Tushar Patil
Site Validation/Quality Lead
Loomis,NE
Summary
- BSME, MSME, ASQ- Certified Quality Engineer & AAMI- Certified QS ISO13485.
- Over 10 years of experience as a quality & manufacturing engineer in medical device industries.
- As a Site validation quality lead, guiding engineers on validation and FDA/ISO regulations
- Led team of 12 engineers in remediation of IQ/ OQ / PQ /TMV for manufacturing ICM, Pacemaker.
- Responsible for new product introduction, assembly process planning, process validation, and provide training on Quality standards.
- Performed 8D/ CAPA/root cause analysis to resolve quality issues & monitored process capability.
- Profound knowledge on manufacturing processes, 21 CFR Part 820, process capability and SPC.
Overview
2
2
Certificates
6
6
years of post-secondary education
11
11
years of professional experience
Work History
Site Validation/ Quality Lead
Becton Dickinson And Company
Holdrege, NE
12.2019 - Current
- Performed internal audits to maintain operating procedure and regulatory standards compliance.
- Review and approve site validation including URS, FAT and SAT on new equipment’s and approve CAPA.
- Created requirements for milestones and monitored completion of tasks for QA team.
- Perform DOE, mold validations press validation and verification study on new and existing molds.
- Completed CAPA on major damage on product & illegible print issue.Performed TMV on pull tester (Chatillon) & leakage tester (Packscan) using surrogate samples.
- Performed data analysis for TMV, PQ using Minitab and used appropriate distribution and transformation tools.
- Process validation performed based on process capability study and sterilization performed on packaging.
- Managed testing initiatives, establishing metrics, standards, methodology and necessary testing precautions and scheduling execution.
- Review and decide strategies on Molding, automated assembly line's process validations and data analysis using Minitab (2 samples-test, GRR, ANNOVA) and corporate statistical tools (Annotate, multimodal).
- Evaluated interactions between associates and customers to assess personnel performance and customer satisfaction.
- Investigated variances, performed root-cause analysis and documented corrective actions to resolve complications.
- Acted as key point of contact for all QA aspects of releases by providing QA services and coordinating QA resources internally and externally.
Lead Quality Engineer
Abbott Laboratories, HCL America
Sylmar, CA
08.2018 - 11.2019
- Performed Test Method Validation (TMV) on DC measurement method for low voltage leads using cGMP.
- Compiled and evaluated data to figure out appropriate limits and variables for process and part specifications.
- Completed OQ and PQ on Laser weld schedules which covered entire energy range on Rofin welder.
- Engineering Test Study conducted on 14 Laser weld schedules, for strengthening energy ranges of Pacer ETR’s.
- Released IMV, PFMEA, MVP/R in Teamcenter.
- Lead activities to balance unparalleled quality with scalable yields.
- Designed and developed automated fixture for Lead insertion/withdrawal TMV using Pro/E software.
- As a team lead, shared knowledge about good practices and solutions on complicated issues between Abbott sites.
- Developed training protocols in alignment with company quality standards and ISO 9000 regulations.
- Built strong rapport with team members, management and clients to facilitate efficiency and productivity.
- Collaborated with on-site directors, operations managers and supervisors on engineering projects.
- Completed CAPA on pacemaker welding issue successfully.
- Performed quality inspections and drafted reports to detail non-conforming material issues.
Manufacturing Engineer
Danaher Corporation, Softsense Solutions
Indianapolis, IN
05.2015 - 08.2018
- Completed process validation (OQ/PQ) for Biomek laboratory equipment (it measures particle size from 40nm to 3mm).
- Created ECO’s to change Bill of Material (BOM), drawings, and validation documents.
- Process development and validation activities (design of experiments, data analysis and documentation like PFMEA, Master Validation Plans, validation protocols and reports) for new product launches to meet project's deliverables.
- Created Process at a Glance (PAAG), work instructions for chassis, Multichannel pod, MC Head & Gripper.
- Reduced cycle time of operation by 33% using fixture & changing line layout in the new product department.
- Managed supplier development efforts by creating statements of work and procedures, proposal preparation, projecting lead times, technical costs and budgets for engineering and parts production.
