infant Death Syndrome Victims and Control Infants” — Pediatric Research 20(7):680-4 · August 1986

· “Assessment of autonomic function in humans by heart rate spectral analysis” — American Journal of Physiology 01 Jan 1985 248.1.H151

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