Nisarth V.
Project Engineer @Intellectt Inc
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WORK HISTORY
Project Engineer @Intellectt Inc
Concurrently managing 13 cost improvement alternate vendor qualification GMI projects in class 3 medical device industry.
EDUCATION
College of Engineering and Applied Sciences at Western Michigan University
Master of Science - MS
Gujarat Technological University (GTU)
Bachelor of Engineering - BE
ABOUT NISARTH V.
Project Engineer in the Class medical device industry with experience supporting mechanical design, manufacturing processes, and quality-driven product development in regulated environments. I collaborate closely with R&D, Quality, Regulatory, Manufacturing, and Supply Chain teams to drive projects from concept to commercialization while ensuring compliance with FDA, ISO 13485, and GMP requirements. Organized, proactive, and solution-driven, I thrive in fast-paced settings where timelines, quality, and patient safety are critical.CORE COMPETENCIES:Project & Program Management: Project Planning & Scheduling (Gantt, milestones, deliverables), Cross-functional Leadership & Stakeholder Management, Risk Management & Mitigation PlanningChange Management (ECO/ECN, Change Control)Quality & Regulatory (Medical Devices): Design Controls (DHF, DMR, traceability), CAPA, Root Cause Analysis (5 Whys, Fishbone), Process Validation Support (IQ/OQ/PQ), GMP Compliance, Audit Readiness & Documentation ReviewManufacturing & Mechanical Engineering: Manufacturing Process Support & Continuous Improvement, Lean Manufacturing & Process Optimization, Supplier/Vendor Technical CoordinationTechnical Tools & Software: MS Project, SAP Ariba, SAP GUI, PLM Systems (Windchill & Agile), Minitab, Excel (Dashboards, Pivot Tables), SolidWorks / AutoCAD (Design Support), Visio
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