Director, Manufacturing Operations

WILLIAM (Billy) A. ENGLE

***** ********** ***, ****** ****, California 95037

408-***-**** • ********@*****.***

Twenty six years in key leadership roles spearheading continuous improvement campaigns with a medical device company. Professional that has progressively advanced through the organization with a proven track record of generating growth and achieving objectives.

WORK EXPERIENCE

Hospira, Inc. (spinoff of Abbott Laboratories in May 2004)

Director, Device Operations San Jose, California

October 2011 – Present

Was asked by corporate executive management to temporarily (24-36 months) be responsible for the operations function of the device remediation team, which has an overall budget of ~ $400 million and has been declared by the CEO as the number one program for the corporation. Responsible for providing direction and managing resources for root cause investigations and providing technical remediation options to the corporation which will include product redesign of on-market products. Assist in the development of preventative maintenance programs and administer modification to documentation on all marketed product. Being asked for this critical role was based on the passion for the business and the extensive life-cycle knowledge of the product through exposure to several functions over the years. Continue to provide guidance to the interim plant manager of the San Jose facility.

Director, Manufacturing Operations Morgan Hill, California/San Jose, California

February 2002 – September 2011

Provided leadership and direction to a regulated medical device manufacturing, distribution, engineering, return goods processing and support services functions such as accounting, human resources, and quality assurance in order to achieve short and long term strategic objectives. Total facility responsibility encompassed approximately 40 salaried employees and 550 hourly personnel. Also responsible for factory level service centers/plants in Canada, Australia and Ireland which provided world-wide service of serialized medical devices. Demonstrated achievements in continuous improvement through use of business practices such as lean manufacturing, six sigma, total value management and business operating systems. Led the charge to transform the plant to lean manufacturing. Led performance improvement efforts across all functions and developed high performing teams resulting in expanding individual and organizational capabilities. Provided support for ensuring, improving and maintaining plant’s compliance to FDA, GMPs and Quality System regulations, ISO, and other requirements. Demonstrated a strong background in preparing and managing budgets and monitoring key plant P&L financial indicators. Successfully transferred new production to another offshore company location and relocated California operation to a new facility location.

Abbott Laboratories

Program Manager Abbott Park, Illinois

January 2000 – January 2002

Responsible for coordinating efforts across several plants and many different cross-functional organizations to investigate and resolve significant product performance issues on devices in the field. Developed a strategy that established multi-discipline teams and set direction to address major customer concerns and complaints. Was successful in driving issues to resolution within a short period of time and was recognized by corporate executives on a job well done.

Sr. EDDS Specialist & Account Manager (Sales) Little Rock, Arkansas

May 1998 – December 1999

Managed a sales territory that supplied hospitals with products from anesthesia to drugs and electronic drug delivery systems. Exceeded goal expectations for the sales territory from the start. Established strong business relationships with customers in Arkansas and eastern Oklahoma. As a Sr. EDDS Specialist, the sales district was number one in the nation for selling more devices than any other district in the country. As a Sr. Account Manager, was awarded National All Star for achieving top sales (7th in the nation).

Manufacturing Business Unit Manager Morgan Hill, California

October 1996 – April 1998

Managed the day-to-day manufacturing and servicing activities for several medical devices while maintaining a close relationship with the customer, field service and sales. Worked closely with R&D and other functional organizations in the launch of new products in addition to supporting legacy products. Managed and lead activities of those with and without direct reporting responsibility. Developed and implemented several new improvements for the field, significantly improving product cost and customer satisfaction levels.

Southeast Field Service District Manager Birmingham, Alabama

April 1991 – September 1996

Provided direction and managed twelve field service representatives (FSRs) as well as worked with customers in understanding what continuous improvement programs could be considered to improve overall service and support of Abbott products. Coordinated with district sales to develop and maintain a team approach to customer communications that improved customer perceptions and market share. Successfully developed and implemented a detailed FSR quality compliance program used throughout the nation that assures FDA compliance within the organization.

Senior Field Service Representative Atlanta, Georgia/Birmingham, Alabama

February 1986 – March 1991

Provided responsive repair service and instruction of company’s infusion devices through on-site account service. Extensive experience in listening to the customer and troubleshooting with various departments like Nursing and Biomedical Engineering on the performance of devices. Developed a strategy to start up a device repair depot in the Southeast which led to opening other depot locations in Dallas and Los Angeles. Key activities were developing and implementing procedures that met FDA and ISO guidelines. Provided leadership to personnel at two other U.S. locations on the set-up and operation of the program.

Lakeshore Hospital Lake City, Florida

Biomedical Technician October 1984 – January 1986

A one-man biomedical department, performed repair and preventive maintenance on various manufacturers’ equipment within the facility. Developed a preventive maintenance program that decreased overall equipment downtime. In addition, played a significant role in new equipment evaluation and purchasing decisions.

EDUCATION

Bachelor of Science in Management, University of Phoenix – GPA 3.94

Associate in Biomedical Electronic Technology, University of Alabama-Birmingham

Six Sigma Green Belt Certification – May 2006

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