Bus Proc Impvmt Analyst - Exempt

Lancesoft; Minneapolis (MN); On-site; USD 70,000 - 90,000; Full time

Job summary

Lancesoft in Minneapolis, MN seeks a detail-focused professional to support product setup and change notification within our PLM system. You will implement eManuals and assist with device master records and CMS releases, coordinating with product release and quality teams to ensure compliance.

The role involves cross-functional collaboration, process improvements, and regular documentation updates in a regulated medical device environment.

Qualifications

• Bachelor's degree with 2 years of related experience or Master's with 6 months of related experience.
• Experience in a regulated environment is a plus.
• Experience with medical device environments is advantageous.

Responsibilities

• Plan, perform, and implement process improvements like Lean or Six Sigma.
• Organize, lead, and facilitate cross-functional project teams.
• Develop metrics for process measurement and identify improvement opportunities.
• Provide consultation on re-engineering techniques to improve process performance and product quality.
• Coordinate with Release and Quality Systems for documentation and CN release.

Skills

Attention to detail

Data entry

System navigation

Cross-functional teamwork

Education

Bachelor's degree

Master's degree

Tools

PLM System

Microsoft Word

Microsoft Excel

Adobe Reader

Job description

Join our dynamic team in Minneapolis, MN, where you will have the opportunity to work in a collaborative and innovative environment.

Key Skills Required

• Strong attention to detail with a high focus on quality, especially in data entry and system setup.
• Ability to understand and navigate complex, interwoven systems and processes.
• Experience working on cross-functional teams in a matrixed organization.

Main Responsibilities

• Product Setup and Change Notifications support within the PLM system.
• eManuals implementation & release per Quality processes.
• Additional Finished Goods Implementation support including Device Master Record index creation and release.

A Day in the Life

• Configuration Management: Coordinate with Product Release and Configuration Assurance to prepare and route Change Notifications, review parts prior to CN release, and create and maintain finished goods in a PLM system.
• Quality System: Coordinate with Product Release and Quality Systems to prepare and route product design documentation, perform change control audits, and ensure compliance with quality systems.
• eManuals Release: Perform the eManuals Release Administrator role, coordinate activities for product launches, and participate in user acceptance testing.
• Product Release: Analyze and verify requirements for UDI registration, support Device Master Record indexing, and contribute to process measurement metrics.

Must Haves

• Bachelor’s degree with 2 years of job-related experience, OR Master’s degree with 6 months of job-related experience.

Nice to Haves

• Experience working in a regulated environment.
• Experience working in a medical device environment.
• Proven ability to adapt to multi-task and shift priorities effectively.
• Demonstrated proficiency with common software packages (e.G., Word, Excel, Adobe Reader).

Responsibilities

• Plan, perform, and implement process improvement initiatives such as Lean or Six Sigma.
• Organize, lead, and facilitate cross-functional project teams.
• Develop metrics for process measurement and identify improvement opportunities.
• Provide consultation on re-engineering techniques to improve process performance and product quality.

We offer a supportive environment where you will have the opportunity to grow your skills and contribute to meaningfully projects.