Experience

TÜV Rheinland North America

• United States
• Public Safety
• 400 - 500 Employee

• Senior Project Engineer | Business Stream-Products, Active Medical Device & IVD's

  • Jan 2022 - Present

  • Qualified product specialist to review below codes of active medical device technical file as per European MDR 2017/745. - MDA 0201 Active non-implantable imaging devices utilizing ionizing radiation - MDA 0202 Active non-implantable imaging devices Non-utilizing ionizing radiation - MDA 0203 Active non-implantable devices for monitoring of vital physiological parameters - MDA 0307 Active non-implantable respiratory devices - MDA 0303 Active non-implantable devices utilising hyperthermia/hypothermia • Acting as a lead engineer on complex projects. Participate in setting technical direction; plan, schedule and coordinate detailed phases of a project. • Training other compliance engineers and test technicians. • Project moderate to highly complex equipment, Ensure product meets regulatory design compliance requirements. • Preparing regulatory compliance project quotes and proposals by assisting in defining customer technical requirements and strategies. • Liaise with other global laboratories to ensure consistency and accuracy of methods with proper interpretations. • Documenting test results for corrective actions, report and audits. Analyze test data and determine expected outcome for tests. Identify and report all deviations. • Establishing and maintaining professional relationship with customers. • Performing other duties as assigned. Show less



TÜV Rheinland Asia

• Germany
• Environmental Services
• 400 - 500 Employee

• Senior Project Engineer | Business Stream-Products, Active Medical device & IVD's

  • Jan 2018 - Jan 2022

  • End to end project management, ranging from design of test plan to the final certification of the product.• Provided regulatory engineering design support to Clients for bringing in IEC Compliance and therby reducing non-conformance to medical device.• Globally represented and contributed from IMEA region as a expert committee member of Technical Competence Center: C05-acoustics. • Worked with internal Cross-functional teams to establish a customer delight on new projects and product revisions.• Internally supported as a member of GTEM (Global Test Equipment Management) for developing a tool as part of global harmonization process and to automate activities like Equipment availability and its usage within subsidiaries ,periodical maintenance, calibration and Repair of test and measurement equipment’s.• Consulted and Co-ordinated with TUVR’s GTAC (Global Technology Assessment Center) specifically with the department of medical device testing and certification for implementing and adopting standard operating procedures.• Interacted cross functionally with NCB TUVR-Japan team for issuing CB certificate for various medical devices.• Demonstrated various medical product(s) to be compliant for both U.S. and Canadian markets through a single license mark (cTUVus).• Issued many number of compliance test reports to FDA for successfully completing 510(K)-Premarket submission and approval for medical devices. • Issued compliance test reports for getting medical device CE certification and access to the European market. • Reviewed risk management file of medical device as per ISO 14971 and ensured total quality approach throughout a product’s life cycle.• Reviewed software development and its Risk management process documents of medical device to show compliance with IEC/EN 62304.• Conducted comprehensive usability analysis for submitted medical device and reviewed built up usability engineering document to meet IEC/EN 60601-1-6 compliance requirements. Show less

• Project Engineer | Business Stream-Products, Active Medical device & IVD's

  • Jul 2015 - Dec 2017

  • Prepared appropriate test plans as per the applicable standard requirement in order to obtain CB Certification for various Medical Equipment such as Defibrillators, Diagnostic/Monitoring ECG, patient monitoring system, Baby warmer, Photo therapy Units, ICU ventilators, Radio graphic X-ray system, Ultrasonic medical diagnostic/monitoring equipment, Vital signs monitor-NIBP & Spo2, newborn hearing screening device and Spiro-meter etc.• Tested medical device as per IEC/EN 60601-1, 60601-2-4, 60601-2-27, 60601-2-25, 60601-2-47, 60601-2-49, 60601-2-21, 60601-2-50, 60601-2-37, 60601-2-30, ISO 80601-2-61.• Tested medical device which is intended for the use in home healthcare environment and EMS environment (Emergency Medical Services environment) as per IEC/EN 60601-1-11, 60601-1-12 respectively.• Tested medical device as per IEC/EN 60601-1-8 and supported client to develop alarm system architecture in a medical electrical system. • Tested medical device to meet mechanical ,reliability and environmental requirements as per customer technical specification.• Supported as a product safety-domain expert to various medical device designers and manufacturers for their overall product development. • Played a lead role in NABL Audit for laboratory scope expansion.• Part of CBTL Audits for Laboratory Accreditation Process.Training Programs Underwent • Internal Training on IEC 60601-1, Edition 3.1.• Internal Training on usability Engineering requirements as per IEC/EN 60601-1-6 and IEC 62366. • Internal Training on medical device software life cycle process requirements as per IEC/EN 62304 and 61508. • Advanced Training on General requirements for the competence of testing and calibration laboratories as per ISO/IEC 17025:2017. Show less

• Project Engineer | Business Stream-Products, Active Medical device & IVD's

  • Jan 2015 - Dec 2017

  • Gathered the product requirements by providing high end technical insights and also Supported root cause analysis.• Handled the product pre-compliance, compliance issues and prepared the compliance CB reports.• Conducted incident risk modelling on systems.• Continuous interaction with the clients in their product development process.• Evaluated products against IEC/EN 60950-1,UL 60950-1,IS 13252 including review and analysis of PCB layout diagram, schematics, transformers, and related components and parts.• Involved in evaluating the various categories of household appliances as per IEC/EN 60335-1.Also dealt with the particular product standard by providing highly technical engineering design to the customer for the product to meet the IEC/EN standard requirement.• Handled the projects requiring TUV GS mark (voluntary certification mark for technical equipment in Germany) and prepared detailed technical documentation to meet the requirement of "German Equipment and Product Safety Act".• Proven track record of developing various test jigs for automating verification as per various international standards as well as for measurement and analysis.• Reviewed the Safety design of PCB layout diagram, circuit diagram, transformer specifications etc.• Conducted hazard assessments. • Assured compliance with all aspects of product safety.• Interaction with several clients from overseas for their product market access. Show less

• Junior Engineer | Business Stream-Products, Active Medical device & IVD's

  • Jan 2014 - Dec 2014

  • Delegated to analyze corrective actions and handled customer inquiries.• Analyzed customer safety specifications and product literature.• Provided engineering, testing and certification support for a below category of products.• Product Domains: medical, IVD, IT

• Trainee Engineer | Business Stream-Products, Active Medical device & IVD's

  • May 2013 - Dec 2013

  • Active participation in group and project teamwork.• Identify applicable regulatory,industry compliance standards and codes.• Wide exposure to Test and Measurement equipments.



ARN Systems (P)Ltd

• India
• Consumer Electronics
• 1 - 100 Employee

• Associate Project Engineer | Business Stream-Projects & Operations

  • Jun 2012 - May 2013

  • Custom designed and installed audiophile grade systems in client place. • Measured acoustic pressure for accurate recreation of sound. • Prepared proposals and Finalized tender design, BOM and technical configurations. • Schedule meeting with clients regarding techno-commercial discussion and also participated in the finalization of the projects. • Custom designed and installed audiophile grade systems in client place. • Measured acoustic pressure for accurate recreation of sound. • Prepared proposals and Finalized tender design, BOM and technical configurations. • Schedule meeting with clients regarding techno-commercial discussion and also participated in the finalization of the projects.