Meera Doshi
Carlsbad,CA
Summary
AI and Data Science Leader with expertise in predictive modeling and cross-functional collaboration. Delivered efficiency improvements through AI-driven automation and Neo4j graph database implementation. Demonstrated success in regulatory compliance and technical mentoring, enhancing data-driven decision-making in product development. Saved $24 million+ through data-driven optimization initiatives. Focused on continuous learning and innovation to drive results.
Overview
16
16
years of professional experience
1
1
Certification
Work History
Senior Data Scientist
Boston Scientific
Carlsbad, California
08.2023 - Current
- Led AI and data science initiatives, developing predictive models for device reliability and failure analysis.
- Created an automation tool for hazard analysis, streamlining risk documentation processes and enhancing efficiency.
- Developed an AI tool to detect off-label use of medical devices utilizing machine learning algorithms and NLP techniques.
- Collaborated with R&D, quality, and regulatory teams to strengthen data-driven decision-making in product development.
- Designed and implemented a Neo4j-based graph database, linking field complaints to manufacturing data for predictive insights.
- Analyzed large datasets to identify trends and inform decision-making processes.
Senior Design Assurance Core Team Leader
Boston Scientific
Maple Grove, MN
08.2021 - 08.2023
- Led design control initiatives for drug-coated and POBA catheters, ensuring compliance with FDA, EU MDR, and ISO 13485 regulations.
- Led risk management, design matrix, design verification and validation activities, formative evaluation, and other design-related activities supporting Design Input, and Design Freeze Review.
- Liaised with stakeholders, physicians, and senior management to ensure project goals were met on time.
Senior Reliability & Product Engineer
Medtronic
Mounds View, MN
08.2017 - 07.2021
- Supported research and development of the combination product in the therapy delivery business unit for disposable sensor products.
- Led the design of experiments (DOE), process failure mode and effects analysis (PFMEA) activities.
- Provided technical leadership for new product development to steer strategic plans and future projects effectively.
- As a Reliability Engineer, I led a group of engineers onsite and offshore to work on the EU MDR renewal for cardiac implantable products.
- Maintenance of design integrity through post-market changes, and supporting or resolving quality and reliability issues that arise during production and use.
Process Development Engineer
Boston Scientific
Minnetonka, MN
03.2014 - 08.2017
- Led process validation and equipment qualification for AMS Urology and Pelvic Health products.
- Managed a team of 10 engineers in an FDA remediation project, driving improvements in quality systems and validation protocols.
Field Service Engineer
Health Ware Private Limited
Mumbai, India
01.2010 - 01.2012
- Delivered technical support for installation, troubleshooting, repair, and maintenance of Olympus, Storz, Wolf Endoscopes, Dornier Extra Corporeal Shock Wave Lithotripter (ESWL), and various Urology healthcare devices.
Field Service Engineer
Siemens Healthcare
Mumbai, India
08.2009 - 01.2010
- Executed installation and servicing of ultrasound systems, RF surgical instruments, and non-invasive devices while ensuring regulatory compliance.
Education
Master of Science - Medical Device Innovation
University of Minnesota
Twin Cities01.2019
Bachelor of Engineering - Biomedical & Instrumentation Engineering
Saurashtra University
Gujarat01.2009
Skills
- Predictive modeling
- Generative AI
- Neo4j Graph database
- Python programming
- SQL proficiency
- Minitab analysis
- MATLAB expertise
- SolidWorks design
- DOE methodologies
- Certified Scrum Master
- Agile practices
- Cross-functional collaboration
- Technical mentoring
- FDA regulations
- EU MDR compliance
- ISO 13485
- Product life cycle management
- Machine learning
- Statistical modeling
- Risk management
Certification
• Professional Scrum Master (PSM)
• Six Sigma Green Belt
• Design for Reliability and Manufacturability (DFRM)
• Applied Agentic AI for Organizational Transformation (MIT)
• Six Sigma Green Belt
• Design for Reliability and Manufacturability (DFRM)
• Applied Agentic AI for Organizational Transformation (MIT)
Timeline
Senior Data Scientist
Boston Scientific
08.2023 - Current
Senior Design Assurance Core Team Leader
Boston Scientific
08.2021 - 08.2023
Senior Reliability & Product Engineer
Medtronic
08.2017 - 07.2021
Process Development Engineer
Boston Scientific
03.2014 - 08.2017
Field Service Engineer
Health Ware Private Limited
01.2010 - 01.2012
Field Service Engineer
Siemens Healthcare
08.2009 - 01.2010
Master of Science - Medical Device Innovation
University of Minnesota
Bachelor of Engineering - Biomedical & Instrumentation Engineering
Saurashtra University