Oliver Sims

Summary

Over ** years experience as Product Development Engineer/Project Manager in all phases of medical, mechanical and electro mechanical design

Hands on mechanical engineering experience working in regulated and medical device industries

Experienced in New product design and development, existing product improvements and upgrades, conceptual design, design verification, pre-production planning, and providing technical assistance to other areas as needed

Hands on working knowledge with ISO 9001 requirements, FDA, R&D and other regulatory guidelines and standards

Experienced in working with Spine, to add (GUDI) marking to all Class I, Class II and Class III devices that required marking

Required interfacing directly with purchasing, manufacturing, (FAIR) First Article Inspection, suppliers, mechanical test lab, prototype lab, marketing, (FDA) Food Drug Administration, Safety, Intertek Test Lab and all levels of management to develop build and test prototypes for gates leading to production units

Worked in Trauma to remediate documentation gaps from offshore team due to regulatory requirements

Experienced designing (EMS) Emergency Medical Systems and spinal implants and instruments for minimally invasive, posterior and anterior lumbar spine, Trauma and Maxiofacial

Professional Experience

MicroAire Surgical Instruments - Charlottesville, VA May 2016 – Feb 2017

Quality Remediation/ Design Engineer

Remediate findings relating to (FDR) Functional & Design Requirements Class I, II and Class III medical devices in compliance to FDA control regulations (FDA CFR Title 21 Part 820.30, Risk Management activities- IS0 14971: 2012 and EU Medical Device Directive (MDD) 93/42/EEC and Medical Device Regulation (MDR).

Design and Development planning, Design Verification, Design Validation, Design Transfer, Design History File, Risk Management. Creating (IC’s) Inspection Criteria, (AC’s) Acceptance Criteria etc.

All drawings and models designed and maintained using Solid Works 2014 CADD and Solid Works Explorer 2014 Data Manager System.

Stryker Spine, USA - Allendale, NJ Oct 2015 – Mar 2016

Global Unique Device Identifier (GUID) Product Development Engineer/Project Manager

Review redlines, update trackers, create bucket list for (UDI) Unique Device Identifier Requirements, (V&V) Verification Validation, Design and Development Planning, Project Scope Documents, Gate Approvals, Project Gate Dates, Design Reviews, Form, Fit & Function, Regulatory Pathway, Technical Files as required relating to adding (GTIN). Global Trade Identification Number.

Present periodic project status reports.

Assist and provide technical support to cross functional teams, project directors, manufacturing, marketing, purchasing, and regulatory affairs. Requires interfacing with multiple vendors and prototype shop to produce production instruments, plates, screws and implants for Class I, Class II and Class III devices.

All drawings and models designed and maintained using Proe Wildfire 5 and Windchill PLM.

Depuy Synthes, USA - West Chester, PA Sep 2013 – Nov 2014

Global Remediation Quality Plan (GRQP) Product Development Engineer

Remediate findings relating to (FDR) Functional & Design Requirements, (V&V) Verification Validation, Design and Development Planning, Project Scope Documents, Gate Approvals, Project Gate Dates, Design Reviews, Form, Fit & Function, Regulatory Pathway, Technical Files as required relating to findings from offshore team.

Designed and developed medical implants and instrument for Trauma and Maxiofacial.

Responsible for testing production quality prototypes, instruments, and implants with surgeons and cross functional teams in cadaver lab .

Present periodic project status reports. Thoroughly design, apply new technology and materials while reducing costs, improving manufacturability, and assuring quality.

Assisted and provided technical support to other functions of the business such as project directors, manufacturing, marketing, purchasing, regulatory affairs and sales.

Requires interfacing with multiple vendors and prototype shop to produce production instruments, plates, screws and implants.

All drawings and models designed and maintained using Proe Creo and Windchill PLM.

Steris Corporation - Montgomery, AL Oct 2012 – May 2013

R&D Mechanical Design Engineer

Designed and managed (EMS) Emergency Medical Systems spring and motorized ceiling mounted suspension arms, anesthesia heads, columns, shelves to equip with video monitors, oxygen, and various electrical components for operating rooms.

Required interfacing directly with purchasing, manufacturing, (FAIR) First Article Inspection, suppliers, mechanical test lab, prototype lab, marketing, (FDA) Food Drug Administration, Safety, Intertek Test Lab and all levels of management to develop build and test prototypes for gates leading to production units.

Designs consisted of castings, plastics, steel, extrusions and various steel components. All (RA’s) Revision Authorizations, (ECN’s) Engineering Change Notices were created and released in PLM.

