TUSHAR K
MN
Summary
NPI Quality Assurance and Design Assurance Engineer with over 7 years of experience in the medical device industry. Skilled in implementing Design Controls and Risk Management in compliance with ISO 13485 and FDA regulations, leading to enhanced product quality and safety. Proven track record in continuous improvement, utilizing Six Sigma methodologies to reduce total return rates and drive cost savings. Experienced in coordinating cross-functional teams for successful product launches and quality assurance projects. Expertise in risk analysis, process validation, and compliance for both new product development and remediation efforts
Overview
7
7
years of professional experience
1
1
Certification
Work History
SENIOR NPI QUALITY ASSURANCE ENGINEER I
STARKEY LABORATORIES.INC
12.2019 - Current
- Played key role in implementing medical device Design Controls and Risk Management within QMS (Quality Management System) in compliance with ISO 13485 and ISO 14971, catalyzing comprehensive quality and efficiency enhancements
- Collaborated with external vendors to successfully deploy and validate Grand Avenue (Medical Device PLM software), ensuring seamless integration and full functionality within existing systems
- Developed and instituted SOPs, Work Instructions, and templates that significantly enhanced efficiency of QMS improvement initiatives
- Conducted comprehensive Risk Assessments, including Hazard Analysis, Benefit-Risk Analysis, Product Safety References, DFMEA, and UFMEA, to minimize potential risks in compliance with ISO 13485 and Six Sigma principles
- Played pivotal role for PCBA supplier qualification efforts to strengthen dual sourcing strategies, ensuring robust and uninterrupted supply chain
- Analyzed customer complaint trends and implemented quality improvement initiatives using Six Sigma principles, including DMAIC methodology, to drive CAPA efforts, resulting in substantial reduction in Total Returns Rate (TRR)
- Act as subject matter expert in Kaizen and Lean methodologies, offering guidance and support to leadership and teams to ensure alignment with organization's continuous improvement goals
- Provided expert guidance as Quality Assurance Subject Matter Expert (SME) on rebranding projects, which expanded business opportunities with international clients
- Played key role in packaging resize initiative as part of continuous improvement project, achieving annual savings of $3.4 million
- Supported R&D teams with expert guidance on Design Verification & Validation testing, accelerating innovation and product development cycles
- Served as Lead Quality Assurance Engineer on multiple continuous improvement projects, successfully reducing Total Returns Rate
- Led as NPI QA for Hearing Aid chargers, software and mobile application projects for groundbreaking “Genesis AI” Hearing Aid product family
- Coordinated document preparation and front room communication for external audits, ensuring accurate and timely submissions
- Conducted hands-on verification testing for mechanical and electrical components, ensuring integrity and performance of new technologies.
DESIGN ASSURANCE ENGINEER
ABBOTT LABORATORIES
01.2019 - 12.2019
- Research, evaluate and if needed, remediate devices to meet quality system requirements
- Characterize, establish requirements and specifications for devices (including justification and supportive testing)
- Prepare Risk profile for products based on Hazard Analysis, UFMEA, DFMEA and PFMEA
- Use experimental, empirical, and numerical analysis to evaluate designs
- Lead test method and model development/validation
- Write and submit Engineering Change orders
- Maintain detailed documentation throughout all phases of development
- Investigate issues and define root causes in complex systems
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
- Comply with U.S Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments
- Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
- Perform other related duties and responsibilities, on occasion, as assigned.
DESIGN VERIFICATION AND VALIDATION LEAD ENGINEER
COOK MEDICAL
04.2017 - 12.2018
- Lead as Sponsor for DHF Remediation Project ensuring FDA compliance on numerous Catheter, Sheath Introducer and Dilator design projects requiring collaboration within multifunctional team comprised of Product Development, Research, Quality, Regulatory, Manufacturing, and Marketing
- Author project plans, Cleaning Effect Analysis (CEA), DFMEA (Design Failure Mode effect analysis), DRTs (Design Requirements table), DCTT (Design Control Traceability Table), DDP (Design and Development plan), Risk evaluation matrix and summary reports for 510(k) remediation projects
- Prepared sales reports on Business Object to ensure scope of RPNs (Real part number) for project plans and report obsolete part numbers
- Conducted clinical and nonclinical testing on medical devices and systems to verify design concepts and sustaining engineering changes
- Evaluate number of tests to be performed on catheters with respect to risk assessment (PMHA Pre Market Hazard Analysis and TPLC- Total Product Lifecycle)
- Write/approve test protocols, summary reports and data reports for clinical and nonclinical testing
- Investigate design failure and nonconforming parts to make appropriate design changes through design change plan and design change control procedures
- Suggest process changes and modify training schedules of operators to close nonconformance studies
- Evaluate verification testing data in Minitab
- Perform all work in accordance with the requirements of the Quality Management System (QMS & QMSOP, and Engineering Practices)
- Responsible for validation strategies, design verifications, and quality process controls
- Lead four 510(K) projects with three successful FDA clearances in market (Ureteral Dilators, Dilation Catheter Sets, Lawsons Nephrostomy Puncture Wire Set and McLean ring feeding tube).
