Robert Kai Rounds Email & Phone Number

Santa Clara, CA, US

Abbott Park, Illinois, US

• Design and develop stents, delivery systems, and other vascular medical devices.
• Collaborate with vendors to develop and optimize component designs.
• Develop test methods to characterize prototypes.
• Test 3D-printed iterations of prototypes from SolidWorks files.
• Document results in technical reports.

Somerset, New Jersey, US

• Lead project teams with design input activities, including user needs and product specifications.
• Determined remediation strategies necessary for acquired class III devices to comply to FDA and EU MDR regulations.
• Established traceability between user needs to product specifications, design outputs, and V&V testing.
• Considered anatomy & physiology and usability in design input analysis for vascular closure devices.
• Provided technical insight to core team members.
• Communicated activities and recommendations concisely to upper management.

San Clemente, CA, US

• Represented systems engineering on cross-functional core teams.
• Collaborated with R&D, quality, clinical, manufacturing, and regulatory representatives.
• Led definition-phase activities such as documenting user and stakeholder needs.
• Created and updated risk management files such as hazard analyses, FMEAs, and complaint documents.
• Generated design requirements with input from user needs, stakeholder needs, and risk controls.
• Established traceability between all design inputs, design outputs, and V&V testing using ICU Medical templates and procedures.

West Lafayette, IN, US

• Developed a left ventricular assist device component to simplify the implantation surgery.
• Conducted biocompatibility activities of materials per sections of ISO 10993.
• Refined the clinical need statement through a literature review and gap analysis.
• Referred to and updated a design history file, which incorporated design criteria, subcomponent testing, and prototype verification and validation in vitro and ex vivo.
• Utilized FMEA tables and analyses to identify potential failure modes.

Bar Harbor, ME, US

• Created an electrical stimulation device that induced ejaculation in mice, used to preserve genetic material.
• Researched prior works to construct a functional block diagram of the device.
• Milled circuit boards, ordered electrical components, and attached the components by soldering.
• Tested and analyzed sections of the device on the benchtop using voltage generators, oscilloscopes, ammeters, and voltmeters in order to improve design and produce a user-friendly product.

Honolulu, Hawaii, US

• Designed a collagenase assay protocol to quantify the crosslinking of artificial corneas and their strength against enzymatic digestion.
• Demonstrated the use of the protocol as an analytic method for testing future artificial corneal samples.
• Analyzed data using a colorimetric assay and microplate reader in order to improve the procedure using Microsoft Excel and Gen5 software.
• Prepared detailed lab reports to accurately communicate results.
• Observed building processes and assisted in the creation of artificial corneal samples for R&D purposes.

• Inspected the quality of certain aquatic animal feeds by making sure certain pellets were the right size along with verifying that biological samples were ground fine enough to be tested.
• Measured ingredients to mix and create feeds for research.
• Learned how to use machines that created the feeds.

Bachelor'S Degree, Bioengineering And Biomedical Engineering

Education record