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 tandemdiabetes.com

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 transfer of testing methodology to manufacturing.

COMPENSATION & BENEFITS:

The starting base pay range for this position is $72,820 to $91,080 annually. Base pay will vary based on job-related knowledge, skills, experience and may also fluctuate depending on candidate's location and the overall job market. In addition to base pay, Tandem offers a competitive compensation package that includes bonus and a robust benefits package.

WHY YOU'LL LOVE WORKING HERE:
At Tandem, we believe joy fuels excellence. That's why we've built a workplace that celebrates your achievements and supports your well-being. Our team thrives on pushing boundaries and fostering growth, all while maintaining a spirit of fun and camaraderie. This is just one of the ways we stay awesome! Explore the benefits and reasons to love Tandem at https://www.tandemdiabetes.com/careers.

BE YOU, WITH US!

We embrace the value that every single one of us brings to the table. But sometimes we forget that when we don't meet 100% of a job description's criteria - maybe you're feeling that way right now? We encourage you to apply anyway. Because we want you to be you, with us.

Tandem is firmly committed to being an equal opportunity employer and does not discriminate on the basis of age, disability, sex, race, religion or belief, gender identity or expression, marriage/civil partnership, pregnancy/maternity, or sexual orientation. We are an inclusive organization, and we welcome applications from a wide range of candidates. Selection for roles will be based on individual merit alone.

REFERRALS:
We love a good referral! If you know someone who would be a great fit for this position, please share!

APPLICATION DEADLINE:
The position will be posted until a final candidate is selected for the requisition or the requisition has a sufficient number of applications.

Make a move that matters. Join Tandem Diabetes Care, where we're turning challenges into triumphs every day and where your talents will help shape a healthier, happier tomorrow.