JOB DESCRIPTION

The Manufacturing Product Industrialization Engineer is responsible for implementing tailored process development activities for mid complexity projects, integrating design for lean manufacturing into product development lifecycle management, executing complex processes and adhering to safety, regulatory, and environmental requirements, working under limited supervision.

• Work with Project Management Organization and Product Industrialization team members to define project requirements and develop and document project/sub-project plans including deliverables, target dates, schedule milestones, and resource requirements. Work with PIE Manager and Team members to assign and commit appropriate resources to complete tasks
• Organize, integrate, and manage team to complete projects/subprojects adhering to committed project plan. Communicate project status to internal customers and stakeholders.
• Break down part and product requirements into production process, equipment and tool requirements. Work with cross functional team and external equipment manufacturers / tool fabricators to develop and implement production process solutions for complex product designs. Validate and release processes, tools and equipment in medical product Quality Management System.
• Work with internal and external/ supplier resources to develop and implement processes that achieve optimal levels of quality, delivery and efficiency. Apply appropriate tools (ex Lean and Six Sigma) early in development process to drive process development and improvement activities with internal to achieve project and business objectives, cost, quality and efficiency.
• Develop and release of BOM and Product structures in a medical product Quality Management System Device Master Record. Work with internal and external resources/suppliers to Initiate and drive product and process changes within a medical device quality management system.