Pratik Lavalekar
Norm Compliance Engineer
Pune
Summary
Accomplished Norm Compliance Engineer with a proven track record at Philips Healthcare, adept in Quality Control and Project Planning. Expertise in technical reporting and root cause analysis, significantly enhancing compliance processes. Achieved accreditation for compliance labs, demonstrating exceptional technical and leadership skills.
Overview
8
8
years of professional experience
4
4
Certifications
Work History
Norm Compliance Engineer
Philips Healthcare
Pune
08.2022 - Current
- Providing support for compliance activities, as follows:
- Product knowledge of Digital X-ray products and its structure for approbation testing.
- Understanding and preparing technical file of fluoroscopy and radiography systems including subsystems technical files
- IEC testing (EMC and safety) both at internal or external lab along with test records and test reports.
- Hands on compliance lab equipment, ownership of equipment for proper maintenance & calibration
- Support lab management team in maintaining 6S in compliance lab
- Testing as per applicable IEC/CSA standards
- Testing of Magnetic Resonance (MR) products
- Involvement for accreditation of compliance lab for CSA & Intertek audit as per ISO 17025 standard
- Qualified Test Engineer in WMTC program conducted by CSA
- Qualified Test Engineer in SATELLITE CTF stage 3 Lab program conducted by Intertek
Test Engineer
TUV India Pvt Ltd
Pune
06.2018 - 08.2022
- Providing service for product certification.
- Deciding the Directive and applicable regulatory harmonized standards for the registered inquiry.
- Carrying out the safety/performance testing, inspections as per the applicable standards.
- Conducting the assessment activity as stated and applicable by the applicable standard.
- EMC Directive: IEC 61000 series standards.
- Medical device Directive: IEC 60601-1 and its collateral standards.
- Low voltage directive: IEC 61010, IEC 60950, IEC 61439, etc.
- Machinery directive: ISO 12100.
- Radio Equipment Directive: ETSI 300 328 series.
- Techno-commercial activities from feasibility to final issue of test report to the client, including communication, follow-up, and query solving.
- Acquiring NABL scope for medical devices.
- Testing of medical devices such as Bed Head Unit, HF surgical unit, IR thermometer, Endoscopy scope, Baby incubator, Light source, SMPS, etc.
Auditor
Techeuropa Inspection and Certification Pvt. Ltd.
Pune
06.2017 - 06.2018
- Providing service for CE mark certification.
- Deciding the Directive and applicable regulatory harmonized standards for the registered inquiry.
- Carrying out the safety/performance testing, inspections as per the decided standards.
- Conducting the assessment/audit activity as stated and applicable by the EU directive.
- Reporting to the Notified Body after successfully completing the assessment/audit and thus issuing the CE certificate for the client.
- Area of Exposure:
- Machine Directive, Low Voltage Directive, Pressure Equipment Directive, Electromagnetic Compatibility etc.
- Providing service for ISO 9001:2015 & ISO 13485:2016 certification
- Conducting the audit activity as per the ISO Quality Management System certification scheme.
- Also assisting in the development of the quality system for the start-up organizations.
Testing Engineer
SWEN KONFORMITY
Pune
04.2017 - 06.2018
- Carrying out the safety testing activity as per the various international standards (BS EN, IEC, ISO, ASTM) and under the ISO/IEC 17025 (NABL) guidelines and reporting the results.
- Area of Exposure:
- IEC/EN 60204, 61010, 60601, 60335, 60950, 61439, 60529, 60068, 60695, 61000, ASTM D3359, ASTM B 117, etc.
Education
Bachelor’s Degree - Electronics And Telecommunications
University of Pune
Pune 08.2011 - 06.2015
Diploma - Electronics And Tele-Communication
Maharashtra State Board of Technical Education
Pune, India 04.2001 -
Skills
Quality Control
Project Planning
Technical reporting
Root Cause Analysis
Compliance testing
Certification
Implementation of ISO 13485 system
Sports
I am a professional cricket player. I am currently playing club and corporate level cricket on weekends.
Timeline
Norm Compliance Engineer
Philips Healthcare
08.2022 - Current
Implementation of ISO 13485 system
05-2020
Risk Assessment of Medical Devices as per ISO 14971 standard
08-2019
Test Engineer
TUV India Pvt Ltd
06.2018 - 08.2022
IOSH ‘Managing Safely’
07-2017
• Certified Level 2 in fire and risk assessment under British safety council
07-2017
Auditor
Techeuropa Inspection and Certification Pvt. Ltd.
06.2017 - 06.2018
Testing Engineer
SWEN KONFORMITY
04.2017 - 06.2018
Bachelor’s Degree - Electronics And Telecommunications
University of Pune
08.2011 - 06.2015
Diploma - Electronics And Tele-Communication
Maharashtra State Board of Technical Education
04.2001 -
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