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
Software Skills:
Must be proficient in Excel
Windchill or other PLM software experience required
MS Projects and Planning is used by this team
Job Description:
Seeking a Scrum Certified project manager, preferably with experience supporting medical device R&D projects.
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 clients 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)