Shailesh Lokhande
Principal Engineer @Boston Scientific
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WORK HISTORY
Principal Engineer @Boston Scientific
Pune, IN
EDUCATION
Shri G S Institute of Technology & Science
Bachelor of Engineering, Mechanical
SKILLS
ABOUT SHAILESH LOKHANDE
21 years of experience in various functions at Boston Scientific, Stryker Global Technologies centre, Becton Dickinson, Dr Reddys & Ranbaxy laboratoriesQualification- Bachelor of Engineering (BE) Mechanical- Approved Manufacturing chemist for Syringes (By FDA Haryana)- Certified Six Sigma Green belt (BDUniversityy)- Certified Lead Auditor CQI IRCA ISO13485:2016 - Certified IQA auditor ISO 13485:2016 (BSI) & ISO 9001: (DNV)- Qualified Trainer & SME for process validation & Measurement System analysis at Stryker - Qualified Divisional Process Owner and SME for Product Environmental compliance (EU MDR Haz substance, RoHS, REACH & EU packaging directive) at Stryker- Qualified for reprocessing of surgical instruments At Stryker- Qualified Trainer for Risk Management at Stryker ( as per ISO 14971:2007)- Qualified Trainer for Risk Management at Boston Scientific ( as per ISO 14971:2019)- Qualified for ETO sterilization process validation & equipment qualification at BD- Qualified Auditor for ETO sterilization Facility at BD- Trained on EU MDR by TUV - Train the trainer by TUV- ALB -Toastmasters InternationalArea of expertise- New Product Development (NPD), design reviews- Validation and verification testing - Advance operations engineering (DFM & Design transfer)- Manufacturing Engineering, Process development, continuous improvement using lean and six sigma- Process Validation & Measurement System Analysis - Risk management- Quality Management System (ISO ISO13485, ISO 14001 & ISO 14971)- Qualification of the lab and test equipment- Project Management & Facility development - SME Sterilization/reprocessing (ETO per ISO steam ISO 17664, 17665-1 & 2, AAMI ST 79, cleaning TIR 12 & 30, Materials per TIR 17, Biocompatibility per 10993 series)- Design review of new sterilization chamber, utilities, processes and FAT- Software validation and hardware upgrade for ETO sterilizer- Facility construction, DLC room, Blast door, blow-off roof, ventilation and electrical installation- Process hazardous analysis (Hazop study) & Up-gradation of fire protection system(deluge system, sprinkler) as per NFPA & FM Global standards, best engineering, maintenance and safety practices- PMS ( PSUR, Compliant analysis)- NC/CAPA
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