Bus Proc Impvmt Analyst - Exempt

Join our dynamic team in Minneapolis, MN, where you will have the opportunity to work in a collaborative and innovative environment. We are seeking a dedicated professional with strong attention to detail and critical thinking skills to support our Neuromodulation and Pelvic Health products, with a focus on TDD.

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 meaningful projects. If you are ready to take on this exciting challenge, apply now!