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Project Manager
17011 Red Hill Avenue Irvine, CA 92614 US
Job Description
*Depending on 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).
Length of the Assignment: 16-18 months
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
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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