Experience

Acclarent

• Medical Device
• 100 - 200 Employee

• Staff Engineer NPI & LCM

  • Nov 2021 - Present



Biosense Webster

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Senior Sustaining Engineer

  • Jan 2018 - Nov 2021



DePuy Synthes

• United States
• Medical Device
• 700 & Above Employee

• Project Engineer

  • Jul 2017 - Jan 2018

• Development Engineer

  • Oct 2014 - Jul 2017

  • Worked as product development resource for supplier transfers, product updates, post market surveillance, and product CAPAs for all currently available products.• Responsible for creating and updating Design Control Plans, FMEAs, product prints, clinical history reports, functional relationship analysis, mechanical testing, and other design control related documents.• Project lead for the assessment and completion of product related CAPAs as well as DHF creation.



Zimmer Biomet

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Development Engineer

  • Sep 2013 - Oct 2014

  • I lead a cross functional team of 8, to review Design History Files (DHF) for gaps in current FDA requirements. • Responsible for creating or update DCTMs, FMEAs, product prints, clinical history reports, functional relationship analysis, mechanical testing, and other documentation needed to close DHF gaps identified. • Working with regulatory affairs to prepare documentation for the submission of a 510k. • As team lead I am responsible for meeting deadlines, delegating work and assessing my cross functional team’s progress. Show less