Title: Project Manager
Location: Irvine, CA - 4 days per week on-site, no exceptions
Type: 18-month contract with potential to extend or convert based on performance and business
Pay: $63 /hour ; Benefits Available
Hours: Standard office hours, M-F. Flexible hours on-site
Group Focus: Support the R&D Engineering PMO.
Top required technical skills?
- Must have 5 years + experience working in Medical Device/Pharma field as a project manager
- Must be a certified Scrum Master and proficient adhering to the Agile Methodology
- Experienced with working on physical device development. Candidates with only software experience will be disqualified
Technology/software required?
- Must be proficient in Excel
- Windchill or other PLM software experience required
- MS Projects and Planning is used by this team
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
o Run intensive planning sessions to build the product back log
o 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
o Coordinate and manage preparations for technical reviews, design control phase gate reviews.
o 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
