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.