Nikhil Ravi
Summary
Proficient and results-driven Manufacturing Engineer with expertise in optimizing production processes, ensuring regulatory compliance, and leading critical design and process improvements. Certified in Six Sigma Yellow Belt – Medtronic certified (proficient in 8D Fishbone techniques, PDCA, Five Whys, 5S, DFSS, DMAIC and Lean manufacturing tools (JIT, Kanban, Poka-Yoke, Gemba walks) for continuous improvement with focus on assembly application practices, quality, and scrap reduction with background in Design & Analysis. Proven ability to initiate and sustain quality initiatives (PFMEA, DFMA, DFSS) and effectively manage new product development from concept to launch. Well-versed in applying the manufacturing quality toolset, including DFMEA, Gage R&R / MSA, GD&T, process verification/validation plans, and validation protocol development. Knowledge of new product development: Design Controls, Quality Planning, compliance including DHF, Verification and Validation, Risk Management, Process Validation (IQ/OQ/PQ) protocols and reports.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Senior Manufacturing Engineer
Medtronic
06.2024 - Current
- Tackled and sustained critical design changes and process modifications, based on internal feedback, ensuring strict adherence to organizational objectives, requirements, and quality guidelines.
- Implemented 5 Why's and Fishbone diagram to perform root cause analysis, new work instructions, spreadsheets by working in tandem with the team and releasing Bill of Material (BOM).
- Project Team member for remediation of supplier Process FMEA (PFMEA) and company internal Production Risk Management (PRM) to ensure compliance with FDA QSR 21 CFR 820, ISO 13485, and ISO 14971.
- Managed and coordinated formal process validations and qualifications, which included the thorough development and execution of protocols, ensuring robust and compliant manufacturing readiness.
- Led manufacturing equipment design, fabrication, and/or procurement, and installation, thus significantly enhancing production capabilities by 7%.
- Led a team of Manufacturing Engineers (ME), Quality Engineers (QE), and other teams to reduce scrap, better inventory management, and increase floor stock by 5%, thus increasing profitability by employing Lean principles, SIPOC, and CTQ analysis.
- Responsible for authoring, performing, and/or approving qualification and validation documentation such as Non-Conformance Reporting (NCR), GAP Analyses, and CAPA.
- Used statistical tools such as Design of Experiments (DOE), Process Capability, Measurement System Analysis, and Statistical Process Control to assess and improve production processes.
- Maintained rigorous adherence to product specifications, quality, and regulatory procedures, with organizational standards, consistently ensuring compliance and high-quality, along with high-quantity deliverables.
Manufacturing Quality Engineer
Medtronic
01.2022 - 05.2024
- Prepared and participated in product engineering presentations to stakeholders, vendors, customers, and other departments as required.
- Effectively implemented 5S+1(6S) in the production area to meet safe, productive, and calibrate devices for quality, also implemented process improvement initiatives to emphasize visual control, efficiency, and production planning.
- Conducted in-depth classification of manufacturing processes, utilizing Design of Experiments (DOE) for effective sampling, data collection, and analysis for improved efficiency and quality.
- Participated in writing validation protocols and reports with the team performing Risk Assessment, FMEA to identify root causes of problems, and present possible solutions.
- Ensured current and prospective manufacturing processes met defined capabilities by leading initiatives in Process Failure Mode and Effects Analysis (PFMEA), Design for Manufacturability and Assembly (DFMA), and Design for Six Sigma (DFSS).
- Participated in the flow acceleration project, for optimizing the flow of products to improve efficiency, reduce scrap, by focusing on WIP, bottlenecks, and thus help in delivering finished products to consumers faster.
- Created, owned, and processed Change orders (Product and Record Change Orders).
- Executed Measurement System Analysis (MSA) and Test Method Validation (TMV).
- Acted as a liaison between the engineering team and training operators for validation execution and process updates.
Process Engineer
Johnson & Johnson
10.2019 - 12.2021
- Supported multiple manufacturing lines, providing technical expertise on mechanisms, troubleshooting instruments, and designing fixtures and thus improving manufacturing processes as part of the sustaining engineering.
- Worked effectively in cross functional teams and coordinated with other departments to establish process for workflow.
- Provided technical guide for new product process development, effectively collaborating with manufacturing partners and cross-functional teams to transition designs into scalable production.
- Performed risk assessment for both design and manufacturing processes according to ISO 14971.
- Used SolidWorks as the main CAD modelling and drawing documentation platform and assisted R&D in design transfer to production (NPI) and support for DFM.
- Efficiently and safely designed the parts, products to meet industry standards, including DOT and NFPA.
- Wrote/reviewed technical documents and reports such as protocols, SOPs, filing documentation, and other cGMP documents related to process validation.
- Creation of Data analysis, Technical Reports for waste reduction and increasing the efficiency of the production.
- Generate documentation needed for the program, development activities, and (TMV) validation/verification testing activities.
Education
Master's Degree - Mechanical Engineering
Florida Institute of Technology
Melbourne, FL12.2019
Bachelor's Degree - Mechanical Engineering
National Institute of Engineering
06.2014
Skills
- Root cause Analysis, Six Sigma Methodologies, IQ/OQ/PQ, Lean Manufacturing/Kaizen, TMV (Gage R&R studies), 5S, 5Whys, 8D’s, Kanban, Poka-Yoke, Gemba
- Software/Tools: Solid Works, AutoCAD, ANSYS
- Programming, Mathematical tools & others: Agile PLM, SAP, MATLAB, Minitab, MS Office (Excel, Word, PowerPoint, Access)
- Process Improvement: Design of Experiments (DOE), PFMEA, DFMA, Design for Six Sigma (DFSS), Process Validation, Root Cause Analysis, Statistical Process Control (SPC)
- Manufacturing Operations: Equipment Installation, Production Launch, Process Characterization, Quality Management Systems (QMS), Regulatory Compliance (eg, FDA, ISO)
- Technical Leadership: Project Management, Cross-functional Collaboration, Mentoring, Stakeholder Management
Certification
Certified in Six Sigma Yellow belt – Medtronic certified.
Timeline
Senior Manufacturing Engineer
Medtronic
06.2024 - Current
Manufacturing Quality Engineer
Medtronic
01.2022 - 05.2024
Process Engineer
Johnson & Johnson
10.2019 - 12.2021
Bachelor's Degree - Mechanical Engineering
National Institute of Engineering
Master's Degree - Mechanical Engineering
Florida Institute of Technology
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