Joanne Pelaschier
Staff Quality Engineer @iRhythm Technologies, Inc.
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WORK HISTORY
Staff Quality Engineer @iRhythm Technologies, Inc.
San Francisco, CA, US
Design quality and risk management for Class Ii ambulatory cardiac monitor. Partner with product development, regulatory, manufacturing on next-gen device with new features.DHF remediation. Non-product software assessment and validation.Requirements, tracing, test cases, verification, validation. Phase exit reviews. Templates for deliverables. Data integrity. Electrical, mechanical, software (firmware), cybersecurity within scope.IEC 62304 compliant software development.JAMA for requirements management.
EDUCATION
Yale University
Doctor of Philosophy (Ph.D.)
Rutgers University
Bachelors
UCSC Extension
Certificate Program
ABOUT JOANNE PELASCHIER
I\'m committed to bringing new medical devices and diagnostics to market to better serve human health and well being. I work in the interface between engineering, quality, and regulatory affairs.Engineering, quality, and regulatory affairs are different languages. When I serve on a team, I bring regulatory, quality, and process expertise. I facilitate, translate, and bring out the best in the team and move projects forward. I increase the effectiveness of other engineers by giving them an understanding of how quality and regulatory requirements are based in design control and good business practices. At the same time, I interview engineers and other subject matter experts to determine the potential regulatory impact and test needs arising from proposed designs or changes to existing designs. I love learning new technologies and deepening my understanding of familiar technologies. I am curious about how things work, and willing to dig deep into the details of technologies to best position a project for success through good choices. I bring a process approach to how I execute projects, and I evaluate process for cost and business impact before proposing solutions.What differentiates me from another? I have a bias for execution coupled with attention to detail. I am not afraid to try something new. I am curious and disciplined, curiosity kept in the service of meeting the overall goals.
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