Manufacturing Engineer

The Manufacturing Engineer - Disposable will be responsible for developing and improving the disposables/consumable products used within the Tablo Hemodialysis System. They will collaborate with internal resources, external suppliers, and Contract Manufacturers to bring new products into production and enhance existing ones. The role involves driving process and product improvement activities, resolving technical issues, providing production support, and ensuring product quality and efficiency. The Manufacturing Engineer will also contribute to product development teams, develop engineering and manufacturing documentation, and validate processes and equipment.

Drive process and product improvement activities to promote product quality, overall manufacturing cost, efficiency and manufacturability using statistical techniques, lean manufacturing tools, Six Sigma, tool & fixture design, and DOE for process and equipment.

Resolve technical issues and provide production support to quickly address production issues in a high-volume low mixed manufacturing environment to ensure product supply is not impacted.

Provides technical leadership and Design for Manufacturability input to product development teams.

Work closely with R&D through development and production release of new products to manufacturing and meeting cost targets.

Responsible for developing engineering and manufacturing documentation.

Responsible for process and equipment validation.

Work with PMO team to adhere with project schedules and deliverables.

• B.S. in Mechanical Engineering or similar technical field
• Minimum of 7 years of experience in the manufacturing/design of medical products, with a strong background in the manufacturing & development of disposable/single use medical devices
• Strong knowledge of FDA quality system regulations, GMP, and ISO 13485 requirements

• Competitive salary and compensation package
• Opportunity to work with cross-functional teams
• Strong knowledge of FDA quality system regulations, GMP, and ISO 13485 requirements
• NPI experience
• Green Belt certified preferred
• Experience with high volume manufacturing assembly processes
• Strong computer skills, including proficiency in Microsoft Office Suites, Visio, Minitab, and Visio
• Privacy protection with Applicant Privacy Notice
• Equal employment opportunity commitment to diversity and inclusion in the workplace