Stephen G. O’Neil

P.O. Box ****, Wilmington, NC *8406

Mobile: 248-***-****

acqzt5@r.postjobfree.com

http://stephengoneil.branded.me

https://www.linkedin.com/in/stephengoneil

Professional Summary

Over the course of my career I've had the pleasure to have worked in several capacities, both in representing the Supplier in supporting my customer, as well as that of the OEM perspective, in bringing those same product lines to market. I look forward to my next opportunity as one that would allow me to leverage the background below, in bringing value to initiatives in product development.

Unique blend of expertise in medical device technology in terms of research and development, manufacturing technologies, project management, and supply chain management; while working toward new product release initiatives.

Clinical Laboratory & Medical Device Professional with experience in having worked on cross-functional device teams responsible for bringing 510(K) cleared Class III Devices to a validated market release. These would include product lines representing the Thoracic Lumbar, Anterior Cervical, and Posterior Lumbar regions of the spine.

Experienced with Minitab in having performed Design of Experiments & statistical studies of data compiled during process verification & validation activities. Also strong CAD/CAM background featuring SolidWorks & Unigraphics in having generated the required design and build of CMM & CNC work holding & assembly fixtures.

Professional Experience

Baxano Surgical, Wilmington NC

Senior Manufacturing Engineer (7/13 – 9/14)

While representing new project teams as lead manufacturing engineer, I focused on meeting new product design intent while maintaining manufacturability.

Successfully helped to evaluate, and subsequently determine, the Supply Chain representation in managing a $750K total budget, while leading the effort toward an on-time beta release launch of two new Thoracolumbar Spine Systems.

Engaged the R&D group as manufacturing lead, while evaluating component & assembly designs for manufacture, in conjunction with the subsequent selection of 10 new supply chain partners based on their core competencies.

Strategically managed the supply chain in support of new product development to include that of process validations. Wrote and executed necessary POQ & PPQ protocols, in support of the first fully outsourced release of a system for the company.

Alphatec Spine, Carlsbad CA

Advance Manufacturing Engineer (12/10 – 7/13)

While serving on new project teams, worked with R&D personnel to blend design intent with design for manufacture, while bringing spine system implants & instrumentation to market.

Generated in-house manufacturing work orders in support of new product development initiatives. Also prepared Work Instructions, PFMEA’s, Process Flow Mappings, and Standard Operating Procedures, as required, in support of R&D, in meeting the manufacturing deliverables required of the Design History File leading up to the limited market release.

Through both internal & external manufacturing resources, led new product verification & validation activities to contain that of the necessary IQ/OQ & PQ protocols, and subsequent reports, in the build required of the beta release of product to market.

Once manufactured assemblies & components were received into the quality inspection department, managed expectations moving forward, to ensure the AQL inspection was modified based on the process validation reports, if not eliminated altogether; as in the case of one product line that eventually was the first for the company to have been qualified as Dock to Stock.

Orchid Lansing Orthopedic Solutions, Holt MI

Project Manager (12/07- 12/10)

As R&D project lead, scheduled and initiated contact with the customer base in providing presentations on services to include the manufacturing of their approved product design. From here, would quote the proposed work and track all activity in SalesForce. Upon receipt of purchase order, I led the effort to provide the customer with models & drawings for their approval. Upon approval of the modeled deliverable and project plan, led cross functional teams in providing FA samples and POQ/PPQ validation batch runs.

Application Engineer (06/04- 12/07)

While working in this role of application engineering, developed three prototype CNC machining work cells, while introducing new tools and fixtures as needed. In the process of qualifying the equipment, managed the CNC department leading up to the transfer.

CAD Technical Services, LLC, Fraser MI

Partner (09/96 – 03/04)

Co-founded a startup CAE & manufacturing firm in collaboration with business partner with facilities located in both the US and Scotland. In this partnership, created an engineering design bureau, and went about the business of purchasing design equipment along with printers, scanners and CAD Workstations. Next, recruited, trained and managed the overall group consisting of 12 CAD designers, interns, and machinists in support of our start-up business plan.

Education

Bachelor of Science in Engineering from Wayne State University,

GPA: 3.26, Detroit, MI Major: Electromechanical Engineering

Associates Degree of Applied Science from Macomb County Community College,

GPA: 3.13, Warren, MI Major: Computer Numerical Control, (CNC), Technology

Training

March 2012 Minitab

Factorial Designs, DOE in Practice, Process Validation

Completed 24 hours of training concentrating on the modules above, after completing Basic Minitab review

February 2011 Project Management Institute

Microsoft Project® Methods for the PMM

Completed 12 hours of training on Microsoft Project® emphasizing the Project Management Methodology

January 2011 Alphatec Spine (Web & Classroom/Lab Based)

Initial Product & Sales Training

Completed 40 hours of company product and sales certified training

December 2010 Project Management Institute

Project Management Methodology & Leadership

Completed 24 hours of training in the principles of Project Management

June 2010 Lansing Community College (Onsite Training)

Geometric Data & Tolerancing

Completed 32 hours of training in GD&T geared toward the new ANSI-2009 release

Professional Affiliations

Wayne State University – Professional Order of Engineering Technology, (POET), as active alum since the year 2000

Golden Key National Honors Society (GKNS), active since 1997

Society of Manufacturing Engineers (SME), active since 1994

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