Katrina Daley Email & Phone Number

Marlborough, Ma, Us

San Clemente, California, Us

As the core team representative of the systems engineering organization for the largest development effort the company has ever undertaken, I managed responses to the FDA for a 510(k) submission as well as communicate directly to FDA reviewers via a Q-sub call regarding particular deficiencies. Additionally, I piloted a brand new requirements trace report as well as risk control measure effectiveness output based on direct FDA feedback. I also authored a safety assurance case for a new product with branches claiming adequate safety, reliability, clinical relevance as well as others per AAIM TIR 38. I gave work direction to and developed an intern for summer of 2020 including goals and milestone accomplishments. I also, led the design validation effort on a large system of products by enumerating and tracking the coverage of eight main system use cases with over 100 scenarios. I was given the opportunity to participate in a clinical immersion program which entailed shadowing surgeons in the operating rooms for a week observing how our products are used in the hospital. I worked with Service and Repair team to develop field replaceable unit procedures to publish in the Technical Service Manual in addition to preventative maintenance procedures. I also assisted in planning verification of the User Interface Specification that dictated all of the screens the infusion pump workflow displays. On occasions I collaborated with the human factors engineering team to assist in preparing the protocol for the summative evaluation of a new product as well as actually facilitate the evaluation with clinicians.

San Clemente, California, Us

As a Systems Engineer I, I led the design input review to place over 100 requirements under design freeze and worked with subject matter experts to close out actions in a timely manner. As a part of my responsibilities I participated in cross-functional dFMEA development to establish design control measures identified from failure mode analysis and align with system level hazardous situations. Additionally, I managed requirement change requests after design freeze by leading a change control board of cross-functional representatives to assess the impact of the change. I also planned early design validation work to develop protocols, worked with functional managers to gain the resources needed, held a kick-off meeting to get the team aligned on expectations of the work, and kept metrics on time to completion.

Milwaukee, Wisconsin, Us

Patent engineer in the firm’s Intellectual Property Group. Practice focuses on all aspects of prosecuting mechanical, electro-mechanical, and electrical patent applications and preparing opinions regarding patentability, infringement, and invalidity. Experience in preparing utility and design applications and prosecuting domestic and foreign patent applications through issuance.

Minneapolis And St. Paul, Minnesota, Us

•Manipulate a robot around a landscape using LEGO Mindstrom NXT in conjunction with RobotC programming language by integrating multiple sensors, motors, IMU, and GPS into the robot•Maximized efficiency by delegating tasks and programming sections to group members to meet our final goal•Took direction from Swiss professors and peers to better enrich abroad experience

•Connected with customers to assist them in finding exactly what they needed in the quickest time possible• Counted cash, balanced the cash register, and opened and closed the store unaccompanied•Aided with making orders, tracking shipments, and taking inventory of merchandise

Downers Grove, Il, Us

•Taught children, ages 3-17, the basic skills of gymnastics such as coordination and balance•Educated children on proper use of equipment and safety procedures•Communicated with parents of the children and be able to report their children’s progress