Chetan D

Project Lead | NPD | Design and Development | V&V | Process Validation | | 21 CFR 820 | EU MDR| ISO 13485 ISO 14971 | Medical Devices|

Experienced Project Lead with 14 years of experience in OEMs and Engineering services, leading 15 engineers.

Providing engineering services to Fortune 500 organizations globally, including Thermofisher scientific, Becton Dickinson, Fisher & Paykel, Carrier, Olympus & Baxter , with customers and vendors in the USA, Europe, and China.

The job involves various tasks such as NPD, EPD, Product Design, design and development, end-to-end product life cycle, verification & Validation, Test Method Vlidation, Design Contril Process, Risk Management, Project planning and execution, Cross Functional Reviews, business development, business proposals, Business Analytics, finance management, budget estimation, proposal submission, manufacturing, sourcing, and human resource development.

Regulatory compliance, 21CFR 820, MDR/MDD

• Quality Systems ISO13485 & ISO 14971
• Quality system methodology like CAPA, FMEA, Statistical analysis & Root Cause Analysis
• GD&T & Manufacturing Process, Calibration Activities, Vendor management, Software Support & Hardware Testing, Executing Protocol, Lab Testing, Conducting Review, IQ, OQ, PQ, & MSA Studies.

Projects deliverables within stipulated time schedule and budget

Expert in Data Visualization, Data Analysis, Data modeling for Business KPI, Finance KPIs, Cost Reduction KPIs

Medical Products- Disposables, Infusion Pumps, Syringes, Hypodermic, Flush, Pharmaceuticals, IV-sets, Catheters solutions, Packaging, Sterilization, Biocompatibility, Diabetic pneumatic assembly, Chamber Management, Lab Management, Kidney Dialyses Machine, Software Testing, Mechanical Testing, Test method validation/transfer.

Medical Laboratory Products – Ultra Low Freezers, Chillers, Refrigerators, Cryotanks.

Home Appliances – Dish washer, Fire & safety.Expert in CAD, Solidworks, Proe creo, Autocad.

Supervising team of 15 engineers, handling multiple clients, and multiple NPD projects, manufacturing of products.

cationEducation

Lords Institute of Engineering & Technology logo

Lords Institute of Engineering & TechnologyLords Institute of Engineering & Technology

Bachelor of Engineering - BE, Mechanical EngineeringBachelor of Engineering - BE, Mechanical EngineeringJun 2006 - May 2010Jun 2006 - May 2010

Grade: AGrade: A

Vidhya Vikas

Vidhya VikasVidhya Vikas

Intermediate, MPCIntermediate, MPCJun 2004 - May 2006Jun 2004 - May 2006

Grade: A