Summary
Overview
Work History
Education
Skills
Certification
Projects
Publications
Timeline
Generic

Pranjali Tambe

San Diego,United States

Summary

Results-driven quality leader with over 10+ years experience in compliance and risk management for medical devices. Expert in ISO 13485 and FDA regulations, with a proven track record of fostering a strong quality culture and mentoring high-performing teams. Adept at identifying compliant paths forward by collaborating cross-functionally with stakeholders to meet both regulatory requirements and business objectives. Known for driving significant improvements in design control processes, enhancing product readiness, and ensuring compliance across development environments.

Overview

12
12
years of professional experience
1
1
Certification

Work History

Lead Product Quality Engineer

ResMed
San Diego, CA
06.2025 - Current
  • Led compliance and quality initiatives for ResMed’s digital product portfolio, including SaMD and mobile health applications.
  • Collaborated with software engineering and architecture teams to ensure compliance with global standards.
  • Drove formal software design reviews and safety risk analysis processes to address patient risk.
  • Developed design control processes across Agile and DevOps environments, enhancing team understanding of quality requirements.
  • Led design changes for software updates, OTA (over-the-air) activities, and hardware (sensor) products.
  • Drove alignment between product vision and system requirements by partnering with multidisciplinary teams across engineering, clinical, regulatory, and marketing domains to ensure the cohesive development of software-based medical solutions.
  • Develop a QA plan and strategies for digital health and AI/ML products.

Manager - Design Quality Engineering

Illumina
San Diego, California
05.2021 - 06.2025
  • Led design quality engineering for new product development, focusing on Class II and III standards.
  • Directed risk management activities across product portfolio, ensuring completeness of risk management documents.
  • Audited quality and completeness of product design history files for compliance and accuracy.
  • Supported software development and testing, ensuring thorough reviews and tool validation.
  • Devised strategic solutions for project decisions impacting product quality and business success.
  • Coordinated cross-functional teams to meet pharma partner milestones, generating over $50M in value.
  • Drove improvements in employee engagement and developed talent within the design quality team.
  • Managed design verification, validation, transfer processes, and human factors considerations.

Senior Manufacturing Quality Engineer

Illumina
San Diego, California
02.2018 - 05.2021
  • Led product and process risk management activities to ensure quality in project documentation and validation protocols.
  • Established controls and specifications for seamless translation of design requirements to production readiness.
  • Collaborated with cross-functional teams to resolve quality issues, applying nonconformance and CAPA processes.
  • Directed pFMEA activities to document process failure modes and implement effective mitigations.

Product Quality Engineer

Abbott (Alere Inc, St. Jude Medical)
Dallas, Texas
11.2013 - 02.2018
  • Developed and implemented failure investigation processes to determine root causes of product quality issues.
  • Led NC and CAPA processes, ensuring timely closure of action plans.
  • Evaluated process changes for compliance with verification and validation requirements.
  • Provided technical assistance for field inquiries regarding implantable and external products.

Education

Master of Science - Bioengineering

University of Texas At Arlington
Arlington, TX
08.2013

Bachelor of Engineering - Biomedical Engineering

Gujarat University
India
06.2011

Skills

  • Quality Management Systems (ISO 13485)
  • FDA Regulations (21 CFR Part 820)
  • Quality leadership
  • Design Controls and Risk Management (ISO 14971)
  • SaMD, SiMD
  • IEC 62304, IEC 82304
  • Root Cause Analysis and CAPA
  • Software Development Lifecycle (SDLC) process
  • Technical Documentation (DHF, DMR)
  • Confluence, JIRA
  • Excellent communication skills
  • Problem solving and decision-making

Certification

  • Medical Software and Medical AI program, Yale University- June 2025
  • RAPS - Software as Medical Device, 03/01/24, Present
  • AAMI - Design Controls, 09/01/22, Present
  • ASQ-CQE and Six Sigma Yellow Belt

Projects

NightOwl - Home Sleep Apnea Test

Product quality lead for NightOwl product that utilizes sensor to gather sleep data which is autoscored with an algorithm that is clinically validated. Successfully worked on leading strategic decisions with cross functional team to navigate regulatory complexities. 

TruSight Oncology 500 HRD product launch

Key contributor and stakeholder for TruSight Oncology 500 HRD product launch. This project was based on companion diagnostics partnership to develop oncology assay for Next Generation Sequencing powered by DRAGEN analysis SW. Successfully led the project as the lead Design Quality Engineer from concept phase to transfer to sustaining phase of product development process. 

Publications

  • Nanomaterials for Photo-Based Diagnostic and Therapeutic Applications, Theranostics, 3, 3, 152-166, 02/20/13
  • Synthesis and characterization of a novel pH-responsive drug-releasing nanocomposite hydrogel for skin cancer therapy and wound healing, 11/04/21
  • Polymeric nanoparticles as dual-imaging probes for cancer management, 12/16/16

Timeline

Lead Product Quality Engineer

ResMed
06.2025 - Current

Manager - Design Quality Engineering

Illumina
05.2021 - 06.2025

Senior Manufacturing Quality Engineer

Illumina
02.2018 - 05.2021

Product Quality Engineer

Abbott (Alere Inc, St. Jude Medical)
11.2013 - 02.2018

Master of Science - Bioengineering

University of Texas At Arlington

Bachelor of Engineering - Biomedical Engineering

Gujarat University

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