Supply Chain Medical Device

● Six-Sigma Black Belt ● Lean Manufacturing ● ISO 9001 / ISO 13485 ● FDA ● Purchasing ● QA

● Project Management ● Process Design & Validation ● Supply Chain Management ● QMS ● ERP

PROFESSIONAL EXPERIENCE

Medical Device Business Unit Manager

Polygon Composites Technology – Walkerton, IN – September 2022 to December 2022

Business Unit leader for an international Medical Device Manufacturer.

Overhauled a 3-shift, 50-person International Business Unit with annual revenues of over 50M.

Implemented new SOPs for the Medical Unit per ISO and FDA requirements for all processes.

Slashed international late lines by 64%.

Processed 4 R&D projects through first article inspection, validations, and into mass production.

Trained team on new 5s and Lean protocols to increase efficiency, traceability, and reduce process variability.

Championed Kaizen KPI boards, and led daily Gemba walks to track performance in the Unit.

Director of Manufacturing Operations

Serim Research Corporation - Elkhart, IN – January 2016 to October 2022

Operations leader for an International Medical Device Manufacturer.

International Supply Chain Director, validated all new suppliers per ISO regulations and QMS.

Head of Purchasing for all product lines and raw materials. Analyzed Supply Chain using risk mitigation strategies to diversify vendors leading to a 20% decrease in raw materials costs.

Reduced inventory by 27% freeing up $362,000 for capital investments.

Directed all aspects of Production including: scheduling, SOPs, onboarding and team training.

Successfully drove QA, Engineering, Supply Chain and Manufacturing processes to increase profitability by 19% per unit on average.

Delivered as Project Manager for numerous projects including: UDI labeling system per 2016 FDA mandate, trial manufacturing, and new customer acquisition.

Converted new packaging designs to maximize profitability, efficiency and customer satisfaction.

Introduced and implemented Lean / Six-Sigma leading numerous effective Kaizen and 5S events.

Decreased customer complaints by 62% through training and new SOPs.

Manufacturing Manager

Serim Research Corporation - Elkhart, IN - September 2014 to January 2016

Delivered monthly production schedule reducing down time by 25%.

Validated all equipment and processes to increase production capacity by 100%.

Completed new hire strategies to develop team members after legacy employees retired.

Implemented incentive programs for reducing non-conformities and quarterly retention bonuses.

Led the team to reduce non-conformities and corrective actions by 42%.

Acquired additional roles as head of Purchasing, Logistics and Vendor Management leading to a promotion to Director.

Maitland Engineering - South Bend, IN - June 1999 to July 2014

Production Manager/Plant Manager

Production Manager of a multi-facility, 60+ person team, responsible for a 5-fold increase in production of surgical implants. Key member of leadership group credited with exponential company growth in revenues, multiple facility expansions, and an increase in employee headcount spanning a 15-year career. Analyzed daily production data to establish and ensure individual and team production goals were met. Responsible for all aspects of production, quality, scheduling and talent development.

Optimized cross functionally to analyze and identify real and potential process deficiencies, using Lean Manufacturing, World Class principles, and TPM to reduce waste and streamline production.

Navigated my department through numerous internal, customer, FDA, ISO 9001 and ISO 13485 audit process.

Delivered on the writing and training of employees for: SOP’s, QMS, SPC, documentation and traceability per ISO 9001/2008, ISO 13485 and FDA regulations for medical device manufacturers.

Designed and implemented cellular manufacturing across multiple production facilities.

EDUCATION

Ivy Tech State College - South Bend, IN - Aug. 2012 to May 2015

Associates of Applied Science in Advanced Manufacturing

Technical Certificate in Manufacturing Operations

Summa Cum Laude Graduate ● 4.0 GPA ● Phi Theta Kappa member

Purdue University (MEP)- 13 Certifications Held Including:

Six Sigma Black Belt ● Project Management (PMS) ● Supply Chain Management

Supply Chain Risk Mitigation ● Lean Manufacturing ● Operations Team Building

Supplier Selection, Monitoring, Evaluation and Development ● Vendor Qualification and Validation ● Total Cost of Ownership

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