- Served as technical liaison between customer, manufacturing, quality assurance and vendor and supplier personnel to resolve technical and quality issues.
- Promoted Design for Manufacturability philosophy.
- Applied project management metrics and tools in oversight of engineering and manufacturing projects and program services.
Designer III
SIEMENS, Infotree Solutions
Sacramento, CA
07.2014 - 04.2015
- Designed Electrical Enclosure, end wall insulation & Junction Box for light rail & high-speed locomotives.
- Developed jigs & fixtures, production BOMs, routings, CAD/CAM and CNC machining part processing.
- Designed sheet metal parts, structural weldments, Electro-Mechanical packaging, large and small welded and bolted assemblies, fiberglass and plastic parts in PTC CREO Elements/Pro 5.0 (Surfacing, Cabling).
- Followed Geometrical Dimensioning & Tolerancing (GD&T) as per ASME Y14.5 series.
- Actively listened to customers' requests, confirming full understanding before addressing concerns.
- Obtained approval of concepts by submitting rough drafts to management or to client.
Summer Engineering Intern
Schneider Electric
Clovis, CA
06.2013 - 08.2013
- Created work instructions for fabrication shop, paint shop, machining cell & final assembly shop.
- Completed four 8D analysis to improve product quality & reliability.
- Developed new fixtures for products.
Sr. Manufacturing Engineer
Larsen & Toubro Limited
Ahmednagar, India
07.2010 - 07.2012
- Led teams of designers, buyers, and engineers to develop custom design and procure engineering equipment for coil winding machines that meet customer specifications, schedule, and budget constraints.
- Used problem-solving tools (CAPA, 8D) and statistical analysis to effectively resolve failures during development,.
- Reviewed and resolved Non-Conforming Materials Report (NCMRs) and Calibration Equipment Deviation Report.
- Revised design based on Design for manufacturing (DFM) report & Poka-Yoke also improved after DFM.
- Reviewed products for compliance with Design for Manufacturing (DFM) requirements.
- Managed design and manufacturing teams to build proprietary process equipment within aggressive cost and time constraints.
- Applied mechanical troubleshooting skills to develop effective solutions for quality products.
Assistant Manager
Minda Industries Ltd.
Pune, India
07.2008 - 07.2010
- Production, planning, and control of automobiles requirements.
- Liaison between management & production team.
- Monitored budget vs actual production as well as project expense against planned expense.
- Investigated root cause (CAPA) for high scrap issues and implemented techniques to identify and reduce scrap.
- Analyzed process capability statistics (Cp, Cpk) and revised GD&T to reduce cycle time by 9%.
- Six sigma projects: Modified assembly line fixtures to improve product quality & reduce warranty rejections.
- Developed Automation assembly line for mass production of switches by optimizing cycle time 23% (Time study).
Education
Master of Science - Mechanical Engineering
California State University - Sacramento
California 08.2012 - 12.2014
Bachelor of Engineering - Mechanical Engineering
Vishwakarma Institute Of Technology
Pune, India 08.2004 - 04.2008
Skills
Six Sigma
Certification
Certified Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485:2016
Timeline
Certified Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485:2016
11-2020
Site Validation/ Quality Lead
Becton Dickinson And Company
12.2019 - Current
Certified Quality Engineer, American Society for Quality.
08-2019
Lead Quality Engineer
Abbott Laboratories, HCL America
08.2018 - 11.2019
Manufacturing Engineer
Danaher Corporation, Softsense Solutions
05.2015 - 08.2018
Designer III
SIEMENS, Infotree Solutions
07.2014 - 04.2015
Summer Engineering Intern
Schneider Electric
06.2013 - 08.2013
Master of Science - Mechanical Engineering
California State University - Sacramento
08.2012 - 12.2014
Sr. Manufacturing Engineer
Larsen & Toubro Limited
07.2010 - 07.2012
Assistant Manager
Minda Industries Ltd.
07.2008 - 07.2010
Bachelor of Engineering - Mechanical Engineering
Vishwakarma Institute Of Technology
08.2004 - 04.2008
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