All drawings were designed using ProE (Wildfire rlse 4 & Wind Chill PLM rlse 9.1).

Hunter Fan Company - Memphis, TN Jun 2012 – Sep 2012

Mechanical Design Engineer

Designed ceiling fan platforms for domestic and international market, plastic injection molded parts, sheet metal, stainless steel, castings lighting fixtures and various materials for Hunter and Casablanca ceiling fans.

All drawings were designed using ProE (Wildfire rlse 4 & Windchill).

Johnson Controls Inc. - York, PA Nov 2011 – Jun 2012

Piping & Sheet metal Designer

Designed and development pipes and sheet metal covers for Small Tonnage HVAC commercial and industrial units. Coordinate the creation of necessary drawings, Bill of Materials and equipment schedules for submittals and installation.

Demonstrated knowledge of mechanical, electrical, and control systems.

Demonstrated technical aptitude

Demonstrated advanced computer skills required, particularly computer-related drafting tools.

All drawings were designed using ProE (Wildfire version 4) SAP and Pro Intralink.

Synthes Spine, USA - West Chester, PA Oct 2005 – Jun 2011

Product Development Engineer/Biomedical Designer

Design and development medical implants and instrument for interbody fusion and non-fusion groups. Instruments were for ALIF and PLIF instrument sets. Responsible for testing prototype instruments, and implants with surgeons in cadaver lab. Present periodic project status reports.

Work from verbal, sketched and printed documentation input.

Thoroughly design, apply new technology and materials while reducing costs, improving manufacturability, and assuring quality. Assist and provide technical support to other functions of the business such as project managers, manufacturing, marketing, purchasing, regulatory affairs and sales.

Requires interfacing with multiple vendors and prototype shop to produce production instruments, plates, screws and implants for various vertebral bodies.

All drawings were designed using ProE (Wildfire version 2 & version 4) and Intralink.

Medtronic Sofamor Danek - Memphis, TN Oct 2004 – Oct 2005

Custom Biomedical Design Engineer

Responsible for the design and development of medical implants and instrumentation as directed by the business. Custom Rapid team was responsible for quick turn instruments and implants.

Assist and provide technical support to other functions of the business such as manufacturing, marketing, and sales.

All drawings were designed using ProE (Wildfire) and Agile CM rlse 6.1.

Hunter Fan Company - Memphis, TN Feb 2004 – Oct 2004

Mechanical Design Engineer

Designed plastic injection molded parts, sheet metal, stainless steel, castings lighting fixtures and various materials for Hunter and Casablanca floor, desk, table and ceiling fans.

Worked directly with international vendors in China, marketing and sales to assure quality products are being manufactured.

All drawings were designed using ProE (rlse 2001), Pro Surfacing, Pro Sheet Metal, and Pro Intralink.

Viking Range Corp. - Greenwood, MS Oct 2003 – Feb 2004

Mechanical Design Engineer

Celion Networks - Richardson, TX Jun 2001 – Sep 2003

Mechanical Engineer

Dell Computer Corporation - Round Rock, TX Sep 2000 – May 2001

Electro/Mechanical Designer

Optical Switch Corporation - Richardson, TX Jan 2000 – Sep 2000

Mechanical Designer

Trinity Industries Inc. - Dallas, TX Feb 1999 – Jun 1999

Tool Designer

Lucent Technologies - Mesquite, TX Feb 1997 – Feb 1999

Senior Technical Associate

AT&T Bell Laboratories - Mesquite, TX Jul 1995 – Dec 1997

Senior Technical Associate/Assistant CADD Administrator

Thomas & Betts Corporation - Memphis, TN Nov 1992 – Jul 1995

Mechanical Designer: Hubs, Conn, Floor Boxes/Assistant CADD Administrator

Kenworth Truck Company - Kirkland, WA Jan 1992 – Nov 1992

Designer: CAB Structures

Education

Cairn University, Langhorne, PA, 2014-2015

Philadelphia Biblical University, Langhorne, PA, 2008-2010

Mechanical Engineering, Delaware County Community College, Downingtown, PA, 2009

Mechanical Engineering Related Technologies/Technicians, Memphis State Technical, Memphis, TN, 1993-1994

Design and Applied Arts, Richland Community College, Richardson, TX, 1984-1986

Design and Applied Arts, Crowley Ridge College, Forrest City, AR, 1980-1982

Lee High School, Marianna, AR, 1976-1980

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