Erin Roberts
Senior R&D Engineer at Cook Medical
- Role
- Senior Research and Development Engineer at Cook Medical
- Location
- Bloomington, IN, US
- LinkedIn followers
- 500 followers
Experience
Senior Research and Development Engineer
Aug 2015 — Present
Product development engineer in the MedSurg business unit, primarily working on Reproductive Health and Critical Care productsResponsibilities include: • Planning project timelines, budgets, resources• Determining user needs & design input requirements• Device design iterations, prototyping, and preliminary testing• Planning and performing design verification and validation testing• Design history file, risk management file, and usability file creation• Supporting global regulatory submissions • Transfers to internal and external manufacturing sites• Global launches bringing new products to marketProjects have included: • Project & technical lead responsible for initial development of user needs and design requirements, product design & prototyping, working with contract and internal manufacturers, planning and executing V&V testing, and regulatory planning for obstetrics device• Project & technical lead responsible for completion of V&V testing, transfer to manufacturing, support for global regulatory submissions and launch of a next generation tracheostomy introducer set • Remediation of 10 design history files with subsequent FDA submissions and clearances• Implemented a lot release testing process in production for IVF products• Project engineer supporting development of a device to support in vitro fertilization (IVF)
Education
The University of Georgia
Bachelor of Science (B.S.), Biological Engineering with an Emphasis in Biomedical Engineering
2010 — 2014
Georgia Institute of Technology
Master's Degree, Biomedical Innovation and Development (BioID)
2014 — 2015
Skills
- Matlab
- Medical Devices
- Microsoft Excel
- Powerpoint
- Engineering
- Management
- Teamwork
- Project Management
- Organization Skills
- Public Speaking
- Autocad
- Product Development
- Sap
- Microsoft Word
- Research
- Team Leadership
- Data Analysis
- Six Sigma
- Biomedical Engineering
- Regulatory Affairs
- Leadership
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