Experience

Kymanox

• United States
• Biotechnology
• 100 - 200 Employee

• Medical Device Engineer | Team Lead

  • Aug 2021 - Present

  • Support a portfolio of products covering a wide range of engineering, compliance, and commercialization challenges for combination products. • Provide technical support for device commercialization efforts on pre-filled syringe, autoinjector, and various medical devices and combination products. • Lead technical projects to support development and commercialization stages of combination product development. • Develop technical direction and provide project support for design control documentation, risk management activities, design verification and validation, as well as pre-launch readiness. Show less



Tegra Medical

• United States
• Medical Equipment Manufacturing
• 300 - 400 Employee

• Quality Engineer

  • Jan 2017 - Jul 2021

  • Quality Engineering representative on cross-functional teams for all new product development and current product changes. • Author of engineering test protocols and reports (IQ, OQ, PQ) required for validation and verification of new product. • Create all validation associated risk management documentation: pFMEAs, dFMEAs, control plans, manufacturing summaries, contact material lists, measurement system analysis etc. • Revise existing and develop new quality system documentation in order to remain complaint per Tegra Medical SOPs within changing industry. • Manage, assign responsibility, mentor and develop a team of 5 Quality Engineering Technicians. • Perform as CAPA team leader to address systemic issues. • Optimize manufacturing processes to provide sustainable gains in cost effectiveness and product performance through statistical analysis, designed experiments, and procedural changes. • Handle all customer complaints on responsible product. Show less



Boston Children's Hospital

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Biomedical Engineering Co-op Student

  • Jan 2015 - Apr 2015

  Performed preventative maintenance on multiple varieties of infusion pumps, thermometers and other biomedical equipment as needed. Also, along with fellow Co-op student, used hospital blueprints to create accurate guides to IT and biomedical equipment on hospital floors to enhance efficiency. Performed preventative maintenance on multiple varieties of infusion pumps, thermometers and other biomedical equipment as needed. Also, along with fellow Co-op student, used hospital blueprints to create accurate guides to IT and biomedical equipment on hospital floors to enhance efficiency.



Terumo Cardiovascular

• United States
• Medical Equipment Manufacturing
• 500 - 600 Employee

• Engineering Intern

  • May 2014 - Aug 2014

  Designed and ochestrated test method validations for engineering equipment Developed maintenance procedures for medical and assembly equipment Designed equipment parts using SolidWorks Facilitated engineers with projects and testing Designed and ochestrated test method validations for engineering equipment Developed maintenance procedures for medical and assembly equipment Designed equipment parts using SolidWorks Facilitated engineers with projects and testing



Vector Marketing

• United States
• Manufacturing
• 700 & Above Employee

• Sales Associate

  • May 2013 - Aug 2013

  Sales associate for Vector Marketing. Find and develop clientele and sell high end kitchen ware. Sales associate for Vector Marketing. Find and develop clientele and sell high end kitchen ware.