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R&D Product Development Engineer Medical Device Consumer Goods

Location:
White Plains, NY
Posted:
June 29, 2021

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Resume:

Kevin J. Quinn

adnfwq@r.postjobfree.com

610-***-****

* **** *****, ******* ******, PA 19073

PROFESSIONAL EXPERIENCE

FXI – Aston, PA June 2014 – Present

Senior R&D Engineer, Lab Supervisor November 2017 – Present

Lead technical development projects for new polymers and finished products. Collaborate directly with OEM customers to develop specifications for new products, improvements to current products, polyurethane foam formulations, and provide technical service support. Drive concepts to completion from the R&D lab to pilot scale, production trials, and QC qualifications leading to launch. Design test plans to validate solutions based on customers’ desired outcome, and educate customers throughout the process. Analytical support and troubleshooting for manufacturing facilities and customer inquiries.

Manage team of lab technicians and organize weekly priorities for the R&D lab. Built system for tracking and communicating the status and priority of open items for entire R&D group using Smartsheet web app. Implemented automated prioritization algorithm based on importance and urgency.

Developed a portfolio of new materials that enabled onboarding and line extension of several key accounts in the largest and fastest-growing business unit.

Leveraged core technologies from different product lines to create a unique new material for a new customer. Implemented concurrent statistical models to guide polymer formulation to meet specific material properties. Added a new high-margin account that quadrupled volume in the second year post-launch.

Created a method for testing and analyzing mattress composites to quickly screen key performance indicators for correlation to end-user testing

Addressed immediate need for face masks in response to COVID-19. Designed mask and manufacturing process in a small team of engineers, set up prototype tooling, and quickly transferred design to third-party fabricator for mass production. Masks supplied to production facilities to allow safe operation and are commercially available.

R&D Engineer June 2014 – November 2017

Research, new product development, and commercialization of medical support surface products. Coordinate, design, and execute human subject trials and human body analog modeling to quantify performance of support surfaces. Measure/model patient skin microclimate and interface pressure to design for prevention of decubitus ulcers. Implement Design of Experiments (DOE) and statistical analysis methods for processing data.

Built Design History File for Class I medical devices with design control under ISO 13485 and FDA-regulated manufacturing facility. Manage design transfer process, including Bill of Materials, fabrication programs, design verification records, and drawings per standard GD&T guidelines. Active representative for Support Surface Standards Initiative (S3I) committee under NPUAP. ANSI/RESNA-affiliated standards body with representation from manufacturers and clinicians developing performance and reporting standards for support surfaces.

Altus Spine - West Chester, PA January 2014 – February 2014

Orthopedic Design Engineering Intern

Developed CAD models of existing Class III medical devices (surgical instruments and implants) using Creo Parametric 2.0. Worked directly with Design Engineers to develop existing products and create manufacturing drawings for updated revisions. Implemented geometric dimensioning and tolerancing (GD&T) as well as design for manufacturing considerations.

Acero Precision – Newtown Square, PA June 2013 - January 2014

Manufacturing Assistant

Machining for Class III medical devices and automotive parts, working primarily with Star SR-10J and SR-20R CNC lathes

LEADERSHIP & ACCOLADES

FXI Innovation Team Award – 2014, 2015, 2018

EDUCATION

Johns Hopkins University – Baltimore, MD May 2014

Bachelor of Science, Mechanical Engineering

oExtracurricular: Varsity Football, Vocal Chords A Cappella

SKILLS & COMPETENCIES

CAD: SolidWorks, Pro Engineer, Creo Parametric

Statistical Data Analysis: Microsoft Excel, JMP, Minitab

Manufacturing & Prototyping: 3D Printing, CNC, Laser cutting, machining, polyurethane synthesis

Other: Kepner-Tregoe Problem Solving & Decision Making



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