Meghan R Tighe Email & Phone Number

Acton, Massachusetts, Us

Acton, Massachusetts, Us

Cambridge, Ma, Us

Developed and implemented a company-wide framework for managing stakeholder needs and requirements, risk analysis, verification, and validation in Jama Connect. Managed system-level risk analysis for a family of class II medical devices in accordance with ISO 14971: 2007.Managed design input requirements for a family of class II medical devices in alignment with customer and user needs.Developed and executed a compliance strategy for regulatory requirements concerning medical devices, lithium ion batteries and mains voltage power chargers, including IEC 60601-1:2012, IEC 60601-1-11:2015, IEC 62133-2:2017.Managed the design verification process for class I and class II medical devices, including protocol development and execution and training and coordinating technicians. Managed the relationship with external test facilitiesPresented information to customers on a regular basis, and worked directly with customers to help them define and document their requirements and product needs.

Cambridge, Ma, Us

Led the Material Review Board in controlling, investigating and disposing of non-conforming product. Reduced number of open Nonconforming Material Records by 80\% in first 9 months.Led multiple product improvement initiatives to increase device reliability, safety and usability.Restructured and managed the engineering root cause investigation process.Supported the Quality team with ISO 13485: 2016 certification process.Founded a Diversity & Inclusion Committee, led initiative to improve hiring practices, teach inclusive language, and enhance team communication methods.

Acton, Massachusetts, Us

Conducted user and product research to shape users’ experiences with alarms and alerts of Insulet’s artificial pancreas system, Horizon.

Needham, Ma, Us

Worked as teaching assistant/ NINJA for the following classes:Introductory Biology: Fall 2015, Fall 2016Investigating Normal: Assistive and Adaptive Technology: Fall 2016Biomedical Device Design: Spring 2017

Horw, Ch

Designed and executed test protocols for design verification of PaQ insulin delivery device in preparation for 510(k) submission to FDA.

Raritan, Nj, Us

Prototyped a bipolar electrosurgery device: designed, built, tested concepts after conducting interdisciplinary brainstorming session. Resultant concepts are currently being processed for US patent application.

Los Angeles, Ca, Us

Houston, Tx, Us

Researched methods of controlling growth rates of Escherichia coli in microconsortia through time-lapse fluorescence microscopy. Constructed microfluidic devices through photolithography.

Needham, Ma, Us

Arlington, Va, Us

Created and maintained social media accounts for Facebook, Twitter and Instagram. Used the social media presence of the ADA to promote Houston’s first annual Diabetes EXPO.

Bioengineering And Biomedical Engineering

Study Abroad, Anthropology

Cross Registered Student, Medical Anthropology

Education record