Emma Carabillo Email & Phone Number

Acton, Massachusetts, Us

Acton, Massachusetts, Us

I am a Systems Engineer working on Insulet's exciting automated insulin delivery system. Currently, I play a key role in feature definition and refinement, which requires constant cross-functional collaboration with numerous teams. I serve as the Systems lead for some features, and support others. Many features overlap and share requirements, use cases, and risk items which provides me with visibility to features beyond my specifically assigned work. I write, update, and monitor product requirements and participate in cross-functional reviews of these requirements when necessary. I contribute to continuous improvement initiatives by tagging and categorizing requirements to streamline organization across various Insulet projects. In terms of risk management, I write, update, and evaluate use cases, system hazards, and risk control measures. This involves extensive collaboration with user research, user experience, human factors, quality, clinical, and regulatory teams, as well as other Insulet specific teams who work on the pump and controller hardware/software. As my team works to define and refine features, we evaluate each feature's requirement, risk, failure mode, risk mitigation, use case, and system architecture needs before presenting at feature-ready technical reviews.

Acton, Massachusetts, Us

Investigated normal and abnormal use cases for insulin delivery systems to develop, update, and execute design verification testing of new hardware and software for released and upcoming devices. Authored test cases and protocols before performing test runs and writing reports. Confirmed that product requirements were thoroughly tested to satisfy quality and regulatory standards. Identified and characterized software bugs through ad hoc testing to inform cross functional Systems and Software teams. Mentored new hires and participated in candidate interviews to continue positively contributing to the team’s growth and development.

Center Valley, Pennsylvania, Us

Interfaced with post-launch project teams to provide regular updates on supplier performance metrics, as well as NPD project teams to evaluate, qualify, and on-board both component and OEM suppliers. Collaborated with manufacturing, purchasing, R&D, microbiology, and regulatory on high-visibility sterilizer changes to understand and mitigate production, packaging, financial, and supply chain risks and consequences. Audited, managed, and communicated with domestic and international suppliers of varying sizes and capabilities, implementing quality agreements and change request agreements when required according to OSTA quality systems. Remediated the OSTA ASL as part of a major project by identifying and correcting gaps in supplier files. Issued corrective action requests, monitored root cause and containment activities, and reviewed objective evidence of completion. Tracked these activities for the whole SQE team and maintained updated metrics for cross-site review.

Bedford, Ma, Us

Prepared, performed, and cross-referenced multi-level testing schemes to gather performance data on a new product. Performed routine analyzer maintenance, updates and calibrations, monitored progress, and tracked recurring issues. Kept the product on its release track by increasing data acquisition efficiency and assisted other pre-launch product teams, Systems Engineering, and Released Product Support as needed.

Us

Maintained a stocked and organized laboratory space, communicating with colleagues to ensure the availability of necessary supplies. Continued performing Laboratory Assistant and Summer Intern duties into Fall 2016 once part-time hours resumed. Managed these part-time work hours while maintaining full-time student status at WPI and achieving high grades, highlighting and improving time management skills.

Us

Assisted in finding inhibitors of Ebola replication using a Minigenome system requiring knowledge of mammalian cell culture, vector transfection, and assay development. Investigated the effect of genetic mutations on bacterial resistance to antibiotics through assay development and analysis.

Worcester, Ma, Us

Worked on a nationwide Emergency General Surgery Survey. Compiled surgeon biographical information via multiple databases and contacted hospitals for information. Worked in a team under tight deadlines, communicating with superiors often. Utilized Google Drive and data research skills extensively.

Bachelor’S Degree, Biomedical Engineering

Education record