Role: Project Management Manager
Location: Irvine, CA
Duration: 16 -18 Months
Job Description:
Seeking a Scrum Certified project manager, preferably with experience supporting medical device R&D projects.
Location/Flex: Preferred for position to be full time on site in Irvine (a minimum of 4 days onsite with flexible hours).
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. Must be proficient in Excel
- Windchill or other PLM software experience required
- MS Projects and Planning is used by this team
- 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
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).
