Senior Release Analyst - Rice Creek, MN (Onsite/Hybrid)

Medtronic • Fridley, MN

410d • $86,400 - $129,600

About The Position

The Senior Release Analyst at Medtronic plays a crucial role in preparing, processing, and implementing quality systems and product design documentation for Neuromodulation and Pelvic Health Labeling and Packaging components. This position involves coordinating with various teams to ensure compliance with quality standards and facilitate the release of electronic manuals on the Medtronic eManuals websites. The role requires a strong focus on quality assurance, configuration management, and product release processes, contributing to the overall mission of improving healthcare access and equity.

Requirements

• Bachelor's degree with 4+ years of job-related experience, OR Master's degree with 2+ years of job-related experience.
• Strong experience working in a regulated environment.
• Experience in a medical device environment.
• Familiarity with FDA, ISO, EN, and/or GMP standards.
• Detail-oriented work skills.
• Ability to adapt to multi-task and shift priorities effectively.
• Proficiency with common software packages (e.g., Word, Excel, Adobe Reader).
• Ability to work independently and as part of a team.

Nice To Haves

• Experience working with outside suppliers for services such as printing and web development.
• Experience with printing and publishing of technical documentation.
• Proven ability to train and mentor others.
• Excellent interpersonal and verbal communication skills.

Responsibilities

• Prepare, process, and implement quality systems and product design documentation deliverables.
• Coordinate with Product Release and Configuration Assurance to manage Engineering Change Orders and Change Actions.
• Fulfill internal customer requests for electronic versions of labeling.
• Review parts prior to CO/CA release to ensure compliance with requirements.
• Create and maintain end items in a product lifecycle management (PLM) system.
• Coordinate with Product Release and Quality Systems for product design documentation.
• Perform audits of labeling and packaging components.
• Conduct proofs of labeling components and manage print vendor labeling.
• Support training development for tools, processes, and best practices.
• Stage and release manuals to the eManuals website, specifying attributes.
• Lead qualification and release activities for eManuals during product launches.
• Participate in user acceptance testing for the eManuals website.
• Facilitate troubleshooting resolution with internal and external partners.
• Analyze and verify requirements for Unique Device Identification (UDI) registration.
• Coordinate deliverables and activities for product release, including Device Master Record (DMR) indexing.
• Analyze metrics for process measurement and identify improvement opportunities.

Benefits

• Competitive salary and flexible benefits package.
• Wide range of benefits and resources to support employees at every career and life stage.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Miscellaneous Manufacturing
• Education Level: Bachelor's degree
• Number of Employees: 10,001+ employees