Stephen O'Neil

Stephen O'Neil Email and Phone Number

Manufacturing Engineer interested in supporting my clients with CAD design & process validations for medical devices. @ SGO Enterprises LLC
Stephen O'Neil's Location
Wilmington, North Carolina, United States, United States
About Stephen O'Neil

**Objective**Assist my customer to develop their Medical Devices with Design for Manufacturing in mind. This assures that with the Verification & Validation activities required, a successful launch of their product is certain.In acting as your "Supply Chain Liaison", armed with the required background in both Supply Chain & Manufacturing Engineering, I can fill this valuable role! This is a critical and oft-missing piece that bridges the gap between your design freeze/clearance and the market launch of your Medical Device.Please contact me for additional information. I have worked for both the Supplier & Designer OEM's, and would love to provide this niche role within your company.**Experience**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 included 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 and assembly fixtures.**Specialties**- Engineering desktop software user of DEFORM simulation software in studying mechanics of materials and Minitab software in performing statistical analysis & DOE during process validations.- Extensive CAD user background in Unigraphics and Solidworks 2013 in support of both Orthopedic Total Joint & Spine.- Project Management to include design intent with regard to manufacturing with the experience in having performed as both a representative of the supplier as well as the customer.

Stephen O'Neil's Current Company Details
SGO Enterprises LLC

Sgo Enterprises Llc

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Manufacturing Engineer interested in supporting my clients with CAD design & process validations for medical devices.
Stephen O'Neil Work Experience Details
  • Sgo Enterprises Llc
    Partner
    Sgo Enterprises Llc Oct 2014 - Present
    Wilmington, North Carolina Area
    I am intent on seeking out opportunities to work with an enterprising company interested in leveraging my cost cutting background in providing product development support during the validation of processes leading up to the launch. In parallel, we perform design for manufacturing activities between ourselves & the customer in sdigitially creating product, with an emphasis on design for manufacture.
  • Baxano Surgical
    Senior Manufacturing Engineer
    Baxano Surgical Jul 2013 - Sep 2014
    Wilmington, North Carolina Area
    Worked primarily in support of R&D on the sourcing of all new product development in satisfying new project initiatives.* 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.
  • Alphatec Spine
    Advance Manufacturing Engineer
    Alphatec Spine Dec 2010 - Jul 2013
    Carlsbad, California
    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.* Successfully helped launch several new implant surgical systems to market, while working in the optimum cross-functional team environment to provide the required manufacturing documentation & in process work to support the DHF.
  • Orchid Orthopedic Solutions
    Project Manager
    Orchid Orthopedic Solutions Jun 2004 - Dec 2010
    Lansing, Michigan Area
    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.
  • Cad Technical Services
    Design & Manufacturing Engineering
    Cad Technical Services Sep 1996 - Mar 2004
    Greater Detroit Area
    Founded a startup CAE solutions firm in collaboration with a business partner located in the US and Alloa, Scotland. Coordinated sales with GM, Ford & their Tier One suppliers, while integrating Engineering and Manufacturing solutions in UG V16-18 and Catia V4-V5 onto multiple automotive platforms. Managed and staffed design engineers in-house and on-site.
  • Savair Inc.
    Cad Manager
    Savair Inc. 1993 - 1996
    St. Clair Shores, Mi
    Responsible for increased growth of the company’s IT mainframe and UNIX workstation support staff. Managed an IT staff of seven technicians and controlled all assignments for: technical report writing, budget proposals, application development and operating system support/installation.
  • Eds, An Hp Company
    Application Engineer
    Eds, An Hp Company 1992 - 1993
    Troy, Michigan
    Successfully installed and maintained approximately 100 Hewlett Packard workstations with Unigraphics V10.* CAD/CAM/IMAN/. Also managed and maintained IBM mainframe clients running off mainframe computers in Plano, TX. Supported the UNIX administrator at this EDS facility in addressing OS related issues within our HP V10 client-server environment.
  • Savair
    Project Engineer
    Savair 1989 - 1992
    St. Clair Shores, Mi
    Coordinated layout and design of automatic and robot mounted resistance-welding equipment on various CAD platforms; including UniGraphics, AutoCAD, and CATIA. Project responsibility required having to direct purchasing, manufacturing and engineering in satisfying the demands of the manufacturing cycle as dictated to by the end customer, GM, Ford or Chrysler.

Stephen O'Neil Education Details

Frequently Asked Questions about Stephen O'Neil

What company does Stephen O'Neil work for?

Stephen O'Neil works for Sgo Enterprises Llc

What is Stephen O'Neil's role at the current company?

Stephen O'Neil's current role is Manufacturing Engineer interested in supporting my clients with CAD design & process validations for medical devices..

What schools did Stephen O'Neil attend?

Stephen O'Neil attended Appalachian State University, Wayne State University, Macomb Community College, Fraser High School.

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