Veracyte, Inc.

Project Manager

Veracyte, Inc.

full-time

Posted on:

Origin:  • 🇺🇸 United States • California

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Salary

💰 $103,000 - $118,000 per year

Job Level

Mid-LevelSenior

Tech Stack

PMP

About the role

  • Lead project management of diagnostic development programs from feasibility through development, verification/validation, regulatory submission, and commercialization
  • Drive cross-functional core teams (R&D, QA/RA, Clinical Affairs, Manufacturing, Supply Chain, Commercial) to achieve program milestones on time, within scope, and on budget
  • Serve as a leader for assigned programs/projects, including leading senior level personnel
  • Develop and maintain integrated project plans, timelines, risk registers, and mitigation strategies aligned with the Product Development Process (PDP)
  • Partner closely with regulatory and quality teams to align project activities with global regulatory pathways (e.g., IVDR, US FDA 510k, PMA) and QMS requirements (e.g., ISO 13485, MDSAP, US FDA 21 CFR 820)
  • Drive the team for creation, review, and approvals of QMS documentation to support stage gate exits
  • Prepare and present project status, risks, and strategic recommendations to governance committees and executive leadership
  • Foster a culture of accountability, collaboration, and continuous improvement across teams and stakeholders
  • Contribute to the development of PMO processes and tools and to the design and implementation of project management framework and tools
  • Identify, raise, and address issues or risks and identify individual project resource requirements and portfolio capacity
  • Report regularly on project status, milestones, and KPIs to senior leadership
  • Work with business leaders and PMO leadership to align product/program roadmaps to goals, portfolio priorities, budgets, and resource plans
  • Other duties as assigned

Requirements

  • Minimum of 5+ years of project management experience within the IVD, diagnostics, or medical device industry
  • Bachelor’s or master’s degree in life sciences, biotechnology, engineering, business, or related field preferred
  • Deep understanding of product development under ISO13485 and lifecycle management
  • Strong working knowledge of IVD design development processes, including clinical validation, regulatory pathways (e.g., CE/IVDR, ISO 13485, 510(k), PMA), and quality systems
  • Proficiency in project management methodologies and tools; Smartsheet knowledge and experience preferred
  • Excellent communication, collaboration, and leadership skills with the ability to influence at all levels of the organization
  • Ability to effectively lead people and drive results through cross-functional engagement/alignment
  • Experience working with cross-functional teams, including Product Development, clinical, regulatory, operations, and commercial departments
  • PMP or equivalent certification preferred
  • Comfortable with ambiguity