SHEFALI GUPTA
Fremont,CA
Summary
Highly skilled Technical Program Manager with 8+ years of experience delivering NPI (New Product Introduction) and Improvement projects across Biotech/ Life Sciences industries using Agile and Scrum methodologies. Adept in team leadership, data driven decision-making, risk mitigation, process optimization, stakeholder engagement and technical project management skills
Overview
7
7
years of professional experience
Work History
Technical Program Manager
Thermo Fisher Scientific
California
06.2021 - 04.2025
- Spearheaded end-to-end program delivery of New Product Introduction (NPI) and sustaining projects. Coordinated efforts of >15 team members globally ensuring alignment with scope, schedule and budget.
- Championed a ‘Cybersecurity SW Update’ initiative using Software Development Lifecycle (SDLC) and ensured compliance with quality (ISO 13485) and FDA regulations on In-Vitro Diagnostic (IVD) instruments.
- Championed digital health platform delivery integrating patient monitoring and data analytics using Project Lifecycle Management (PLM).
- Collaborated cross-functionally including operations, SW, engineering and developed technical roadmaps, Gantt charts, SOPs, budgets and resource plans while facilitating daily-sprint standups using Jira.
- Conducted phase-gate reviews and reported KPIs, ROI, financials (Capex/ Opex), risks and mitigation strategies.
- Maintained Design History File (DHF) records by creating and managing documentation release packages such as DCOs, MCOs, ECR, etc. in Oracle Product Lifecycle Management (OCPLM).
Project Management Analyst (Client - Draeger Medical)
Laksans Technologies
Massachusetts
10.2020 - 06.2021
- Created informative dashboard of Class 2 medical devices and led the process improvement effort for packaging & labeling operations ensuring compliance with MDR regulations.
Associate Program Manager
Candela Medical
Massachusetts
07.2019 - 04.2020
- Steered Verification & Validation (V&V) effort of a new product release and achieved the critical submission of the EU MDR, 2 weeks ahead of schedule by optimizing the process.
- Implemented effective communication plan across Marketing and Sales team, resulting in a 20% reduction in Go-to-Market (GTM) strategy timeline across medical and surgical aesthetics hardware development NPI programs.
Project Coordinator
BD (Becton Dickinson & Company)
Massachusetts
03.2018 - 05.2019
- Developing project status summary report including KPIs, SPI, NPV, ROI and Risks to report to senior stakeholders and tracked key project milestones and gathered weekly progress updates from different cross-functions (QA, QC, V&V, RA, Eng).
Education
Master of Science - Project Management
Northeastern University
Boston, MA12.2017
Bachelor of Arts - Economics
University of Delhi
Delhi, India10.2014
Skills
- Jira
- MS Project
- Smartsheet
- Asana
- SQL
- Confluence
- Power BI
- Tableau
- SharePoint
- SAP
- ERP
- Oracle
- Scope and Budget Planning
- Process Improvement
- Change Management
- Stakeholder Management
- Risk management
- Scope Creep
- Resource management
- Data Analysis and Interpretation
- Vendor Management and Contract Negotiation
- Communication and Presenter Skills
- Decision-Making
- Attention to Detail
- Time management
- Team Player
- Problem Solving and Critical Thinking
- Conflict Resolution and Negotiation
- Software development lifecycle
- Data analytics
- Process improvement
- KPI reporting
- Product lifecycle management
- Cross-functional team leadership
Timeline
Technical Program Manager
Thermo Fisher Scientific
06.2021 - 04.2025
Project Management Analyst (Client - Draeger Medical)
Laksans Technologies
10.2020 - 06.2021
Associate Program Manager
Candela Medical
07.2019 - 04.2020
Project Coordinator
BD (Becton Dickinson & Company)
03.2018 - 05.2019
Master of Science - Project Management
Northeastern University
Bachelor of Arts - Economics
University of Delhi
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