Quality Engineer I

Boston ScientificArden Hills, MN
14h

About The Position

Support manufacturing operations by monitoring equipment performance, troubleshooting process issues, and optimizing production workflows. Conduct engineering analysis for yield fallout investigations, process monitoring, manufacturing instruction compliance, and corrective/preventive actions (CAPA). Identify and implement process control systems to support product development, qualification, and ongoing manufacturing. Work with vendors/suppliers to design and procure tooling, fixtures, and equipment. Train and provide technical support to product builders, technicians, and peers. Lead and contribute to Value Improvement (VIP), DMAIC, or other process improvement projects with cross-functional teams. Collect and analyze data using statistical methods for process characterization, Cpk, and scrap reduction goals. Participate in new product development teams, including technology development, material/product testing, preparation of specifications, and process improvements. Coordinate, manage, and document project goals and progress, recommending adjustments as needed. Serve as a quality representative to communicate initiatives, support decisions, and improve awareness of quality practices. Apply systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues. Interact cross-functionally with internal and external customers and act as a consultant for engineering and quality matters. Incorporate business policies and procedures into all task completion, understanding both company and customer needs.

Requirements

  • Minimum of a Bachelor's Degree in Engineering (Mechanical, Chemical, or related discipline)
  • Minimum of less than one year of experience
  • Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, Outlook)
  • Knowledge of basic Quality Systems and good documentation practices
  • Strong analytical and problem-solving skills
  • Effective communication skills and ability to work both independently and in cross-functional teams
  • Familiarity with product/component documentation, inspection, testing, and Manufacturing Execution System (MES)
  • Experience leading cross-functional teams and driving projects to completion
  • Presentation skills for translating manufacturing performance and issues to peers and senior management

Nice To Haves

  • Experience in medical device or highly regulated manufacturing environments
  • Previous machine shop experience preferred
  • Experience using statistical software (Minitab preferred)
  • Demonstrated curiosity and initiative to identify and drive process improvements

Responsibilities

  • Monitor equipment performance
  • Troubleshoot process issues
  • Optimize production workflows
  • Conduct engineering analysis for yield fallout investigations, process monitoring, manufacturing instruction compliance, and corrective/preventive actions (CAPA)
  • Identify and implement process control systems
  • Work with vendors/suppliers to design and procure tooling, fixtures, and equipment
  • Train and provide technical support to product builders, technicians, and peers
  • Lead and contribute to Value Improvement (VIP), DMAIC, or other process improvement projects with cross-functional teams
  • Collect and analyze data using statistical methods for process characterization, Cpk, and scrap reduction goals
  • Participate in new product development teams
  • Coordinate, manage, and document project goals and progress
  • Serve as a quality representative
  • Apply systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues
  • Interact cross-functionally with internal and external customers
  • Incorporate business policies and procedures into all task completion
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