Engineering Project Manager, Medical Devices

2 weeks ago

Irvine, United States Planet Pharma Full time

Title: Project Manager

Location: Irvine, CA - 4 days per week on-site, no exceptions

Type: 18-month contract with potential to extend or convert based on performance and business

Pay: $63 /hour ; Benefits Available

Hours: Standard office hours, M-F. Flexible hours on-site


Group Focus: Support the R&D Engineering PMO.


Top required technical skills?

  • 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


Technology/software required?

  • Must be proficient in Excel
  • Windchill or other PLM software experience required
  • MS Projects and Planning is used by this team


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

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