Keith Wood

Morrison, CO • 303-***-**** • acp61j@r.postjobfree.com

Summary

Director of Product Development – Senior Program Manager – Director of Engineering

Project Management

Design Controls

Engineering

PMP

Portfolio strategy

Risk Management

Strategic Planning

Manufacturing Transfer

Cross-functional team leadership

Coaching

Resource allocation

Budgeting

ROI Justification

Conflict Management

Experience

General Manager/ Sr. Program Manager 7/2012 – present

Soma Access Systems. Englewood, CO

Medical device innovator combining disposables and ultrasound.

Increased package robustness to >99% by implementing significant re-design, and testing to a higher degree of confidence.

Decreased time to market for replacement needle by 75% by prototyping alternatives, reducing scope, and using a two-tiered product release.

Improved estimated project expenditure by $204,000 by prioritizing market needs, budgeting projected resources, and ultimately reducing portfolio.

Reduced the qualification budget of a new needle project by $12,000 through negotiations with Quality and use of in-house equipment.

Introduced 2 new sterile disposable kits by resolving technical issues, implementing supply chain strategy, and completing full verification and validation.

Removed 3 old document templates that led to streamlined processing of finished product, improved communication, and more flexible functionality.

Successfully qualified 8 new injection molds and 1 finished device manufacturing line by planning and leading contract manufacturer efforts.

Achieved the removal of ineffective contract manufacturer program manager, leading to improved response time, smoother communication, and reduced audit risk.

Program Manager 5/2010 – 6/2012

Baxa Corporation. Englewood, CO

Drug delivery device company focusing on safety and accuracy of liquid drug administration.

Increased manufacturing capacity by 400% by leading qualification of $2.0M of assembly equipment at contract manufacturer.

Decreased project risks by 87% by performing rigorous risk analysis process with project team, then responding to risks with appropriate mitigation.

Improved annual cost of pierced septums by $40,000 by moving pierce process from in-house to supplier with demonstrated capability and lower cost process design.

Reduced prototyping costs for bag adapter by 75% by implementing strategy of single cavity bridge tools in favor of 4 cavity production tools.

Introduced new responsibility matrix that led to 100% more engineering coverage of components and processes and improved accountability for products.

Removed one underperformer in our group, contributing to better team productivity

Successfully added 2 new Japanese suppliers with defined expertise in a critical component by conducting thorough RFP process, demonstrating prototype capability, and holding frequent review meetings.

Achieved the removal of 4 significant problems from issue list through deliberate crisis management, Kepner-Tregoe analysis, and cross-functional teamwork.

Operations Project Manager 10/2008 – 5/2010

Baxa Corporation. Englewood, CO

Introduced new in-house pilot plant for sample production by leading manufacturing team to qualify equipment and establish procedures.

Successfully added 14 new injection molds into production by managing team of suppliers, quality engineers, and designers.

Achieved the removal of 1 underperforming contract manufacturer by selection of replacement and managing move of capital equipment.

Senior Process Engineer – Project Leader 5/2008 – 10/2008

Baxa Corporation. Englewood, CO

Reduced complaints by 95% for loose pump rotors by leading project team to investigate root cause and implement solution.

Successfully added 1 new material for TPN bags by developing relationship with supplier, managing internal verification efforts, and implementing material with no interruption to supply.

Engineering Project Leader/ Supervisor 7/2004 – 5/2008

Gambro BCT, Inc. Lakewood, CO

Blood component technology devices for separation and processing blood.

Successfully added 2 new engineering technicians to staff after justification showed the need to meet market launch deadline.

Introduced innovative RF welding concept, $1.3M of machinery, and steam sterilization process for 2nd generation whole blood processing disposables product.

Senior Manufacturing Engineer 9/2002 – 7/2004

Gambro BCT, Inc. Lakewood, CO

Decreased labor to manufacture blood processing bag by 82% by implementing 2 new cut and punch machines.

Introduced 3 new products and 4 new processes to manufacture Universal Blood Bags, improving manufacturability and product flexibility.

Reduced by $40,000 and 12 weeks the cost develop a manufacturing process for RBC bags by reusing existing dies and implementing processes in house.

Process/ Product Manufacturing Engineer 6/1999 – 9/2002

Gambro BCT, Inc. Lakewood, CO

Introduced 2 novel RF welding techniques for second generation blood processing bag that led to 27% reduction in material cost.

Designed injection molded complex manifold and qualified new $250,000 family tool mold.

Increased process yields on leukoreduction filter from 92% to 98% by implementing and verifying new “smart” ultrasonic welder.

Improved by $100,000 the annual spend on needles by researching, evaluating risk, and selecting new needle supplier.

Reduced QC failures of RF welded blood processing bag from 2 per day to 1 per year with innovative die design.

Education

Master’s Certificate in Project Management University of Denver - Denver, CO

Master of Science in Mechanical Engineering University of Michigan - Ann Arbor, MI

Bachelor of Arts in Physics Pomona College - Claremont, CA

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