MDR- Project Coordinator (Through April 2025 // Candidate can work on site in Minneapolis, MN, North Haven, CT, or Lafayette, CO):
Candidate must be on site at least one day per week (Wednesday)
Top 3 Skills:
Attention to detail
Program/project management experience
Tech Comm or labeling experience
Primary Responsibilities:
Manage and input metadata for eManuals publishing on Medtronic website.
Cross-functional collaboration to support eManuals activities and accuracy of data
Create best practices and process improvements to eManuals activities.
Education Required:
Prefer a 4-year college degree (or equivalent). Minimum would be HS Diploma/GED.
Medical device experience preferred if no Bachelor's degree.
Years' Experience Required: 2+ years of relevant experience
Description:
Configuration Management:
Coordinates with Product Release and Configuration Assurance to prepare and route Engineering Change Orders and Change Actions (CO/CAs).
Fulfill internal customer requests for electronic versions of labeling.
Review parts prior to CO/CA release to ensure that all requirements for end item components and specifications are met, escalating issues as necessary.
Create and maintain end items in a product lifecycle management (PLM) system.
Quality System:
Coordinate with Product Release and Quality Systems to prepare and route product design documentation.
Perform change control audits of labeling and packaging components.
Perform proofs of labeling components and print vendor labeling.
Ensure personal understanding of all quality policy/system items that are applicable.
Follow all work/quality procedures to ensure quality system compliance and high-quality work.
eManuals Release:
Perform the eManuals Release Administrator (ERA) role by staging and releasing manuals to the eManuals website for the operating unit, including specifying the attributes.
Coordinate activities surrounding the qualification and release of eManuals for product launches.
Participate in user acceptance testing for the eManuals website as needed.
Follow established editorial guidelines for populating the attributes of eManual records on the eManuals website.
Participate in requirements definition and testing for new features on the eManuals website.
Work closely with internal and external partners to assist in troubleshooting problems with content, quality, or schedule and negotiate resolution of issues.