Medical Device Engineering

SHAMAL KADAM

267-***-**** • ************@*****.*** • LinkedIn: shamalkadam

OBJECTIVE Extremely industrious and result oriented person, seeking a job opportunity in Quality Assurance and Regulatory Affairs sector in the medical device industry.

EDUCATION Drexel University Philadelphia, PA 19104

MS in Biomedical Engineering (STEM) June 2018

Focus: Medical Device Development Neuroengineering Recipient of Dean’s Scholarship

University of Mumbai Mumbai, India

BE in Biomedical Engineering May 2014

Graduated with First Class

RELEVANT COURSEWORK Medical Instrumentation

Learned an industry-accepted standard for designing a medical device.

• Identified user and medical need.

• Designed a medical device for the need.

• Implemented design controls and development processes for both designing and documentation. Medical Device Development

Learned the diverse sets of disciplines essential to develop a medical device throughout the product development life cycle, such as safety, and making complex engineering decisions that support development of a safe medical device through an examination of risk management, regulatory processes, human factors, and clinical studies.

• Prepared a 510(k) for a Class-II clinical device under development. Biomedical Ethics and Law

Learned how legal and ethical decisions should be made in biomedical work and research. Learned and analyzed Belmont Report, and Code of Federal Regulations (CFR).

• Performed mock IRB meeting.

LAB WORK EXPERIENCE Sept 2017 - Feb 2018

Worked as a volunteer Research Assistant in the Neural Circuit Engineering Lab Research Guide: Dr. Catherine Von Reyn

Drexel University

• Using a behavioral assay to determine the Drosophila Melanogaster’s response to a visual stimulus, to study their neural circuit

• Collecting, processing, and storing data for the behavioral assay, using MATLAB

• Tethering the Drosophila Melanogaster for behavioral assay experiments, as per protocol

• Performing adult Drosophila Melanogaster brain dissection

• Maintaining documentation

INTERNSHIP Working as a Healthcare Administrator Intern Sept 2017 - May 2018 Compassus – Serving with Heartfelt Compassion

Fort Washington, PA 19034

• Worked on Homecare Homebase software

• Performed Internal Audits

• Performed Quality Assurance and Performance Improvement tasks

• Learned the HIPPA regulations, the role of confidentiality, and Patient Bill of Rights

• Learned ethical standards and practices and how policy affects business

• Became knowledgeable with the working and management of various departments in the office

• Maintaining documentation

• Filling and data entry

TECHNICAL SKILLS

• International and FDA regulations (21 CFR)

• Standards: ISO 14971, ISO 13485, IEC 60601, ISO 9001, etc.

• Institutional Review Board (IRB) protocols

• Medical Device: Design Controls, Hazard and Risk Analysis and Management, Clinical and Non- Clinical Studies, Design Labeling, Human Factors, and Informed Consent.

• Can prepare: 510(k), PMA, IDE, and FMEA

SKILLS

• Highly organized

• Strong attention to detail

• Excellent technical writing skills

• Excellent oral and written communication skills

• Good presentation skills

• Computer: MS Office Suite (excellent), MATLAB (intermediate), OpenVibe BCI (intermediate)

• Multi-lingual: English, Hindi, Marathi, and Gujarati

LINKS Academic Work

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