Business Process Improvement Analyst / Release 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

Join a dynamic product release and configuration management team supporting the launch and control of labeling, packaging, and finished goods documentation for a highly regulated medical device environment. This role is ideal for someone who thrives on detail, enjoys working across interconnected systems, and can help ensure product data, eManuals, and release processes are accurate, efficient, and compliant.

Responsibilities

• Support product setup activities and change notification workflows within a product lifecycle management system.
• Create, update, and maintain finished goods, models, and related product data to support release activities.
• Assist with electronic manual staging, release, and website updates following established quality and editorial procedures.
• Prepare and route documentation needed for product design control, labeling, and packaging release.
• Review components and related information before release to help confirm requirements are met and reduce rework.
• Perform change control checks, labeling proofs, and print file preparation as part of quality system support.
• Help with unique device identification verification, device master record indexing, and other product release tasks.
• Partner with cross-functional teams to resolve content, quality, and schedule issues.
• Contribute to process improvement efforts, metrics, root cause analysis, and documentation updates.
• Support testing and qualification activities for eManuals tools and related system enhancements when needed.

Skills

• 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, high-quality work.
• Ability to work through complex, connected processes and use sound judgment to solve problems.
• 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 common software tools such as Word, Excel, and Adobe Reader.
• Ability to work independently with general supervision while staying aligned to quality procedures.

Preferred Skills

• Experience in a regulated environment, especially within medical devices.
• Familiarity with FDA, ISO, EN, or GMP standards.
• Exposure to labeling, packaging, product release, or configuration management processes.
• Experience supporting eManuals, PLM systems, or related documentation workflows.
• Ability to adapt quickly to shifting priorities and multiple assignments.
• Experience contributing to process improvement initiatives such as Lean or Six Sigma.
• Interest in collaborating on testing, documentation, and operational improvements.

Horizontal is committed to fostering an inclusive workplace where every person feels respected, valued, and supported. We welcome applicants from all backgrounds and encourage individuals with a wide range of experiences and perspectives to apply.

By applying for this position, you acknowledge and agree that Horizontal Talent may contact you regarding your application using automated technology, including phone calls, SMS/text messages, or email, which may be delivered by our virtual AI recruiter, Alex.