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 a “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 t:slim X2 insulin pump with Control-IQ technology. We’re also 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. Since many of our own team members live with type 1 diabetes, or have a loved one impacted by diabetes, the work is personal, and we are committed to the cause. Learn more at tandemdiabetes.com.

A DAY IN THE LIFE:

• 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.
• Performs other duties as assigned.

YOU’RE AWESOME AT:

1. Knowledge, skills & abilities:

• 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.
• Reliable, flexible, and detail orientated with a high sense of urgency.
• Ability to work independently.
• Ability to travel internationally and domestically, required.
• Ability to work effectively in a team environment.
• Ability to effectively use Microsoft Office suite, SolidWorks, Minitab, and other applicable software.
• 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).

2. Minimum certifications/educational level:

• B.S. degree in Science or Engineering or a related field, or equivalent combination of education and applicable job experience.

3. Minimum 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 transfer of testing methodology to manufacturing.

WHAT’S IN IT FOR YOU?

In addition to innovative technology, we have a culture that fosters the idea that the happiest people are the most productive people. Not only do we hire forward-thinking achievers to join our workforce; we reward, develop, and retain them too. Just one of the many reasons of how we #StayAwesome! To learn more about our culture and benefits please visit