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.• Developed novel test methods to evaluate product performance and confirm specifications.• Lead test method validations for design verification.• Conducted protocols and tests on various equipment in a laboratory setting.• Analyzed and recommend manufacturing inspection dimensions and features on product drawings.

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.• Led requirements management efforts in sustaining change projects to maintain DHF continuity. • Contributed on up to six sustaining and new product development projects simultaneously. • Resolved conflicting constraints between interdependent stakeholders.• Refined product requirements in response to 510(k) submission comments.• Reviewed and approved verification protocols to confirm appropriate testing of requirements.• Analyzed human factors data to rationalize ergonomic design requirements.• Evaluated complaint data to assess on‐market risk.• Educated new employees on the quality system templates and risk procedures.Please refer to the Projects section for specific project details.

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