Engineering Medical Device

Kevin Reju Skariah

https://www.linkedin.com/in/kevin-skariah-00475517/ +971********* ************@*****.***

Summary

A Mechanical Engineering graduate looking to expand experience in the engineering field, with an experience working in a medical device company. Worked as a Process Engineer under a remediation project by providing technical assistance to the R&D team which included creating, reviewing and approving Risk Management documents, assisting vendors with process validation and assessing process contact materials according to the new regulations.

Education

Rochester Institute of Technology, Rochester, NY May 2019

Master of Engineering in Mechanical Engineering GPA – 3.94/4.00

College of Engineering Guindy, Anna University, Chennai, India May 2017

Bachelor of Engineering in Mechanical Engineering

Area of interest: Manufacturing, Sustainability, Supply Chain Management, Quality Assurance

Courses: Additive Manufacturing, Multicriteria Decision Analysis, Sustainable Energy in Transportation, Renewable Energy Systems, Powertrain Systems, Advanced Engineering Math.

Skills

Software: AutoCAD, Creo, ANSYS, SolidEdge, MS Office, MATLAB, Lingo, Lotus Notes, Visio, Minitab

Certification: Lean Six Sigma Yellow belt certification, August 2018; LEED Green Associate, June 2019

Professional Experience

1.Process Engineer – Zimmer Biomet (Contract) August 2019 – March 2020

Responsibilities:

Review process documentation and validation per industry guidelines, and according to project task list; specifically, TMVs, SOPs, AFMEAs, DFMEAs, PFMEAs, IOVV, RMR, IFUs and Control Plans

Monitored any deviation, address such to management team for Change Control.

Reviewed Standard Operating Procedures (SOPs) for different functionalities and areas of compliance.

Reviewed Process Validation Protocols from the manufacturers to ensure that the process meets FDA requirements, complies with cGMPs and company policies and procedures.

Ensured the medical device was in compliance with 21 CFR Part 820 and ISO 13485

Created Manufacturing summaries for Class 1, Class 1r and Class 3 medical devices for Technical Documentation to comply with EUMDR (European Union Medical Device Regulation)

Created process flows for each family of medical devices.

Analyzed process contact materials used in medical devices with EUMDR requirements.

Identification of worse case part from each category of medical devices.

Updated drawings with the current CE marking and addition of UDI as part of overall change documentation procedure.

Involved in the remediation of 6 Design History Files, participation in document reviews.

Involved in the creation and reviewing of documents as part of the Supplier Production Part Approval Process(PPAP)

Created Risk Management documents - pFMEA’s for each process/ work center (e.g., cleaning, passivation, milling, etc.), DFMEA, AFMEA, V&V Summary as part of remediation activity.

Worked with different suppliers in order to get necessary information for different EUMDR requirements and helped to answer technical related questions to the vendor.

Created Non-Conformance Analysis Report for medical devices as part of Transfer to Production of the Design File Remediation

Involved in the completion of the Validation Review Checklist – reviewing the IQ,OQ,PQ and identifying any gaps in the process.

2.Teaching Assistant - Rochester Institute of Technology, Rochester, NY August 2018 – May 2019

Worked as a TA for Advanced Engineering Math and Engineering Analysis course by grading papers and helping students with their assignments. Assisted the instructor during class.

3.Sustainability Intern - Rochester Institute of Technology, Rochester, NY May 2018 - June 2018

Participated in the research and development of the use of various microalgae to clean wastewater and possible utilization of algal biomass for energy production.

4.Quality Intern - JBM Auto Systems Private Ltd, Chennai, India May 2016 – June 2016

Worked with the Quality team to analyze the defects in sheet metal operations and improve the process by using Lean principles like 6 sigma, 5S, Kaizen, and Poke - Yoke.

Prepared advanced quality planning documents and participated in quality planning activities such as FMEA’s, Process Flow Diagrams, Control Charts, and Gage R&R and capability studies.

Academic Projects

Project with paper: Prototyping of a crop dryer by using a transpired indirect forced convection solar dryer model.

Powertrain Systems: Designed a gear reduction drive for the output of an electric motor by using AGMA design factors. (Team) Tools Used: KISSsys & KISSsoft.

Modeling and experimenting with a prototype solar fruit dryer. (Team)

Decision Analysis: Created an optimization model to minimize cement production cost with minimum C02 Emissions. Tools Used: Lingo

Renewable Energy Systems: Designed a wind and solar hybrid energy systems for a medium scale industry that has an energy consumption of 1000MWh/yr. (Team)

Additive Manufacturing: Designed and manufactured a musical instrument using additive manufacturing. (Team) Tools Used: Fusion 360

Senior Design Project: Numerical Simulation of Flow and Heat Transfer using CFD in a receiver tube of a compound parabolic concentrator (CPC). (Team) Tools used: ANSYS Fluent

Senior Design Project: Effective Thermal Management of High Power LED Systems by varying the heat sink cross-sectional geometry to increase the heat transfer. (Team)

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