Nicolas Gorman

About Nicolas Gorman

I am a supplier quality engineer at Boston Scientific in the sourced finished medical devices (SFMD) group. I work with suppliers, especially OEMs and contract manufacturers, to resolve quality issues, to qualify the devices they make, and to ensure compliance to ISO 13485 and 21 CFR 820 (especially regarding supplier controls). Previously, I was a component supplier quality engineer at EKOS, a BTG International Group company, through integration into Boston Scientific. Before that, I was employed in the nuclear power industry as a Liaison Engineer at Bechtel Plant Machinery, Inc. There, my responsibilities focused around providing disposition to nonconforming hardware, especially pumps and heat exchangers. Prior to that, but still at BPMI, I was in a Project Engineering type position as Cognizant Engineer, where I was the technical expert on my heat exchangers from design, to production and fabrication, through installation and ultimately equipment disposal.I studied Mechanical Engineering at Duke University for my Bachelor\'s degree, and at Penn State University for my Master\'s Degree, where my research was centered on fluid mechanics and heat transfer, especially nucleate boiling.

Experience

1. Supplier Quality Engineer

   Boston Scientific

   Aug 2019 — Present · Bothell, WA, US

   Reviewed and approved supplier corrective action plans and verification of effectiveness documentation in association with SCARs. Performed supplier quality management system audits to ensure that suppliers’ quality systems meet regulatory, product, and business requirements. Led the execution of supplier quality deliverables and collaborated with cross-functional NPD team to onboard finished medical devices. Generated and reviewed quality plans, agreements, product specifications, component qualifications, design verification/validations, and process validations. Provided technical leadership on multiple concurrent supplier site transfers, ensuring supply continuity of high-volume products. Supported and led value improvement projects reducing manufacturing waste, unnecessary SCIAs, and nonconformances associated with bioburden trending. Implemented preventive CAPA to improve traceability for dual-sourced finished device manufacturers. Supported CAPA team and co-led department training on tracing design risks to process controls and verifying supplier conformance to ISO 14971:2019. Identified and led remediation of compliance gaps within product teams. Mentored new SQEs on SCARs, Supplier Changes, risk assessment, and special topics like Finished devices for manufacture and Microbiology for SQEs.

Education

• Penn State University

  Master of Science (M.S.), Mechanical Engineering

  2012 — 2014

• Duke University

  Bachelor of Science in Engineering (BSE), Mechanical Engineering/Material Science

  2008 — 2012

Skills

• Research
• Heat Transfer
• Microsoft Office
• Mathematica
• Fluid Mechanics
• Labview
• Finite Element Analysis
• Thermal Analysis
• Cfd
• Data Analysis
• Dance Instruction
• Solidworks
• Fluid Dynamics
• Microsoft Word
• Matlab
• Thermodynamics
• Latex
• Microsoft Excel
• Mechanical Engineering
• Swing Dance