Medical Device Release & Process Improvement Analyst

Horizontal Talent; Fridley (MN); On-site; USD 60,000 - 90,000; Full time

Job summary

Horizontal Talent seeks a detail-oriented specialist to support labeling, packaging, and finished goods documentation in a regulated medical device environment. You will manage product data, eManuals, and release processes across multiple systems to ensure accuracy and compliance.

Responsibilities include supporting PLM change workflows, preparing release documentation, and coordinating with cross-functional teams to resolve issues, improve processes, and maintain quality standards.

Qualifications

• Bachelor's degree with at least 2 years of relevant experience or a master's degree with 6+ months of relevant experience.
• Strong attention to detail and a commitment to producing accurate work.
• Ability to work through complex, connected processes and use sound judgment.
• Experience collaborating with cross-functional teams in a matrixed environment.
• Comfort working with product data, spreadsheets, documentation, and multiple systems.
• Clear communication skills and the ability to manage priorities effectively.
• Ability to learn new tools and proprietary systems quickly.
• Proficiency with Word, Excel, and Adobe Reader.

Responsibilities

• Support product setup activities and change notification workflows within a PLM system.
• Create, update, and maintain finished goods data to support release activities.
• Assist with electronic manual staging, release, and website updates per quality procedures.
• Prepare and route documentation for design control, labeling, and packaging release.
• Review components and related information before release to confirm requirements.
• Perform change control checks, labeling proofs, and print file prep as part of QA.
• Help with unique device identification verification and device master record indexing.
• Partner with cross-functional teams to resolve content, quality, and schedule issues.
• Contribute to process improvements, metrics, root cause analysis, and updates.
• Support testing and qualification activities for eManuals tools and system enhancements.

Skills

Attention to detail

Cross-functional collaboration

Effective communication

Prioritization

Independent work with supervision

Education

Bachelor's degree + 2+ years relevant experience

Master's degree + 6 months relevant experience

Tools

Word

Excel

Adobe Reader

Job description

Horizontal Talent seeks a detail-oriented specialist to support labeling, packaging, and finished goods documentation in a regulated medical device environment. You will manage product data, eManuals, and release processes across multiple systems to ensure accuracy and compliance.

Responsibilities include supporting PLM change workflows, preparing release documentation, and coordinating with cross-functional teams to resolve issues, improve processes, and maintain quality standards.