
Midhun Jose
Process Engineer

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Skills
AutocadLean manufacturingMechanical engineeringMicrosoft officePro engineerSix sigma5sPtc creoManufacturing processesVerificationValidationQuality systemMrbSolidworksRoot cause analysisPlcProcess engineeringMicrosoft excelAutomationManufacturing engineeringFdaIso 13485FmeaMedical devicesQuality assuranceQuality managementMinitabAbout me
Auditor with vast experience in electromedical devices domain. Lead auditor for ISO 13485 and 9001. Performing project planning for technical file review and quality management system audit. Assess technical files against European directives. Previously experienced Process Engineer with a demonstrated history of working in the electrical and electronic manufacturing industry. Skilled in AutoCAD, and PTC Creo. Professional with a Degree focused in Mechanical Engineering from Manipal Institute of Technology.
Education

Manipal Institute of Technology
2010 - 2013Degree Mechanical EngineeringActivities and Societies: Robomanipal Mechanical

NTTF
2006 - 2009Diploma Mechatronics, Robotics, and Automation EngineeringDiploma in Mechatronics
Experience

GE HealthCare
Nov 2013 - Apr 2015Process EngineerProcess Engineer for Vascular and MR subsystems

Flex
Apr 2015 - Aug 2017Process EngineerProcess engineer for medical products

Zenith Quality Assessors Pvt. Ltd.
Sept 2017 - Aug 2019QMS Auditor and Product AssessorQMS audit and product certification as per 93/42 EEC for medical devices.

HCLTech
Sept 2019 - May 2023Lead- Regulatory Affairs
Sept 2022 - May 2023Senior Regulatory Affairs Specialist
Sept 2019 - Sept 2022

Siemens Healthineers
May 2023 - nowMedical Device Auditor- SaMD
Licenses & Certifications
- View certificate

Mini-Course MDR 2017/745
Easy Medical DeviceMar 2019 - View certificate

Digital Manufacturing & Design
CourseraMay 2018 - View certificate

Introduction to Bio medical Imaging
The University of QueenslandJun 2018 - View certificate

Working with Difficult People
LinkedInJan 2024
Languages
- hiHindi
- maMalayalam
- taTamil
- enEnglish
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