PROCESS VALIDATION SPECIALIST
XELLIA PHARMACEUTICALS
04.2017 - 12.2018
- Prepared (updated) User Requirement Specifications (URS) and Functional Design Specification for Clean Steam Generator, Water for Injection, Nitrogen, Autoclave, and aseptic filling line
- Write SOPs (Standard Operating Procedures) for automation systems
- Create and execute commissioning, IOQ and performance qualification documents
- Review and update design qualification matrix
- Redline P&IDs (Piping and Instrumentation diagrams) for Autoclave and Lyophilization Conduct Test Method Validation
- Author and capture Measurement System Analysis Studies (Gage R&R)
- Document and maintain PFMEA and Flow Charts Statistical Analysis for check weight system (GWP - ISO 9001:2015) for steady flow and accuracy within time on process
- Review calibration certificates for critical and non-critical instruments
- Assist in closing Action items/Deviations introduced while execution of Commissioning and IOQs for utilities through CAPA and Engineering Change control with quality approval
- Make and sign off summary reports for Commissioning, Installation and Operational Qualifications for clean Utilities, black utilities, and aseptic filling line
- Performing environmental monitoring trend analyses, and reviewing/approving environmental sampling results
- Examine existing processes and suggest improvement.
Education
Master of Science in Mechanical Engineering - Mechanical Engineering
Texas A&M University
05.2016
Skills
- Risk Analysis (DFMEA and PFMEA)
- Statistical Data Analysis
- Lean / Six Sigma
- Six Sigma tools expert
- Kaizen
- Project Management
- Packaging and Labeling
- Design Controls
- Medical Device Risk Management
- Artificial Intelligence in medical devices
- PLM (Product Life Cycle Management)
- Gap analysis Agile PLM
- Jbase
- Business object
- Trackwise
- Minitab
- Bluehill 3
- Automation system (Allen Bradley)
- RSLOGIX5000 (Rockwell automation)
- Solidworks
- CREO
- CATIA-V5
- ANSYS
- FileZilla
- Putty
- Design Controls and Risk Management
- 510(K) Remediation
- DHF Remediation and NPD (New Product Development)
- Design Controls for Class II and III Medical Devices
- CGMP
- GMP
- GDP
- GWP
Certification
- Certified Lean Six Sigma Black Belt by Six Sigma Academy Amsterdam
- Completed Certified Lean Six Sigma Black Training from Udemy by Quality Gurus Inc.
Accomplishments
- Recognized with the "Outstanding Leadership in Healthcare" award at the Health 2.0 Conference in Las Vegas on 19 March 2024, for exceptional leadership qualities and contributions to healthcare.
- Recipient of the Quality Excellence Award, a prestigious accolade under the India’s Achievers Award program, acknowledging remarkable commitment to quality in professional endeavors
- Recognized in “Techbullion” for exceptional contributions to healthcare, particularly in leading product launches for Class II and Class III medical devices as well as drug manufacturing.
- Interviewed by “Techbullion” a highly prestigious press media on “Role of AI in transforming Healthcare Analytics”
- Published Paper Title: Risk Management in Medical Device Industry
- Published Paper Title: Emerging Threats in Cyberspace: Implications for National Security Policy and Healthcare Sector
- Published Paper Title: The Influence of AI: The Revolutionary Effects of Artificial Intelligence in Healthcare Sector
- Published Paper Title: Operational Efficiency and Patient Satisfaction: The Role of Robotics Automation in Healthcare Delivery
- Published Paper Title: Revolutionizing Drug Discovery: Harnessing Machine Learning Algorithms
- Published Paper Title: Leveraging AI for enhanced Quality Assurance in Medical Device Manufacturing
- Published Paper Title: Post-Market Surveillance of Medical Devices Using AI
- Published Paper Title: Survey of Artificial Intelligence for Automated Regulatory Compliance Tracking
- Published Paper Title: Robustness and Reliability Testing in Healthcare Using Artificial Intelligence
- Harnessing Artificial Intelligence in Healthcare Analytics: From Diagnosis to Treatment Optimization
- Scholarly article title: The Critical Role of Design Verification Testing in the Medical Device Industry: Ensuring Safety and Effectiveness
- Scholarly article title: Product Risk Vs Patient Risk in Medical Device
- Contribution in Springer Nature Handbook of Biotechnology, one chapter on “AI Regulations in Medical Devices” under peer review.
Timeline
SENIOR NPI QUALITY ASSURANCE ENGINEER I
STARKEY LABORATORIES.INC
12.2019 - Current
DESIGN ASSURANCE ENGINEER
ABBOTT LABORATORIES
01.2019 - 12.2019
DESIGN VERIFICATION AND VALIDATION LEAD ENGINEER
COOK MEDICAL
04.2017 - 12.2018
PROCESS VALIDATION SPECIALIST
XELLIA PHARMACEUTICALS
04.2017 - 12.2018
Master of Science in Mechanical Engineering - Mechanical Engineering
Texas A&M University
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