Supply Chain R D

STEVEN HOLLEY

*** ********** **, ******* ** ***** 617-***-****

Results focused leader with 27 years of medical device experience with Class 1A, 1, 2A and 2A devices. Proven leader in solving problems, leading projects, working in challenging multi-departmental changes, driving change throughout organizations, maintaining business continuity, building relationships, and creating system efficiencies.

Strong Communication – Aligning cross-functionally to integrate different backgrounds and teams together to work towards a common goal

Implementing Improvements – Championing ideas and socializing with leaders to harmonize and employ deployment

Financial Acumen – Savvy in reviewing business proposals and costs/benefits anaylysis

Strategic Solutions – Identifying potential gaps in complex processes and developing mitigation strategies

PROFESSIONAL EXPERIENCE

Medline - Microtek Medical

Senior Engineering Manager (Alpharetta, GA April 2020 to Present)

Site Leader for Alpharetta, GA location – 38 Employees: R&D, Finance, Regulatory, Quality, Marketing

Supervising managers and individual contributors in Surgical Portfolio across two countries

o6 direct reports and 9 indirect reports across USA and Dominican Republic

Oversees multiple projects and plans that are managed by the team under my leadership

Identifying manufacturing opportunities and implementing solutions by aligning with quality and supply chain

Leading through ambiguity by cross functionally collaborating to assess project scope, potential loss of revenue, quality risks and margin goals to determine business priorities

Owning updates with senior management with high profile projects on weekly, bi-weekly and monthly meetings

Maintaining strategic OEM relationships (Boston Scientific, Philips, Skytron, ISI, Procept)

Driving vendor support and regulatory compliance for existing and new raw materials

Developing talent by mentoring engineers on project management, specification creation, customer relations and risk assessment

Directing site employee engagement committee

RDE Program Leader (Alpharetta, GA August 2017 to April 2020)

Managed 3-8 engineers to support the Surgical Portfolio across Alpharetta, GA and Columbus, MS

Collaborated with cross-functional leaders to create a ranking system on all potential projects

Developed a communication plan for all sustaining projects to enable discussion into project progress and priorities within the portfolio

Built strong relationships with OEM Account Managers to support and maintain OEM accounts

Led Voice of Customer in the field to mitigate product complaints

Halyard (formerly Kimberly-Clark Healthcare)

Senior NPI R&D Engineer & Project Manager for Digestive Health (Alpharetta, GA May 2010 to August 2017)

Lead New Product Innovation (NPI) projects

oBalloon Dilation - Designed a unique enteral access device through a patented balloon dilation idea and conducted clinical feedback sessions on prototypes

oPEG Kit Redesign and optimization – Led the redesign of the product and packaging to support a $6MM annual product line with a timeline of 18 months from redesign to launch

oPolyurethane low profile feeding tube – Led the design and validation team to allow production of a unique feeding tube to support a $300MM annual product line with a 20-month timeline

Provided field sales and product training support for new products

Supervised protype manufacturing line operations of 10 operators

Managed multi-functional teams from concept to commercialization – Quality, Regulatory, Packaging, Design Engineering, Clinical, Finance, Supply Chain, Manufacturing and Process Engineering

Managed project communication spanning senior executives to hourly contractors to ensure alignment of business and product objectives and project results

Conducted focus groups with clinicians for development of new products through voice of customer input

STEVEN HOLLEY 617-***-**** PAGE 2

Medtronic (formerly Covidien)

R&D Engineer (Chicopee & Mansfield, MA December 2003 to May 2010)

Developed new disposable products in Neonatal, Chemotherapy, Obstetrics, and Operating Room markets

Leader of the core team for launch of new products

Conducted voice of customer for chemotherapy protection line

Supported marketing by executing user studies and writing white papers for operating room positioners

Provided engineering support and conducted design of experiments for manufacturing facilities

Lead a Japanese and USA based team to evaluate the marketplace and to design antimicrobial medical devices

EDUCATION & SKILLS DEVELOPMENT

Master of Business Administration; University of Massachusetts, Amherst, MA

BS in Mechanical Engineering, Minor in Biology; Northeastern University, Boston, MA

Black Belt Certification Six Sigma (DFSS); Covidien

PATENTS & AWARDS

9,339,442 Multi-Balloon Dilation Device for Placing Catheter Tubes

7,665,150 Double-Cuffed Chemotherapy Gloves

D660,431 Cutting apparatus for Medical Tubes

7,866,471 Medical System with Skin Applicator

8,628,497 Safety Catheter

8,568,160 ECG Adapter System and Method

12,564,976 Patent Pending for "Blood Vessel Access Instrument with Vessel Entry Indicator"

6,296,863 Antimicrobial Fabric and Medical Graft of the Fabric

6,585,767 Antimicrobial Heart Valve Suture Ring

COMMUNITY INVOLVEMENT

Eagle Scout 1991

Scoutmaster for Boy Scouts of America Troop 205 (92 scouts) since 2023

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