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Medical Device Engineer

Location:
India
Salary:
120000
Posted:
April 15, 2016

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Resume:

C.M. JAI SHRI

LIG:***, **th Cross Street,

Mogappair Erischeme, EMAIL-ID: acudds@r.postjobfree.com

Chennai-600 037. Mobile No: 984*******

CAREER OBJECTIVE:

To pursue a highly rewarding career, seeking for a job in challenging and healthy work environment where I can utilize my skills and knowledge efficiently for organizational growth.

PROFESSIONAL EXPERIENCE:

DyAnsys India Private Limited, INDIA (A Subsidy of DyAnsys Inc. USA):

Duration: Since August 2015

Designation: Management Representative, Regulatory Affairs Engineer and Design & Development Engineer

JOB RESPONSIBILITIES:

Responsible to to ensure the QMS requirements and current Good manufacturing practices are effectively established and maintained in the organization.

Responsible to create, maintain and renew the agreement and NDA's with our External Notified Bodies, Authorized Representative, Suppliers, Subcontractors.

Responsible for writing, reviewing and approving the Quality manual, Quality System procedures, SOPs, Work Instructions, Validation Protocol, IQ OQ PQ Procedure and reports.

Responsible for implementing the consistency in the Quality System by conducting Management Review meetings and Internal Audits.

Responsible to generate the reports for all the Internal Audits, External Audits from Regulatory agencies and notified body and Management Review meetings.

Responsible for maintaining the CAPA and acting as the CAPA owner.

Responsible for handling Medical Device Vigilance Systems inline with MEDDEV 2.12-1 rev8.

Responsible to handle all the Adverse Event Reporting & Medical Device Reporting to FDA, 3EC and other notified body.

Responsible for the Medical Device Recalls.

Implemented and maintaining the EAN Barcode, UDI and GUDID in the organization.

Responsible to maintain the Document Control and Record Control.

Handling the roles of Document control coordinator.

Responsible to create, revise and maintain the DMR and authorize the DHR for all the products developed and shipped from the organization.

Responsible to maintain and authorize Document Change Note (DCN).

DyAnsys India Private Limited, INDIA (A part of DyAnsys Inc. USA):

Duration: Since July 2014 currently handling the responsibilities

Designation: Design & Development and Regulatory Engineer

JOB RESPONSIBILITIES:

Responsible to do Technical Design Documentation for all the new products that are developed in the company.

Responsible to maintain Design Control, Documentation Control and Design History File.

Responsible to maintain and authorize ECR/ECN.

Responsible to create, revise update and release the BOM as a part of Design and Development.

Responsible to create DMR & DHR of the medical equipment as per requirements of 21 CFR 820.

Ensure proper interface between Manufacturing and Customer support.

Contact with Vigilance system and Manufacturing.

Response to Regulatory agencies.

Ensure proper adherence of Quality Management System

Getting periodic regulatory requirement updates from external agencies.

Ensuring the CE & FDA certification for all products

Maintain a timely process which meets or exceeds requirements Medical Device Reporting (MDR) in accordance with Medical Device European regulations, European Vigilance Reporting and any other worldwide regulatory requirements

Manage the documentation of all complaints (MDR, Vigilance, etc) which require reporting to the various regulatory agencies of jurisdiction where the products are located.

Work with authorized representative, worldwide regulatory agencies on inquiries regarding complaints, device reports and recalls.

Assist the investigators during regulatory agency inspections.

Responsible to monitor and review the Sterilization Validation.

Responsible to submit USFDA -510(K) submissions & FDA Clinical trials.

Experienced in 21 CFR Part 820, 803, 822, 806, 801.

Experienced in handling all the Regulatory Audits from USFDA and CE.

Experienced in handling the FDA Form 483 – Inspectional Observations.

Experienced in label designing of the products inline with compliance and reviewing marketing materials in the regulatory aspects.

Experienced in writing TCF for CE mark Submission.

Have wide knowledge on ISO, ASTM, ISTA, ANSI/AAMI Standards (QMS -ISO 13485, ISO 9001, Electrical Safety-IEC 60601, Risk Management- ISO 14971, Biocompatibility- ISO 10993, Sterilization- ISO 11135, 11138, Software – IEC 62304, Labeling, etc.,) related to Medical Device and Medical Device Directives.

Experienced in FDA Quality System regulations and ISO requirements.

Effectively Handling and consistently improving Quality Management system in the organization.

Performing Testing on all the developing products.

Handling Risk Management and Analysis.

