Warner Roberts Email & Phone Number

Bloomington, Indiana, Us

- Provide guidance in product development and material selection to ensure device materials meet global material regulation criteria as well as design requirements- Work with various stakeholders to develop and maintain material information databases and material information collection strategies- Help ensure material and device compliance requirements with appropriate standards and regulations- Develop material information guidance documents within company quality system to be used across organization- Collaborate with biocompatibility scientists, material scientists, regulatory scientists, and product engineers to ensure appropriate and timely execution of regulatory submission documents- Assist biocompatibility specialists, toxicologists, and engineers in procuring adequate documentation that will facilitate development of safety/risk assessments

Bloomington, Indiana, Us

I worked with the materials team at Cook Inc. to support material information collecting, material design changes, and regulatory compliance for all devices across cook medical.

I helped implement a new CNC cutting machine for textiles to increase production capability and digitize designs into CAD files for the various products of the company to be produced.

Clemson, Sc, Us

• Objective was to assist Dr. Hannon by managing classes and UPIC interns for the SPIRO institute• Managed the day-to-day activities at the Clemson Venture Accelerator office for entrepreneurs • Moderated classes and coursework for undergraduate students in entrepreneur classes• Managed interns within the program and offered support and expertise help when needed

• Project objective was to design and develop a new internal fixation device for rib fractures• Designed solution to known medical problem using learned engineering principles from coursework• Developed and performed verification and validation plans to meet user needs for potential device including biocompatibility (ISO 10993) and risk assessment (ISO 14971)• Performed 510(k) documentation throughout process and used 21CFR 820 Regulations for Design Controls and QSR• Worked locally and nationally with physicians to explore the problem and develop a better solution• Managed the small team preparing presentations, meetings, and reports to update progress

• Project objective was to design and develop a different type of pneumatic tourniquet cuff for better and safer arterial occlusion of normal and obese patients• Performed extensive research and collaborated with doctors at MUSC to determine a current problem for our team to solve• Created a solution to the problem and developed a prototype to perform verification and validation testing designed by the team• Tasks also included patent searching and filing, market and industry research, commercialization planning, MAUDE and incident research, Risk assessment with ISO 14971, and understanding regulatory pathway• Managed small team preparing presentations, meetings, and reports to update progress

Clemson, Sc, Us

- Team Lead under Dr. Vladimir Reukov designing a macro scale model of an atomic force microscope (AFM)- Designed and built system hardware including framing and electrical circuits and sensing equipment- Wrote MatLab code to analyze and interpret data as well as output graphs for user viewing- Gaining valuable leadership skills and research experience

Clemson, Sc, Us

- Worked in a laboratory setting under Dr. Vladimir Reukov imaging with an Atomic Force Microscope (AFM) system- Used AFM to image surfaces and measured atomic forces acting on surface for various research applications

Burlingame, Ca, Us

- Intern to the electrical engineering department and the - Designed, tested, and implemented wiring harnesses for new products- Worked on product documentation of new and existing systems for production team and customers - Communicated with various suppliers to ensure smooth integration into Proterra designs- Designed and executed tests of electrical systems on the product for evaluation in system remodeling

I worked full time during the summer. I worked on and even led small work crews doing various types of jobs. These included home remodeling, building house foundations, framing, and anything else involved with residential construction. I learned basic carpentry skills along with how to operate certain types of construction machinery and equipment.

Master Of Engineering - Meng, Bioengineering And Biomedical Engineering

Bachelor Of Science (B.S.), Bioengineering And Biomedical Engineering With Bio-Electric Concentration

Education record