Bus Proc Impvmt Analyst - Exempt

We are seeking a highly motivated individual to join our team in Minneapolis, MN. This role offers the opportunity to work on exciting projects within Neuromodulation and Pelvic Health, with a focus on TDD. If you thrive in a dynamic environment and have a keen eye for detail, this position could be perfect for you.

Key Skills Required

• Attention to Detail: High focus on quality, as data entry and system setup are crucial components of this role. Professionalism and accuracy are essential.
• Critical Thinking and Strategy: Ability to understand and navigate complex, interwoven systems and processes without needing step-by-step instructions.
• Cross-Functional Team Experience: Experience working in a matrixed organization is a must.

Main Responsibilities

• Product Setup and Change Notifications: Support within the PLM system, including product setup, BOM creation, product attributes, and driving change notifications for release.
• eManuals Implementation & Release: Manage specifications, staging, verification, print file preparation, release, and activation per Quality processes.
• Finished Goods Implementation Support: Support Device Master Record index creation and release, UDI data analysis, supplier proofs, legal requests, and material equivalency assessment.

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, preferably within the medical device industry.
• Familiarity with FDA, ISO, EN, and/or GMP standards.
• Strong detail-oriented work skills and ability to adapt to multi-task and shift priorities effectively.
• Proficiency with common software packages such as Word, Excel, and Adobe Reader.
• Ability to master proprietary programs quickly and work independently as well as part of a team.

Responsibilities

• Plan, perform, and implement process improvement initiatives such as Lean or Six Sigma.
• Diagram and evaluate existing processes and develop metrics for process measurement.
• Organize, lead, and facilitate cross-functional project teams.
• Collect data to identify root causes of problems and measure performance against process requirements.
• Provide consultation on re-engineering techniques to improve process performance and product quality.
• Deliver presentations and training courses on measurement, analysis, improvement, and control.

Join us in Minneapolis, MN, and be part of a team that values innovation and quality in every aspect of our work.