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