Project Manager (Medical Device) - Intellectt INC

Role: Project Mgmt Mgr

Location: Irvine, CA - 92606

Duration: 16-18 Months

Job Description:

Seeking a Scrum Certified project manager, preferably with experience supporting medical device R&D projects.

Key Responsibilities:

• Develop a high-level integrated milestone plan for the program and manages program change in accordance with the change management plan to control scope, quality, schedule, cost, and contracts
• 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 and the cross functional team to run sprints
• Run intensive planning sessions to build the product back log
• Work with the team and the R&D Leader/Product Owner to drive Sprint Planning, run stand- 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 Edwards Quality System
• Coordinate and manage preparations for technical reviews, design control phase gate reviews.
• Create and manage the Design History Files within the document system.

Education and Experience:

• Bachelor's Degree in in related field, Engineering degree preferred
• 5+ years of hands-on experience managing large to midsize projects and/or programs of increasing complexity required

Additional Skills:

• 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
• Experience within a regulated environment (preferably medical device)
• Attention to detail