Manufacturing Engineer II

Tandem Diabetes Care

Irvine, CA


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.



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



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.  

  • Assessment and qualification of new suppliers and/or new Production/test equipment.
  • Partner closely with both internal (Operations, Quality, Supply Chain, PD, Marketing teams) and external (CM’s, Contractors, Equipment Suppliers) resources.
  • Develop accurate, detailed, and linked project schedules and other project tracking tools by partnering with internal and external stakeholders.
  • Creates, manages, and releases change orders.
  • Identifying opportunities and techniques to streamline existing processes.
  • Troubleshooting Production equipment, programs, and processes.
  • Collaboration with Quality and/or R&D engineer(s) to resolve Quality issues.
  • Tooling and Fixturing design, fabrication, and implementation.
  • Participation in initiatives to support continuous process improvement and real-time process metrics.
  • Maintain and enforce Good Documentation Practices (GDP).
  • Ensures compliance with company policies, including Privacy/HIPAA, and other legal and regulatory requirements.


  • Strong knowledge of and demonstrated experience with equipment qualifications (DOE, IQ/OQ/PQ), process validations, mold qualifications, TMV, and GR&R methodologies and requirements.
  • Understanding of mechanical drawings & specifications including geometric dimensioning and tolerances (GD&T).
  • Knowledge and application of principles outlined in Good Manufacturing Processes (GMP).
  • Knowledge of statistical techniques such as hypothesis testing (ANOVA) and confidence intervals.
  • Ability to forge strong, effective, and transparent relationships with vendors while also protecting Tandem’s interests.
  • Experience with clearly conveying knowledge to all levels within, and outside of, the organization.
  • Excellent skills in the following areas: verbal and written communication, interpersonal relationships, organization, and time-management.
  • 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 effectively use Microsoft Office suite, SolidWorks, Minitab, and other applicable software.
  • Ability to dive into details, translate and statistically analyze data, and effectively report results through written and/or graphical formats.
  • Ability to thoroughly investigate and troubleshoot problems, identify root cause(s), document findings, and implement appropriate corrective actions.
  • Ability to facilitate large and small group meetings effectively.
  • Capable of managing multiple priorities effectively and ability to research and recommend best course of action from several alternatives.



  • Ability to travel internationally and domestically is required.
  • 3 yrs. experience working in the following is preferred:
    • Operations
    • Medical device Manufacturing, or an ISO 13485 & FDA-regulated industry
  • Bachelor’s degree in Engineering, Biotechnology, or a related field of study; or equivalent combination of education and applicable job experience.



    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


    Tandem is firmly committed to being an equal opportunity employer and maintaining a diverse and inclusive environment. We value and embrace that every single one of us brings value 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.


    The starting base pay range for this position is $86,000 - $104,000 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, equity, and a robust benefits package.

    Tandem offers health care benefits such as medical, dental, vision, health savings accounts and flexible saving accounts.  You’ll also receive 10 paid holidays per year, a minimum of 20 days of paid time off (starting in year 1) and have access to a 401k plan with company match.  Learn more about Tandem’s benefits here!


    Potential new employees must successfully complete a drug screen (excludes marijuana) and background check which includes criminal search, education certification and employment verification prior to hire. 


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

    If you are applying for this job and live in California, please read Tandem’s CCPA Notice:


    Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

    #LI-Hybrid #LI-BC1