Manufacturing Engineer I

GROW WITH US:
Tandem Diabetes Care creates new possibilities for people living with diabetes, their loved ones, and their healthcare providers through a positively different experience. We'd love for you to team up with us to "innovate every day," put "people first," and take the "no-shortcuts" approach that has propelled us to become a leader in the diabetes technology industry.

STAY AWESOME:
Tandem Diabetes Care is proud to manufacture and sell the Tandem Mobi system and t:slim X2 insulin pump with Control-IQ+ technology — an advanced predictive algorithm that automates insulin delivery. But we're so much more than that. Our company's human-centered approach to design, development, and support delivers innovative products and services for people who use insulin. Because many of our own team members live with diabetes, or have a loved one impacted by diabetes, the work is personal, and we are committed to the cause. Learn more at

A DAY IN THE LIFE:

This individual applies science and engineering disciplines, methods, and knowledge to the manufacture of infusion sets and related technologies. Key areas of focus include line support; cost reduction initiatives; process development, improvement, optimization, and qualification to assure conformance to established standards and specifications.

WHAT YOU'LL NEED:

• Creates, manages, and releases change orders.
• Develops and updates work instructions, work orders, BOM's, quality specifications, and test methods.
• Troubleshoots production equipment, programs, and processes.
• Tooling and Fixturing design, fabrication, and implementation.
• Participates in continual process improvement activities through Kaizen events, Lean Manufacturing, and Six Sigma designed to optimize process efficiency, reduce costs and lead-times.
• Supports R&D and Design Engineering to aid in the transition of new products and processes to manufacturing:
• Helps develop production test plans, requirements, and specifications.
• Assists Operations, Manufacturing, and Production leaders in Prototype Development Planning activities and pilot build activities.
• Working with the Quality and R&D groups, participates in root cause through failure investigations, and develops and implements corrective and preventive actions, as required.
• Tools include PFMECA, FMECA, DOE, Fish bone diagram.
• Ensures compliance with company policies, including Privacy/HIPAA, and other legal and regulatory requirements.

WHEN & WHERE YOU'LL WORK:

Hybrid: This role will be a mix of in-office work at our Irvine, CA office and remote work. This position is expected to be in office 2-3 days per week but may vary depending on business demands.

EXTRA AWESOME:

• Ability to maintain and enforce Good Documentation Practices (GDP).
• Knowledge and application of principles outlined in Good Manufacturing Processes (GMP).
• Familiar with product specifications, test specifications, process specifications.
• Excellent skills in the following areas: verbal and written communication, interpersonal relationships, organization, time-management, and prioritizing workload.
• Ability to multi-task and problem-solve in a fast-paced, dynamic environment.
• Ability to thoroughly investigate and troubleshoot problems, identify root cause(s), document findings, and implement appropriate corrective actions.
• Capable of managing multiple priorities effectively and ability to research and recommend best course of action from several alternatives.
• Ability to identify opportunities and techniques to streamline existing processes.
• Understanding of mechanical drawings & specifications including geometric dimensioning and tolerances (GD&T).
• B.S. degree in Science or Engineering or a related field, or equivalent combination of education and applicable job experience.
• 1 plus years' experience in medical device manufacturing.
• Experience in an FDA/GMP/ISO environment.
• Lean Manufacturing and 6 sigma experience.
• Experience in process design, development, test, and validation.
• Some integration experience in a manufacturing environment, to assist with the