Sean Carnahan

ad0uzm@r.postjobfree.com• 617-***-****

https://www.linkedin.com/in/sean-carnahan-32352014/

Arlington, TX

Operations Manager

Operations leader with 17+ years experience and strong performance leading diverse engineering teams and growing manufacturing operations. Highly accomplished and success-driven professional with progressive experience in leading business operations, bolstering business growth, and inspiring teams through best practices and strategies. Stellar record of devising and implementing strategic reforms to achieve corporate goals, driving multi-million-dollars revenue, and direct business development opportunities. Skilled in effectively handling multiple projects simultaneously amidst constantly changing variables and priorities.

Areas of Expertise

Operations Management

Standard Operating Procedures

Quality Management Systems

Supply Chain & Supplier Management

Design Control & Audit Support

CAPA Investigation

Manufacturing Engineering

Continuous Improvement

Contract & Relationship Management

Accomplishments

Doubled production output at top US manufacturing site, facilitating launch of Abbott’s BinaxNOW Covid-19 test. (2021)

Drove two significant cost-reduction initiatives yielding total savings of $1.8M in the first twelve months. (2020)

Decreased labeling quality issues with the largest supplier by 80% in (2020) for Abbott Rapid Diagnostics.

Reconstructed organization (2015) by managing out misaligned employees and recruiting top external talent, boosting technical competence, and reducing annual expenses by approximately $150M for Abbott Diagnostics.

Career Experience

Independent Consultant Aug 2022 – Present

Providing short-term consultation for various third-party projects relating to medical device manufacturing.

Key areas of focus have been finalization of product development, manufacturing line design, supply chain setup and vendor qualification.

Quanterix Dec 2021 – Aug 2022

Director, Third-Party Manufacturing Operations (TPM/CMO)

Accounted for the performance of all contract manufacturing partners, cost-reduction initiatives, and business relationships. Created crucial KPI Scorecards for all Contract Manufacturers to identify opportunities for improvement.

Directed inventory management initiative to reduce customer extended downtime by 30%.

Abbott Rapid Diagnostics Apr 2021 – Dec 2021

Interim Site Director, San Diego Toxicology

Accounted for all site operations, approximately 150 personnel, budget for Operations, M&P/GMI delivery. Recognized and supplied 10 and more crucial leadership and production support positions that promote site stability and sustainability.

Acted as the Site Director of Operations during the launch and production ramp-up of a crucial flagship product.

Planned and culminated recovery effort necessitating rework of 2K+ instruments to correct firmware version.

Managed site through numerous launch-critical validation initiatives on-site and at supplier locations.

Third-Party Manufacturing Operations (TPM/CMO), Abbott Rapid Diagnostics Sep 2019 – Apr 2021

Senior Manager

Oversaw the administration of all Third-Party Manufacturing (TPM/CMO) Operations. Accounted for TPM performance, cost-reduction initiatives, and business relationships.

Implemented new TPM performance monitoring metric and Business Review schedules for suppliers. (2019)

Restored 100% on-time delivery (OTD) for all device suppliers during the Covid-19 crisis. (2020)

Oversaw crucial BinaxNOW TPM/CM Operations during launch construction, doubling daily production capacity. (2021)

Instrument Operations, Abbott Diagnostics Jan 2017 – Sep 2019

Engineering Manager

Oversaw critical supplier during the rapid production ramp-up required by Abbott Diagnostic's "Accelerate" strategy for 2017-2019, in conjunction with the introduction of the Alinity product family.

Offered critical site audit support (2017, 2018, 2019) delivered successful compliance ratings.

Increased supply chain efficiency through direct collaboration with Singapore's TPM and key subcomponent suppliers.

Laboratory Automation Systems, Abbott Diagnostics Sep 2014 – Jan 2017

Program Manager

Supervised the product development activities of 14 scientific and engineering professionals with annual budget of $3M.

Eliminated inspection requirement for Abbott ACCELERATOR a3600 (2016), saving clients 1 day of unnecessary work per week.

Abbott Diagnostics Jan 2010 – Sep 2014

Manufacturing Engineer Supervisor

Executed all engineering change notifications (ECN) and process validations. Spearheaded the design, fabrication, and validation of novel high-precision syringe tester for the contract manufacturer.

Oversaw staff of eight engineers, all in-house and outsourced manufacturing engineering activities, and $2M annual budget.

Designed and implemented automated remote system to monitor outsourced product testing in Dallas, thereby decreasing the average time to detect intermittent hardware failures by 30 days.

Led LSS project that decreased design change implementation cycle time for modifications initiated by Abbott and implemented by the contract manufacturer in Singapore by 15 days.

Abbott Diagnostics Mar 2008 – Jan 2010

Manufacturing Engineer

Maintained, improved, and constructed any new automated test systems. Acquired extensive knowledge of Engineering Change Notice (ECN), Design Verification, and Process Validation.

Awarded VP award (2010) for co-leading LSS initiative that reduced cable-related nonconformances by more than 50%.

Implemented LSS 5S in the Dallas Factory in 2009, removing 1000+ superfluous tools.

Developed and executed engineering solution that permanently eliminated product failure mode that led to consecutive Field Actions in 2008.

Additional Experience

Immunochemistry Product Specialist, Field Sales - Abbott Diagnostics

Associate Engineer, Research & Development - Abbott Diagnostics

Education

Master of Science in Biomedical Engineering

University of Texas Southwestern Medical Center/Arlington

Bachelor of Arts in Biology

Texas A & M University, College Station, TX

Certifications

Lean Six Sigma Black Belt Certificate, BMGI, Denver, CO

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