Summary
Overview
Work History
Education
Skills
Awards Recognition
Projects Handled
Personal Information
Disclaimer
Tool Skills
Timeline
Generic
Muneeswaran S

Muneeswaran S

Regulatory and Sustain Engineer
Arappalayam

Summary

Regulatory and Sustain Engineer with over 7.2 years of experience in medical device documentation, remediation, and design control. Proven expertise in MDR gap assessments, technical file remediation, and product development across urological devices. Proficient in managing complete DHF documentation and STED files for Notified Body (NB) submissions. Strong background in cross-functional collaboration, quality assurance, and compliance with EU MDR and ISO standards.

Overview

9
9
years of professional experience
4
4
years of post-secondary education
3
3
Languages

Work History

Regulatory and Sustain Engineer

HCL technologies Limited
12.2017 - Current
  • MDR/MDD Remediation: Data Collection, Gap analysis, planning remediation and Implementing remediation activities for Urological Products.
  • Assisting the regulatory team for the effective implementation of MDR in Medical Devices.
  • Understand the project scope on the existing product graphics or new product development projects from project originator.
  • Identifying the gaps by collecting DHF and verifying all the technical documents.
  • Enhances my skills in writing a protocols and reports for compiling MDR Gaps.
  • Grouping and tracking all the technical documents for evidencing in STED documents for final NB Submissions.
  • Good Knowledge in generating the PMS report for UCC products with respect to Review period and risk classifications of a product.
  • Complete a STED R&D sections for Notified Bodies Submission On Time.
  • Grouping all STED section and publish all section in single file for NB submission.
  • Individually lead the Sustenance Project and completed on time with Quality deliverables.
  • Conduct project management meeting with core team members.
  • Coordinating with customer and associates for SAP & DHF update.

Quality Engineer

Unique Industries
11.2016 - 10.2017
  • Maintaining all the Quality records and Process Documents with respect to company Policies and ISO requirement.
  • Visually Inspect the Product on Daily basis for each lot.
  • Tracking the defects and take corrective action for control the rejections.
  • Conduct Incoming Inspection on the Products before production get Starts.
  • Always strict to Process and Inspect the Manufacturing Process to avoid deviations.
  • Received the best performer award for completing ISO 13485 audit successfully.
  • Recognized for receiving 5 out of 5 in client’s rating for Bardex I.C. Foley Catheters.

Education

Bachelor of Engineering Degree - Mechanical Engineering

K.L.N College of Engineering
01.2011 - 01.2015

HSC - undefined

Ananth Memorial Matric Hr. Sec. School

SSLC - undefined

Ananth Memorial Matric Hr. Sec. School

Skills

  • Medical device testing
  • MDR Gap Assessment
  • MDR Remediation
  • DHF
  • Post Market Surveillance
  • Risk Management
  • Design Control
  • PQA
  • Quality Assurance
  • Project Management
  • Solid-works
  • MASTERCONTROL
  • Creo
  • SAP
  • MPP

Awards Recognition

  • Always strict to Process and Inspect the Manufacturing Process to avoid deviations.
  • Received the best performer award for completing ISO 13485 audit successfully.
  • Recognized for receiving 5 out of 5 in client’s rating for Bardex I.C. Foley Catheters.

Projects Handled

  • Offshore Lead and handling the Administrative and Design change Projects for class II medical devices for US region products., 1 Year, Lead design control Projects, Confirming the Scope and shipping lanes with core team members, Ensure the product codes with Marketing, Project Charter, Change Control Plan for deliverables, DHF Audit and AFC completion
  • Individually Handled MDR Projects for IC Catheters, StatLock and Drainage Bags, STED Documentation for NB submission., 4 Years, 6 months, Gap analysis from all technical documents (BIO, Reg, STER, STAB, DHF, DID, RTM and GSPR), Consolidating all the gaps in GSPR document, Remediating the gaps by creating protocols and testing, DV testing conducted for latest standard ISO 20696
  • PMS Report Documentation, 4 Years, 6 months, Confirming the Review Period and Update the R&D sections with respect to risk classification of medical device.
  • Supported for DHF and TechFile remediation for Blunt Fill and Filter needles for MDR., 6 months

Personal Information

  • Date of Birth: 09/23/93
  • Gender: Male
  • Nationality: Indian

Disclaimer

I declare that all the information above is best of my knowledge and belief. I agree to abide by the rules and regulations of the organization and strive for its improvement with relentless vigor.

Tool Skills

  • Solid-works
  • MASTERCONTROL
  • Creo
  • SAP
  • MPP

Timeline

Regulatory and Sustain Engineer

HCL technologies Limited
12.2017 - Current

Quality Engineer

Unique Industries
11.2016 - 10.2017

Bachelor of Engineering Degree - Mechanical Engineering

K.L.N College of Engineering
01.2011 - 01.2015

HSC - undefined

Ananth Memorial Matric Hr. Sec. School

SSLC - undefined

Ananth Memorial Matric Hr. Sec. School
Muneeswaran SRegulatory and Sustain Engineer