Responsible to authorize and release the Products and all supporting materials from the design and development area.

Handling the Verification and Validation activities of all products.

Experienced in writing Validation reports (IQ, OQ, PQ) for Production equipments and Critical process like Sterilization.

Have experience in working with other functions (Quality assurance, Procurement etc)

PROJECTS UNDERGONE:

1. CE marking for the following device.

Active medical Device:

Class IIa: ANSiStim/ AuriStim a TENS equipment (Transcutaneous Electrical Nerve Stimulator) – Type B.

2. FDA Traditional 510(K) and Special 510(K) for Class II device – ANSiStim, a TENS equipment (Transcutaneous Electrical Nerve Stimulator) – Type B.

3. Regulatory Submission to UNITED ARAB EMIRATES, MINISTRY OF HEALTH, MEDICAL PRACTICE AND LICENSE, REGISTRATION & DRUG CONTROL DEPARTMENT

4. Implemented Good Manufacturing Practices (GMP) in the organization.

5. Currently working on De novo (Class III) Submission of Autonomic Nervous System (ANS) monitoring.

6. Currently working on Canadian Medical Device Regulation (CMDR) for Class II (Active Medical Device) and Class II (Cardiology) products.

SKILLS:

Software : Excellent Proficient in Adobe Acrobat XI Pro, MS Office, MS Project

Languages : C, JAVA, SQL, XML

Operating System : Windows XP, 7, 8, Linux-Ubundu, MAC.

ACADEMIC QUALIFICATION:

Perusing Post Graduate Diploma in Medical Device Management in the Institute of Good Manufacturing Practices INDIA.

Under graduation in B.E- Biomedical Engineering with CGPA 7.60 of 10 from

VelTech MultiTech Dr. Rangarajan Dr. Sakunthakla Engineering College, Anna University, Chennai (April’2014).

Higher Secondary Certificate (HSC) with an aggregate of 89.9% from Velammal Matriculation Higher Secondary School, Chennai (2010).

Secondary School Leaving Certificate (SSLC) with an aggregate of 86.2% from PMR Matriculation Higher Secondary School, Chennai (2008).

ACADEMIC PROJECT UNDERTAKEN:

Electronic Stethoscope (6th Semester)

Brain Computer Interface For Activating The Lower Limbs Of Paralyzed Patients (Main Project)

AREA OF INTEREST:

Regulatory Compliance

cGMP

QMS Audits

Circulatory and Orthopedics regulatory submissions

ADDITIONAL QUALIFICATION:

Participated in “Course On Introduction To ‘C’ Programming” at Ramanujan Computer Center, Anna University, Chennai(2010).

Certified in Business English Certificate(BEC) in the University of Cambridge ESOL Examination.

Certified in Robotics(The Thomas Edison Certificate) in the TECHNOPHILIA SYSTEMS PVT. LTD – iCarnegie Powered by CARNEGIE MELLON.

INTERNSHIPS:

Undergone the Internship at “LifeLine Multi Speciality Hospital”, Perungudi, Chennai(2011).

Undergone another Internship at “Chennai Meenakshi Multi Speciality Hospital”, Mylapore, Chennai(2013)

ACHIVEMENTS:

Published a paper “Current Trends In Nanomedicine” in the National Conference on “BIOMED REVOLUTION’12” by BEATS at “Udaya school of Engineering, Nagercoil”.

Published a paper “High Voltage Apparatus And Their Insulations” in the National Conference ETIPS’12 at “VelTech MultiTech Dr.Rangarajan Dr.Sakunthala Engineering College”.

Published a paper “Brain Computer Interface For Paralyzed Patient” in the Second National Conference NTBCOM’13 at “VelTech MultiTech Dr.Rangarajan Dr.Sakunthala Engineering College”.

Participated in the 4th International Project Competition & Exhibition “VISAI 2014” project titled “Brain Computer Interface For Movement Of Paralyzed Lower Limb” held at “VelTech Technical University”.

PERSONAL DETAILS:

Full Name :C.M.Jai Shri

Gender :Female

Father’s Name :Mr. C. S. Meghanathan

Mother’s Name :Mrs. K. Thenmozhi

Date of Birth :25th September 1993

Nationality :Indian

Linguistic Abilities :English & Tamil.

Marital status :Single

DECLARATION:

I hereby declare that all the information given above is correct and true to the best of my knowledge and belief.

PLACE: Chennai.

DATE : 03/10/2016 Yours faithfully,

[C.M. JAISHRI]



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