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Ledgent - Irvine, CA

posted about 2 months ago

Full-time - Mid Level
Irvine, CA
Administrative and Support Services

About the position

The Certified Scrum Master will lead and manage projects within the medical device and pharmaceutical sectors, utilizing a modified Scrum framework to ensure successful product development. This role requires a strong background in project management, particularly in regulated environments, and the ability to coordinate cross-functional teams effectively. The position is primarily on-site in Irvine, with flexible hours, and focuses on maintaining stakeholder relationships and meeting design control requirements.

Responsibilities

  • Develop a high-level integrated milestone plan for the program and manage program changes according to the change management plan.
  • Utilize a modified Scrum framework to manage a cardiovascular medical device through the product development process according to quality system requirements.
  • Act as Scrum Master and coordinate with the R&D leader/Product Owner and the cross-functional team to run sprints.
  • Run intensive planning sessions to build the product backlog.
  • Drive Sprint Planning, run stand-up meetings, hold Sprint Reviews, and track metrics.
  • Establish, maintain, and influence program stakeholder relationships, expectations, and communications, both internal and external to the organization.
  • Meet Design Control requirements according to the company's Quality System.
  • Coordinate and manage preparations for technical reviews and design control phase gate reviews.
  • Create and manage the Design History Files within the document system.

Requirements

  • Bachelor's Degree in a related field; Engineering degree preferred.
  • 5+ years of hands-on experience managing large to midsize projects and/or programs of increasing complexity.
  • Scrum Master certification is a must.
  • Experience within a regulated environment, preferably medical device.

Nice-to-haves

  • Proven expertise in usage of MS Office Suite and related project management systems (such as MS Project desktop, MS Project Online, MS Planner).
  • Excellent documentation and communication skills and interpersonal relationship skills.
  • Excellent problem-solving, organizational, analytical, and critical thinking skills.
  • Strong leadership skills and ability to influence change.
  • Experience in facilitating change, including collaboration with management and executive stakeholders.
  • Attention to detail.

Benefits

  • Flexible working hours
  • On-site work environment in Irvine
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