Mihir Shah
Product & Clinical Engineer
- Role
- Senior Engineer Ii, Product & Clinical Affairs at Infusyn Therapeutics, Llc
- Location
- New York, NY, US
- LinkedIn followers
- 500 followers
About Mihir Shah
Passionate professional with several years of experience in Engineering, Medical, and…
Experience
Senior Engineer Ii, Product & Clinical Affairs
May 2024 — Present · US
Retain all responsibilities from previous role as Senior Clinical Engineer (details below)• Manage Product Engineering and Surveillance Operations and support rebranding efforts from Flowonix to Infusyn • Collaborate cross-functionally, overseeing ongoing recalls, trials, and studies with the Head of Regulatory Affairs. Submit adverse event reports (MDRs) to the FDA and international regulatory bodies to ensure proper compliance • Direct the global customer complaint intake process and lead weekly meetings to track and analyze trends• Evaluate risk of identified trends, determining causes such as production quality, inadequate labeling, or user error• Conduct bi-annual Management Review Meeting with stakeholders and company executives
Education
Johns Hopkins Whiting School of Engineering
Master of Engineering - MEng
2023 — 2026
Rutgers University
Honors Engineer’s Degree
2016 — 2020
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