Engineer Quality

STEVEN WINOKER CQE/CSSBG

** ********** ** ******, ** 10954

917-***-**** (m) ******.*******@*****.***

Experienced Development Engineer (lately in contract jobs) in SolidWorks CAD, FEA and 3D printing as part of cross-functional teams with focus on GD&T, tolerance stack analysis, DFMA, Design for Six Sigma/LEAN, Advanced Product Quality Planning (APQP) and Production Part Approval Process (PPAP). Comprehensive knowledge of medical device manufacturing including cGMP’s, Regulatory Controls and Documentation, Quality Systems, Quality Requirements & Controls, and ISO Certifications.

EDUCATION

Stevens Institute of Technology Jan ’17 – May ‘17

Course - Medical Device Manufacturing

Rensselaer Polytechnic Institute - Troy, NY ‘89

MS, Materials Engineering

Worcester Polytechnic Institute - Worcester, MA 5/87

BS Mechanical Engineering

CERTIFICATIONS & SKILLS

•ASQ CQE – Certification #100059

•ASQ Certified Six Sigma Green Belt – Certification #15192

•U.S. Patent #549627

•ProFirstAid Adult & Pediatric CPR/AED & First Aid - Certification #145************

•SolidWorks, Autodesk Inventor, MiniTab, DFMEA, APQP, PPAP

•American Society of Mechanical Engineers Member #100162708

•American Society of Quality Engineer Member #65200129

•SolidWorks User Group NYC

EXPERIENCE

CONTRACT EMPLOYMENT – C2C’s 09/07 – 05/16

Mercedes Benz R&D (C2C Kett Engineering Corp.), Montvale, NJ (11/15 – 05/16)

Development Engineer - Embedded Software Testing

•Improved turnaround time of Functional and Performance testing of C-class and S-class

•Ran manual and automated software testing follow-up logs with software developers

Siemens Healthcare (C2C Viva USA Inc.), Tarrytown, NY (12/14 – 05/15)

Quality Engineer - Medical Equipment and Devices – Immunoassay 510k

•Led R&D Engineers in execution of design controls, cutting ECO turnaround time by 50%.

•Improved Design Controls by 25% for Design History Files of medical instrumentation using SAP and PLM at Siemens Healthcare within ISO 13485.

•Managed Material Control, controlled BOMs-2D drawings-3D files in SolidWorks and NX.

NYU School of Continuing Professional Studies (1/13–12/13)

SMP Corp. (C2C HY Tech Jobs Corp.), Long Island City, NY (01/12 – 07/12)

Design Engineer - Automotive Aftermarket, Engine and Powertrain Systems

•Re-engineered Nissan EGR Valve with SolidWorks and verification and validation testing

•Developed product specifications and test methods for EGR Valve for Quality and Reliability

Interplex NAS (C2C Kelly Engineering), Northvale, NJ (05/11 – 09/11)

Quality Engineer - Contract Manufacturer, Automotive and Medical

•Conducted injection molding trials and process development with vendors

•Designed fixtures with SolidWorks for Incoming Inspection Report, Control Chart for Pilot Run Plan, and Corrective Action and Preventative Action Plans for medical devices for the injection and micro-stamping lines

Applied Heat Transfer Inc (Independent Contractor) New York, NY (03/10 - 12/10)

Manufacturer’s Sales Rep – HVAC Commercial

•Provided engineering support through technical presentations and lunch & learn sessions of heat exchanger and pump systems to HVAC engineers in NYC.

•Designed layouts and schematics of cooling system proposals to meet several NYC architectural-engineering construction firms requirements for commercial properties.

Professional Development – PMP and NABCEP Solar PV Training (5/08 – 12/09)

Sanford Corp. (C2C ATSI Inc.), Oak Brook, IL (09/07 – 02/08)

Quality Engineer – Consumer Goods, Office Products

•Determined root cause of high defects using Minitab on Prismacolor product line for Design of Experiments

•Developed Corrective Action Plans for Sharpie bleed through resulting in 100% fix.

Cobasys LLC, Orion, MI 01/07 – 07/07

Senior Product Engineer - Automotive Hybrid Battery Systems

•Designed with SolidWorks Mercedes Battery Housing Assembly working collaboratively in weekly design reviews with tooling engineers, Mercedes Engineering and Purchasing

•Coordinated initial design studies using GD&T layouts of electrical system of sensor, relays, wire harness and mechanical for structural integrity and thermal management of battery system resulting in a 25% increase in structural integrity and 15% improvement in airflow.

LEAR Corp., Southfield, MI 12/02 – 01/06

Senior Product Engineer - Automotive Seating and Electronics Systems

•Led engineers in a Program Management role for NPI activities for the 2008 Chevy Savanna and Chevy Tahoe seat system conducting process validation and design reviews with Quality, Manufacturing, Industrial Design, Engineering, suppliers and customer

•Achieved cross-functional experience through business Development working collaboratively on GM Truck Seats with GM PEER Reviews working collaboratively with Lear/GM Team including Complete Seat Engineers, Lear QFD expert, Lear Structures, General Motors Ergonomics Engineer, GM Interior Craftsmanship and Design Studio, GM Engineering and Purchasing

Ford Motor Co. (C2C TAC Automotive), Dearborn, MI 02/02 – 11/02

Quality Engineer – 2003 Mustang Launch, Seats

•Led manufacturing scale-up of the 2003 Mustang Seat line on continuous improvement reducing manufacturing complexity by 50% and a $1.20 per unit cost savings

•Financial experience establishing cost vs. engineering benefit analysis to evaluate suppliers of prototype and production sourcing, working with Sales and Purchasing

Denso International, Southfield, MI 04/00 – 11/01

Applications Engineer – Seat Sensors and Fuel Pump Modules

•Liaison engineer between Japan R&D Headquarters and General Motors in seat sensor software development and physical testing

•Increased sales of fuel module system to $5M by improving flow output by 20%

General Motors & Chrysler (C2C Modern Engineering), Troy, MI 10/97 – 03/00

Design Release Engineer (GM), Supplier Quality Engineer (Chrysler) – Door Systems & Interiors

Implemented continuous improvement Grand Prix Door Reveal Molding for a $300k savings

Led APQP and PPAP with several suppliers and conducted warranty claims for Chrysler Minivan Platform

Johnson Controls Automotive, Plymouth, MI 02/93 – 10/97

Senior Product Engineer - Automotive Seating

Led the program management activities for the DuPont-JCI Thermoplastic Composite Seat reducing part weight by 2 lbs over stamped and rolled-formed frames

Lead engineer development of patent #5494627 for transformation of recycled PET flake into monofilament as a replacement to foam seating

Ford Motor Company – Plastic Products Division, Dearborn, MI 04/90 – 12/92

Product Engineer – Air Induction and Fuel Systems

•Performed design and engineering analysis of engine air induction systems and evaporative canisters for fuel systems on Explorer/Ranger platform along with design validation testing on dynamometer and 6-axis vibration vehicle stand.

•Chief plastic engineer for department conducting material selection, design of experiments, supplier evaluations, process alternatives and capital equipment quotations

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