Certified Scrum Master (Medical Device/Pharma)
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MUST HAVE SCRUM MASTER CERTIFICATION & Medical Device/Pharma experience
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).
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 company's 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
All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance. For unincorporated Los Angeles county, to the extent our customers require a background check for certain positions, the Company faces a significant risk to its business operations and business reputation unless a review of criminal history is conducted for those specific job positions.