Process Development Project Management

MARTY HUDSON

*******@*****.*** Cell: 619-***-**** Bloomington, Indiana 47401

CORE COMPETENCIES: Engineering Management / Process Development / Project Management

Astute, results-driven ENGINEERING LEADER with distinguished track record of integrity, engineering, and operations, with increasing responsibilities in all disciplines in R&D and manufacturing operations. Excellent track record in taking new products from concept through design control, process development through commercial launch. Highly motivated with a demonstrated ability to work independently or collaborate with cross-functional teams in implementing successful solutions to meet customer needs.

Successful in developing proactive engineering teams, while continuing to mentor/coach them to improve their problem-solving capabilities and skill sets. Provide leadership for multiple diverse engineering projects to meet tight deadlines.

KEY AREAS OF EXPERTISE

•Process Design & Validation

•Project Management

•Team Building & Leadership

•Capital Equipment

•Medical Device / Contract Mfg.

•Profit & Loss Management

•Product Design & Development

•Custom Automation Equipment

•GMP Manufacturing Principles

•Six Sigma (Lean Manufacturing)

•FDA and ISO 13485 Compliance

•CAPA / Quality Systems

EXPERIENCE

GENENTECH PHARMACEUTICALS – South San Francisco, California --(Remote Contract) -- Aug 2022 to Present

PROCESS DEVELOPMENT WORK STREAM LEAD: Driving the development of a manufacturing process for a pharmaceutical – ocular implant medical device to treat Macular Degeneration. This project has some unique manufacturing challenges as the product is only about the size of a grain of rice. It then has to be filled with a pharmaceutical agent to treat the disease.

Creating the manufacturing processes to go from primarily hand assembly to automated manufacturing processes on a medical implant that is only about 7mm long with 7 components that are assembled microscopically.

Perform installation qualification and equipment commissioning activities of to assemble and package the product with a sterile barrier seal, apply serialized product labeling information, perform automated quality inspection, and place the sealed tray into a carton and shipper box.

Create the documentation transfer package for new processes including the quality standards, validation protocols / testing, equipment specifications, FMEA’s, documentation trace matrix etc.

Aug 2021 to Jan 2022

KIMBALL MEDICAL SOLUTIONS – Indianapolis, Indiana Resigned to care for mother’s medical needs

ENGINEERING MANAGER: Responsible for all Kimball Medical Solutions Engineering Services:

•Manufacturing Engineering

•Molding Process Development

•New Production Introduction

•Equipment Maintenance (PM’s)

•Automation Engineering

•Calibration

Direct all engineering resources for equipment / process development / maintenance and technical support for Kimball’s Indianapolis facility. This includes the specification, integration, validation and sustaining support for “New Product Introductions”, manufacturing operations and maintenance.

Reduced mold tool validation time by 53% by working with cross-functional teams to leverage data provided from Scientific Injection Molding equipment.

Slashed 62% of the packaging inspection time by utilizing automated inspection technology and a rotary packaging machine.

COOK MEDICAL – Bloomington, Indiana (Cook Group 5 Years)

R&D PROCESS DEVELOPMENT TEAM LEAD. Oct 2018 to April 2021

Responsible for managing multiple teams of engineers to develop new manufacturing assembly equipment utilizing “lean manufacturing principles” and single piece flow concepts. Worked in collaboration with the R&D product development teams to ensure that manufacturability is designed into the product as it is being developed (DFM). Working with cross-functional teams from Marketing, Quality, Regulatory, Safety and external partners, we developed the product design specifications and the manufacturing process flow to ensure a high-quality product and that production capacities are met.

Reduced the number of assembly operators from 115 to 37 by automating and re-defining the process / material flow for drainage catheter manufacturing lines.

Drove capital investment of over $2.8MM to reduce annual production cost by ~$12.3MM within 2.5 years and created an ROI of less than of calendar year.

COOK PHARMICA –PROCESS ENGINEER, Sr. Dec 2016 to Oct 2018

As a CMDO for Drug Substance Manufacturing, it was our responsibility to develop new biologic products and processes as per client specifications. Create a transfer package with appropriate documentation, technical reviews, equipment implementation, validation, and manufacturing SOP’s.

By implementing corrective actions and resolving the weaknesses within manufacturing process / flow, downtime was reduced by 41% in less than a year.

Received a promotion at COOK MEDICAL to Process Development Leader to manage / design / implement manufacturing processes for new products.

BOSTON SCIENTIFIC, INC – Spencer, Indiana

MANUFACTURING ENGINEER, Sr. Coordinating (Manager) Sep 2015 to Nov 2016

Established and maintained Endoscopy business unit engineering resources. By establishing a statistical process control (SPC) system to monitor equipment and the manufacturing Key Performance Indicators KPI’s, we could react to issues before they were out of specification. My team was able to:

Decrease operational cost by $1.6MM for the business unit.

Improve product quality, and labor efficiency by implementing process-monitoring systems.

Identify continuous project improvements and implement lean strategies to deliver an annual 7% reduction in cost of sold goods each year.

MERIT MEDICAL SYSTEMS, INC - South Jordan, UT (Merit Medical 21 years)

DIRECTOR 0f ENGINEERING (San Diego, Ca) Jul 2014 to Mar 2015

Responsible for all engineering goals, resources, project management and process quality initiatives to continuously improve product/process quality and efficient manufacturing methods. This includes New Product Introductions, define the project scope, purchase capital equipment, software validations, manufacturing line transfers, and ensuring adequate production capacities are achieved and facility profit and loss accountability.

As a hands-on Engineering Director, I managed the transfer of an angiographic catheter production line from Texas to a Mexico contract manufacturing facility. Provided training for engineering, quality, maintenance, and the operational staff resulting in an annual cost savings of $ 1.2MM.

Increased production capacity and process flow 37% by re-structuring existing catheter workflows and manufacturing equipment.

ENGINEERING MANAGER (San Diego, Ca) Feb 1994 to Jul 2014

Develop a project plan, along with budgets, timelines, equipment costs, return on investment and potential liabilities for the startup of manufacturing initiatives in a foreign country. This is to verify the feasibility, cost reduction estimates, product on-time delivery and quality levels are achieved as per the project plan.

Provided a cost savings of $4.3MM by transferring 6 manufacturing lines from Utah for start-up of manufacturing operations in Mexico. These lines consist of a variety of manufacturing disciplines from advanced automated equipment to manual processing fixtures.

Achieved a manufacturing efficiency gain of 43% by redistributing the line layouts to refine the process capabilities implementing lean principles and concepts to reduce overall unit costs.

Received a promotion to Director of Engineering for successfully coordinating a new manufacturing facility start up in Mexico.

Additional Experience

Senior R&D / Manufacturing Engineer, Merit Medical Systems, INC - South Jordan, UT.

Manufacturing & Process Design Engineer, Abbott Critical Care Systems, INC - Salt Lake City, UT.

EDUCATION

Bachelor of Science in Electrical Engineering Technology – Weber State University – Ogden, Utah

AWARDS:

President’s Club Member Merit Medical Systems Award (For individuals saving $500,000 in 1 year.)

President’s Award for Outstanding Achievement, Abbott Laboratories (2 Consecutive years).

Employee Excellence Award, Abbott Laboratories.

SOFT SKILLS:

Microsoft Office, Word, Excel, Project, Office, Visio, Power Point, One Note, etc.

Excellent communication skills (verbal and written), / Communicative

Innovative, Driven, Inquisitive, Attention to details

Organization skills, Leadership skills, Multitasking

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