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Operations Leader

Location:
Fenton, Michigan, United States
Posted:
January 29, 2019

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Elizabeth C. Beck

ac8bu6@r.postjobfree.com

**** ********** *****, ******, ******** 48430

Phone: 810-***-****

PROFILE STATEMENT

I am a results-driven operations leader with 15 years of manufacturing experience including 11 years in the highly regulated medical device industry. Using my BS in Mechanical Engineering I progressed from an entry-level engineer to a director of a Fortune 500 medical device company including participating in remediation efforts and regulatory body inspections. With my MBA I diversified my operational experience by leading a medical device manufacturing facility by transforming it from a job shop culture to one focused on lean principles of flow and waste elimination. Next, I attained an executive management position where I had the opportunity to successfully lead a new business following a divestiture. With this experience, I have demonstrated success in decisively leading multiple organizations to overcome critical and complex business challenges for both small and large companies. PROFESSIONAL EXPERIENCE

TIDI Products, LLC / Domico Med-Device, LLC Fenton, MI TIDI Products is a designer, developer and manufacturer of medical devices focused on supporting caregivers and protecting patients in the acute care and non-acute care markets. In June 2018, TIDI divested the Fenton Facility to the newly-created Domico Med-Device, LLC.

Vice President of Operations June 2018 - November 2018

• Managed the multi-functional team that created Domico Med-Device, which was successful in moving from concept to transacting business in less than 60 days; and became fully-independent from TIDI Products after an additional 120 days.

• Led the executive team in planning sessions to set the strategic goals for 2018 and company strategy for 2019 and beyond using a Strengths, Weaknesses, Opportunities, and Threats (SWOT) analysis.

• Directly responsible for the operations team that manufactured medical devices such as patient positioning aids, radiation protection equipment, and performed contract manufacturing for medical device manufacturers including MRI coils and carbon fiber surgical positioning aids combining for over 700 SKUs.

• Managed manufacturing (including compression forming, carbon fiber layup and finishing, sewing, painting, cutting, machining and assembly), distribution, engineering, buying, planning, scheduling, facilities, maintenance, safety, and environmental responsibilities.

Director of Operations June 2016 - June 2018

• Directly responsible for the operations team including manufacturing, distribution, manufacturing engineering, buying, planning, scheduling, facilities, maintenance, safety, and environmental responsibilities in an organization with over 90 employees.

• Reduced costs by improving productivity 8% in the first year and an additional 10% the second year by implementing a value stream business model through kaizen events to eliminate waste and enable production flow.

• Created a Sales and Operations Planning (S&OP) process to gain better visibility to future demand and make build rate and inventory decisions that improved delivery by 5% two consecutive years.

• Refocused the lean culture from a tool-based approach to a behaviors-based approach to ensure that ideal behaviors and purpose drive the systems and processes.

St. Jude Medical Sylmar, CA

St. Jude Medical was a Fortune 500 global medical device company (subsequently purchased by Abbott Technologies). The company had more than 20 principal operations and manufacturing facilities worldwide with products that were sold in more than 100 countries. Director of Supply Chain February 2015 - June 2016

• Directly responsible for the supply chain functions including raw material planning, procurement and production planning at three U.S. manufacturing facilities: Sylmar, CA, Scottsdale, AZ and Portland, OR.

• Implemented the use of SAP MRP for all raw material planning and procurement in the CRM division.

• Supported the supply chain efforts that launched new products including an MRI Pacemaker (E.U.), CRT devices with multi-point pacing (U.S. and E.U.) and a value tier pacemaker (E.U.). Page 2 of 2

• Achieved a bulk order for five months’ worth of demand within the manufacturing lead-time by working with suppliers to expedite the procurement of materials and operations to redistribute builds and reduce finished good inventory to focus on this order.

• Led the organization through multiple leadership changes by defining a roles-and-responsibilities matrix and communicating to multiple functions of the organization. Senior Manager of Supply Chain April 2014 - February 2015

• Managed over $172 million worth of inventory and reduced inventory by 29% by consolidating inventory locations and putting in place a process to forecast and net out field return units.

• Led a cross-functional team consisting of suppliers, sales, operations, supply chain and quality to address a single source supplier constraint while preventing a negative impact to revenue.

• Led the efforts to transition field inventory to a next generation product by providing a 1:1 replacement of nearly 8,000 devices within the first week of launch. This included pulling inventory back from the field and offering a replacement on the spot without missing any implants.

• Participated in a Food and Drug Administration (FDA) re-inspection in which zero 483s were issued and a site- warning letter (for items not related to production or supply chain) was lifted. Manager of Pacemaker Operations November 2012 - April 2014

• Managed the planning, procurement and production of the US pacemaker operations with an organization of over 75 employees.

• Increased output by 30% over a three-month period by level loading Kanban levels, process improvements and staggered overtime.

• Led product manufacturing transfers from Sweden to the US and then from the US to Malaysia by supporting the engineering, validation and verification efforts.

• Regarded as the subject matter expert for St. Jude Medical on Device History Records (DHR’s). Led a team to remediate our DHR policy and procedures including redesigning both the content and the context of the DHR.

• Participated in Audits for the FDA, Japan and TUV QSIT audits by supporting the efforts to show objective evidence and presenting to the auditors.

Manager of Product Engineering March 2009 - November 2012

• Managed a department of six engineers with a two-million dollar budget to improve device manufacturing.

• Supported the start-up of a new manufacturing facility in Malaysia through training and resourcing.

• Researched new MES software for use in production and provided recommendations for improvement.

• Organized efforts to cleanse massive amounts of master data in preparation of SAP ERP implementation.

• Manufacturing Change Control Board Member responsible for approving engineering changes. Manufacturing Product Engineer August 2007 - March 2009

• Created routes for the Manufacturing Execution System and launched the software to the production floor.

• Originated new documents to support the Puerto Rico facility’s start-up and supported qualification build on site.

• Prepared numerous documentation and process changes for the manufacturing engineering department.

• Identified and eliminated root cause of poor wire welds and recovered devices from production floor. EDUCATION

California State University Northridge, CA, MBA Management Concentration, Distinction, University Honors

• Consulting Project: Developed a business plan and proposal for funding for a start-up app, MediBabble, through the Rice Business Plan Competition which included a projected ROI.

• Consulting Project: Consulted for the Partners in Care Foundation and provided the foundation with two different strategic directions for the company together with an in-depth business plan on how to execute one of the two strategies.

University of Michigan Ann Arbor, MI, BSE, Mechanical Engineering Magna Cum Laude CERTIFICATIONS

• FDA Title 21 CFR part 820 certified by Association of the Advancement of Medical Instrumentation

• Six Sigma Lean Orange Belt Certification

SYSTEMS & SOFTWARE

Teamcenter (Siemen’s PLM Software), FactoryTalk Production Centre (Rockwell’s MES Software), SAP ECC

(MRP), Master Control Document Management System Software



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