Pawan Jaiswal
Manufacturing & Quality Engineer
Raipur
Summary
Experienced Process Validation and Manufacturing Engineer specializing in medical device manufacturing, quality assurance, and regulatory-compliant documentation. Proficient in process validation (IQ, OQ, PQ, TMV), risk management (FMEA, CAPA), and new product introduction (NPI). Demonstrated track record of producing high-quality technical documentation, driving process improvements, and fostering cross-functional team collaboration. Hands-on experience in catheter systems, packaging, labeling, process development, and sustaining engineering in accordance with ISO 13485, FDA 21 CFR Part 820, GMP, and MDSAP requirements.
Overview
7
7
years of professional experience
4
4
Certifications
2
2
Languages
Work History
Engineer
IZiel Healthcare
Pune
06.2023 - Current
- Created, reviewed, and updated 100+ technical documents including MPI, Routers, Process Maps, Supplier Matrices, IFUs, PDDs, MPMs, BOMs, and DHF deliverables for catheter systems, packaging, and testing processes
- Led process validation activities, authoring Equivalency Plans, TMV Reports, IQ, OQ, PQ, MVP, MVR, and DMR documentation
- Conducted Root Cause Analysis, updated FMEAs, authored Engineering Reports for investigation and regulatory submission
- Designed Master BOMs and consolidated technical information improving document clarity and reducing rework
- Supported product and process improvements through parameter optimization, router consolidation, and troubleshooting
- Collaborated with global teams and clients to align deliverables, address technical gaps, and ensure regulatory compliance
- Trained and mentored team members in technical documentation, validation processes, and client communication
- Drafted system architecture diagrams, FAST diagrams, and conducted research on catheter components and lead-free alternatives
- Supported template transfers, document updates, equipment specifications, and process alignment across projects
- Managed stakeholder coordination for IFU re-drafting, design reviews, and vendor communication ensuring quality and scope clarity
Quality Assurance Engineer
Cyient Limited
Hyderabad
02.2022 - 06.2023
- Medical Devices Process Validation - ISO 13485:2016.
- Having experience in Design of experiment.
- Resolved non-conforming purchase materials and implement CAPA for numerous fail parts.
- Experience in risk management, including PFMEA, FTA and other risk management tools.
- Experienced in process improvement (SPC, MSA, CTQ, CTP, SOP, Process flow, Control Plan).
- Experience of Internal audits and process audits, ensure CAPA compliance to NC's
Manufacturing Engineer
Invivo Diagnostic Imaging/Philips Healthcare
Gainesville
02.2020 - 10.2021
- Develop and maintain work instructions, process control procedures and operating procedures.
- Support the creation, review and approval of Supplier Quality and evaluation plans.
- Implement sample testing to validate sample assembly parts in accordance with current process requirement.
- Create, review and maintain IQ OQ & PQ plan and report for new supplier validation and sample quality validation & testing.
- Support the introduction of new products onto the production floor, ensuring manufacturing readiness.
- Support and lead DEFOA root cause analysis and troubleshooting activities, make improvements to the current process to resolve supplier-related quality or compliance issues, manufacturing process compliance.
- Work closely with product development teams to ensure products are designed for manufacturability, assembly, and test.
- Create and review DCNs, ECR\ECOs and support implementation and phase in of product changes.
- Establish appropriate methods, tools, equipment, etc. required to produce products in keeping with the Quality Management System and related stands (ISO 13485:2003 and GMP).
- Perform other duties as assigned by the Manufacturing Engineering Manager or Operations Director
Quality Engineer
Stryker
Dallas
02.2018 - 02.2020
- Company Overview: Stryker is a leading medical technology company.
- Developed and maintained quality management plans from the prototype phase until production.
- Developed initial control plans and containment plans for assembly processes.
- Resolved complex quality issues during production the build of devices. Managed quality technicians, to visually inspect, and document sub-assembly process quality issues during build process.
- Incorporated lean principles to design layout for warehouse, plant and improve process flow to improve throughput by 10%
- Supported fixture redesign to reduce the scrap by 1.2% per day and improve the throughput by 2.1% per day
- Stryker is a leading medical technology company.
Education
Master of Engineering - Mechanical Engineering
The University of Texas At Arlington
Arlington, TX, USA 04.2001 -
Bachelor of Technology - Mechanical Engineering
Dr. A. P. J. Abdul Kalam Technical University
Lucknow, India 04.2001 -
Skills
AutoCAD
MS Office Suite
Word
Power Point
Excel
Visio
Agile PLM
Solidworks SAP
Minitab
Cross-functional Collaboration
Technical Mentorship
Stakeholder Management
Quantitative and Analytic orientated
Well organized
Team player
undefinedAccomplishments
Successfully delivered validation and technical documentation for global medical device clients
Implemented process improvements and design transfer activities recognized by stakeholders
Developed Master BOMs improving documentation clarity and efficiency
Mentored cross-functional teams, enhancing offshore documentation quality
Recognized for technical accuracy, structured approach, and reliable project execution
Certification
Lead Auditor ISO 13485:2016 & MDSAP Quality Management Systems (DNV India)
Timeline
Lead Auditor ISO 13485:2016 & MDSAP Quality Management Systems (DNV India)
08-2024
Engineer
IZiel Healthcare
06.2023 - Current
Lean Six Sigma Green Belt (MSME India)
10-2022
Quality Assurance Engineer
Cyient Limited
02.2022 - 06.2023
Manufacturing Engineer
Invivo Diagnostic Imaging/Philips Healthcare
02.2020 - 10.2021
EIT Certification – Texas Board of Professional Engineers
08-2019
Graduate Certification in Manufacturing (UT Arlington)
05-2019
Quality Engineer
Stryker
02.2018 - 02.2020
Master of Engineering - Mechanical Engineering
The University of Texas At Arlington
04.2001 -
Bachelor of Technology - Mechanical Engineering
Dr. A. P. J. Abdul Kalam Technical University
04.2001 -
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