Lalith Manoj N
Summary
Testing and Validation Engineer with hands-on experience in mobile surgical systems and ultrasound device testing. Skilled in testing safety, electrical performance, functionality, image quality, and system stability. Conducts incoming and final quality inspections to ensure product compliance with standards. Basic understanding of medical device regulations including ISO 13485, IEC 62304, FDA 21 CFR Part 820, and EU MDR. Familiar with Device History Records (DHR) and Device Master Records (DMR). Supports the creation and use of Standard Operating Procedures (SOPs) and Work Instructions (WIs). Understands the outline and purpose of FMEA and related documents like Impact Assessments. Involved in Verification & Validation (V&V) and supports change management activities. Works with cross-functional teams to review product and process changes. Reports non-conformances and supports initial root cause analysis (visual, dimensional, electrical, mechanical).
Overview
15
15
years of professional experience
Work History
Testing Engineer
Philips Electronics India Pvt. Ltd.
10.2018 - Current
- Key Result Areas
- Testing & Quality Inspection:
- Performed incoming and final quality inspections of mobile surgery and ultrasound products to ensure system compliance with standards
- Tested mobile surgery products by recording parameters such as AERB compliance, safety & electrical checks, functional testing, image quality, uniformity, and X-ray performance
- Performed process validation (PV) and executed test methodologies using both software and hardware tools
- Involved in product testing, verification, and process implementation
- Non-Conformance & Root Cause Analysis:
- Reported non-conformances (NCs) on time and completed visual, dimensional, electrical, and mechanical defect analysis for root cause
- Full understanding of the NC process and related work instructions
- Delivered root cause analysis for customer complaints and DEFOA issues
- Provided effective corrective and preventive actions (CAPA) for line-stopper issues
- Ensured on-time closure of non-conformances and corrective actions to meet KPI targets (e.g., QN aging, DEFOA)
- Regulatory & Compliance:
- Followed QMS, ISO 13485, and ISO 9001 standards to ensure compliance with medical device regulations
- Conducted Device History Record (DHR) review activities and ensured alignment with Device Master Record (DMR)
- Performed line process audits to avoid non-conformance during internal and external audits
- Participated in managing audits such as ISO 13485 QMS, Environmental & Safety audits, CSA, and FDA audits
- Worked in SAP MES environments for tracking and documentation
- Quality Improvement & Tools:
- Supported product quality improvement activities to reduce defect rates
- Conducted quality data analysis and provided input for quality review meetings
- Working knowledge of continuous improvement tools, including RCA (Root Cause Analysis) and Kaizen
- Basic knowledge of Agile methodology
- Other Contributions:
- Involved in material management, tracking lead time, cycle time, and takt time
- Represented the company in business meetings and client product demonstrations
Sr. Service engineer & Application specialist
Skanray Dental Technologies Pvt. Ltd.
06.2016 - 10.2018
- Key Result Areas
- Installed & maintained radiology equipment in dental diagnostics, clinics, colleges, and hospitals to the highest standard
- Managed critical installations & repairs and diagnosed equipment faults
- Supported dealer partners with the installation & maintenance of equipment
- Communicated technical information & maintenance advice to customers
- Supported sales team for technical explanation & in closing of leads of dental radiology and in treatment units
- Demonstrated demos to the doctors for RVG, OPG & CBCT
- Created leads for supporting of sales team
Service engineer
Mectron Dental India Pvt. Ltd.
04.2014 - 06.2016
Service Engineer
Air Liquide Medical Systems Pvt. Ltd.
07.2013 - 04.2014
Service Engineer
S.R. Healthcare (Authorized Dealer for G.E)
01.2011 - 07.2013
Education
B.Tech. - EEE
Hitech Engineering College, JNTU University
Hyderabad01.2010
Intermediate (M.P.C) - undefined
Ratna Junior College, Board of Intermediate Education
Hyderabad01.2006
Skills
- Quality Assurance & Control
- Defect Management
- Technical Support
- Incident Management
- QA/UAT Management
- Equipment Inspection/ Audit
- Medical Equipment
- Risk Management
- Process Improvement
- Resource Management
- Project Execution
- SAP
- MS Office
- Power BI
PERSONAL DETAILS
Languages Known: English, Hindi & Telugu
Accomplishments
- Conducting Kaizen events for reducing time & waste
- 2021: Won Star Performer Award for excellent performance
Timeline
Testing Engineer
Philips Electronics India Pvt. Ltd.
10.2018 - Current
Sr. Service engineer & Application specialist
Skanray Dental Technologies Pvt. Ltd.
06.2016 - 10.2018
Service engineer
Mectron Dental India Pvt. Ltd.
04.2014 - 06.2016
Service Engineer
Air Liquide Medical Systems Pvt. Ltd.
07.2013 - 04.2014
Service Engineer
S.R. Healthcare (Authorized Dealer for G.E)
01.2011 - 07.2013
B.Tech. - EEE
Hitech Engineering College, JNTU University
Intermediate (M.P.C) - undefined
Ratna Junior College, Board of Intermediate Education
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