Project Manager, Medical Devices

1 week ago

Irvine, United States Compunnel Inc. Full time

Top Software Skills:

  • Must be proficient in Excel
  • Windchill or other PLM software experience required
  • MS Projects and Planning


Must haves:

  • 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 considered


Summary:

  • Seeking a Scrum Certified project manager, preferably with experience supporting medical device R&D projects, that is able to plan, direct and coordinate activities with a cross functional engineering team.


Job Responsibilities:

  • Develop a high-level integrated milestone plan for the development of a cardiovascular medical device through the product development process according to clients quality system requirements
  • Utilize a modified Scrum framework to manage to translate the milestone plan into sprints.
  • 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 for each phase
  • 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
  • Coordinate and manage preparations for technical reviews, design control phase gate reviews.
  • Create and manage the Design History Files within the document system.


Skills:

  • Verbal and written communication skills, problem solving skills, attention to detail and interpersonal skills.
  • Basic ability to work independently and manage one’s time.
  • Expertise in usage of MS Office Suite and related project management systems (such as MS Project desktop, MS Project Online, MS Planner)
  • Basic knowledge of production processes, quality control, costs and other techniques for maximizing the effective manufacture and distribution of goods.
  • Basic knowledge of business and management principles involved in strategic planning, resource allocation, and production methods.
  • Experience in facilitating change, including collaboration with management and executive stakeholders
  • Experience within a regulated environment (preferably medical device)
  • Excellent problem-solving, organizational, analytical and critical thinking skills
  • Strong leadership skills and ability to influence change



Education/Experience:

  • Bachelor's degree, preferably in an engineering or science related field
  • PMI or PMP certification preferred. Scrum certification required.
  • 5+ years of hands-on experience managing large to midsize projects and/or programs of increasing complexity required

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