Quality Analyst and regulations engineer.

SHREYAS PATIL

Los Angeles, California 323-***-**** *******@***.*** LinkedIn profile

EDUCATION

University of Southern California

Master of Science in Biomedical Engineering August 2023-Present GPA – 3.4

Thesis: Hodgkin–Huxley-based neuronal model harnessing dual-frequency neuromodulation to block pain via K+ channels without paresthesia, enabling more efficient device designs. MIT School of Bioengineering and Research Sciences B. Tech August 2018-December 2021

GPA – 3.58

PUBLICATIONS

Title: Automated oxygen blender for regulation of oxygen saturation in hypoxia patients' Publication: Springer Book Series, Lecture Notes in Networks and Systems' Title: Assistive foot prosthesis for hemiplegic patients' Publication: Cambridge Scholars Publishing Conference: ICCIS 2021 EXPERIENCE

Abbott (Sylmar, CA)

Quality Analyst, Cardiac rhythm Management May 2024-Present

• Practicing Quality management of remote care and implants for Abbott cardiac devices.

• Risk Assessment for device performance.

• Formulating regulatory decisions and quality investigation assignments for cardiac rhythm management.

• Implementing medical device report submission for diagnostics and cardiac implants. TATA ELxsi

Junior Engineer, Medical device regulations July 2022-July 2023

• Employed Medical regulations engineer for Medtronic USA.

• Specialized in Neuromodulation and Pelvic Health Devices.

• Composed Submissions for Countries Outside the European Union for 3+ devices (in compliance with EU MDR and US FDA). Dr. Khans Creations Lab

Engineering Intern, Medical Device development February 2022-July 2022 Subject Matter: Innovative Laryngeal Instrument

• Developed and tested a novel laryngeal instrument to facilitate laryngeal surgeries.

• Utilized computer aided design- Autodesk Fusion 360 for 3D sculpturing.

• Assembled Initial Fabrication of the designed instrument. MIT School of Bioengineering Sciences and Research Engineering Intern, Biological systems design July 2021-September 2021 Subject Matter: Automated Oxygen Blender

• Engineered and implemented negative feedback control system, self-regulating oxygen blender to maintain oxygen saturation at desired levels.

• Utilized MATLAB and Simulink platforms for circuit design and testing. PROJECTS AND COLLABORATION

Automated Oxygen Blender

Project associate, Biological Systems Engineering July 2021-September 2021

• Conceptualized and researched Circuit design and Development of automated oxygen blender.

• Engineered device prototype.

Assistive Foot prosthesis for Hemiplegic patients

Project associate, Biomechanics June 2020-January 2021

• Devised and Tested Assistive Foot prosthesis for Hemiplegic patients over a period of 4 months.

• Design and Modelling prosthesis for foot drop through computer aided design and additive manufacturing. TECHNICAL PROFICIENCY

Programming Languages: Java, Python and C++.

Design software: Autodesk Fusion 360, MATLAB, Simulink, CAD, NI Multisim and COMSOL. Repository of expertise: Regulatory Affairs (US FDA & EU MDR), Neuromodulation, Prostheses and Orthoses, Biomechanics, Medical device design and development, Prototyping, and Systems and signal processing, Risk assessment, Audits, CAPA, FMEA, ISO 13485 and US FDA (21 CFR Parts 820/803). Languages: English and German(elementary).

SKILLS

• Agile Problem-solving

• Empowering leadership

• Systematic Planning

• Stakeholder Engagement

• Effective Prioritization

• Cross-Functional Synergy

MEMBERSHIPS

Volunteer Experience

ODSER(NGO)

Junior Ambassador

• Lead a team of 15 for Project Sambandh - compassionate companionship and support to residents of elderly care facilities.

• Organized and managed a team of 25 for a DIPG fundraiser- for a child suffering from Diffuse intrinsic pontine glioma.

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