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    Manufacturing Engineer - San Diego, United States - Tandem

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    Description
    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

    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.

    YOU'RE AWESOME AT:
    • Creates, manages, and releases change orders.
    • Develops and updates work instructions, work orders, BOM's, quality specifications, and test methods.
    • Ability to identify opportunities and techniques to streamline existing processes.
    • Troubleshooting 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.
    • Understanding of mechanical drawings & specifications including geometric dimensioning and tolerances (GD&T).
    • 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.
    • Knowledge and application of principles outlined in Good Manufacturing Processes (GMP).
    • Ability to maintain and enforce Good Documentation Practices (GDP).
    • Ensures compliance with company policies, including Privacy/HIPAA, and other legal and regulatory requirements.
    EXTRA AWESOME:
    • B.S. degree in Science or Engineering or a related field, or equivalent combination of education and applicable job experience.
    • 1+ years' experience in medical device manufacturing.
    • Ability to travel internationally and domestically.
    • Experience in a FDA/GMP/ISO environment.
    • Lean Manufacturing and 6 sigma experience.
    • Experience in process design, development, test, and validation.
    • Knowledge of Good Documentation Practices (GDP).
    • Familiar with product specifications, test specifications, process specifications.
    • Some integration experience in a manufacturing environment, to assist with the transfer of testing methodology to manufacturing.
    • 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.
    • Able to work effectively in a team environment
    • Advanced skills with 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.
    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

    BE YOU, WITH US

    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.

    COMPENSATION & BENEFITS:

    The starting base pay range for this position is $70,800 - $80,400 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 11 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

    YOU SHOULD KNOW:

    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.

    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.

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

    REFERRALS:

    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:

    #LI-Hybrid #LI-DW1


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