Overview
Work History
Education
Skills
Industry Standards and Tools
Timeline
Generic

Kriti Srivastava

San Jose,CA

Overview

6
6
years of professional experience

Work History

Operations Project Manager III

Procept Biorobotics
11.2022 - 04.2024
  • Led operations and product development projects, adhering to FDA 21 CFR Part 820 and ISO 13485 standards, utilizing PM tools like JIRA and Smartsheet.
  • Facilitated cross-functional communication between internal stakeholders and external vendors, ensuring project alignment and risk mitigation.
  • Developed and executed product launch strategies, collaborating with supply chain and procurement to manage inventory and demand effectively.
  • Formalized company operating procedures, establishing project governance within operations team, including PMO best practices and design transfer plans.
  • Led root cause investigations and CAPA closures to ensure quality compliance and continuous improvement.
  • Implemented cost-saving measures, optimizing budgets without compromising on quality or performance.
  • Negotiated contracts with vendors and suppliers, securing favorable terms that positively impacted project budgets and timelines.
  • Organized regular stakeholder meetings to provide status updates and solicit feedback on ongoing projects actively managed by the team.

Project Manager II

Cepheid
08.2020 - 11.2022
  • Drove operations process and quality improvement projects, resulting in annual savings of approximately $600k through critical path method and value stream mapping.
  • Increased on-time delivery (OTD) to 95% for engineering projects by implementing project toll gate processes and resource management techniques.
  • Presented project progress, issues, and solutions to upper management and key stakeholders, ensuring transparency and alignment.
  • Streamlined project processes by implementing Agile methodologies, resulting in increased efficiency and reduced costs.
  • Established effective communication among team members for enhanced collaboration and successful project completion.
  • Developed comprehensive project plans with clear timelines, milestones, and budget requirements, ensuring timely delivery of high-quality results.
  • Managed risk assessments and implemented mitigation strategies to minimize potential issues during project execution.
  • Coordinated cross-functional teams and resolved conflicts, maintaining a positive work environment throughout the project lifecycle.
  • Mentored junior team members in project management best practices to enhance their skills and contribute to better overall performance.
  • Prepared detailed reports on project status for stakeholders, ensuring transparency and alignment with objectives.
  • Negotiated contracts with vendors and suppliers, securing quality materials at competitive prices for efficient use of resources.

Clinical Application Engineer

Intuitive
01.2020 - 08.2020
  • Provided clinical product and technical assistance to physicians using Intuitive's Ion endoluminal system during lung biopsy procedures, facilitating early diagnosis and treatment of lung cancer.
  • Identified user concerns and provided feedback for product improvement to training and Clinical Development partners.

Project Coordinator

Intuitive
04.2019 - 01.2020
  • Managed project lifecycles, focusing on engineering software development, labeling changes, and market expansion initiatives in compliance with FDA regulations and ISO standards.
  • Utilized JIRA and Confluence to track project issues and maintain status reports, facilitating efficient project management and communication among stakeholders.

Medical Affairs Intern

BD Biosciences
11.2018 - 04.2019
  • Analyzed the clinical performance of BD IVD reagents and developed scientific validity reports for BD's existing IVD products to satisfy its compliance requirements with EU MDR 2017/746.
  • Assisted clinical scientists in executing clinical workflows, completion of case report forms (CRFs) with a strong understanding of GCP, 21 CFR and FDA regulations.

Systems Verification Intern

BD Biosciences
06.2018 - 08.2018
  • Developed and debugged MATLAB scripts to automate quality control processes, resulting in a 22% increase in efficiency and approximately $100k cost savings per year.

Education

MBA -

University of Massachusetts At Amherst
Amherst, MA
12.2025

BS Biomedical Engineering and Minor in Computer Science -

San Jose State University
San Jose, CA
12.2018

Skills

  • Logistics Management
  • Operational Efficiency
  • Portfolio management
  • Scheduling and Planning
  • Root Cause Analysis
  • Vendor Sourcing
  • Schedule Management
  • Project Management
  • Risk Management
  • Customer Relationship Management
  • Stakeholder Management
  • Data Analysis
  • Project planning and development
  • Budgeting knowledge

Industry Standards and Tools

 Industry Standards: 

  • Design Controls per FDA 21 CFR Part 820 and ISO13485
  • SDLC Methodology per IEC 62304
  • Good Clinical Practices (GCP)
  • Risk management per ISO 14971


Tools: 

  • MS Office
  • Google Suite
  • Planview
  • Tableau Basics
  • Sharepoint
  • Smartsheet
  • Sharepoint
  • JIRA
  • Confluence
  • Ironclad
  • Miro

Timeline

Operations Project Manager III

Procept Biorobotics
11.2022 - 04.2024

Project Manager II

Cepheid
08.2020 - 11.2022

Clinical Application Engineer

Intuitive
01.2020 - 08.2020

Project Coordinator

Intuitive
04.2019 - 01.2020

Medical Affairs Intern

BD Biosciences
11.2018 - 04.2019

Systems Verification Intern

BD Biosciences
06.2018 - 08.2018

MBA -

University of Massachusetts At Amherst

BS Biomedical Engineering and Minor in Computer Science -

San Jose State University

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Kriti Srivastava