Sr. 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:

Sr. Manufacturing Engineers at Tandem are also responsible for:

• Supports the technical development of automated and manual assembly techniques/tooling and identifies electro/mechanical testing development to improve product manufacturability.

• Supports operations with the creation/routing of BOMs, DHRs, Part Numbers, work instructions, drawings, inspection requirements, and metrics:

• Manages and releases change orders.
• Manages design change assessments as applicable.
• Supports Manufacturing Engineering Management in applicable Metrics, such as cost, schedule adherence, yield, lot tracking, etc.

• Defines continual process improvement activities through review of metrics, Kaizen events, Lean Manufacturing, and/or Six Sigma designed to optimize process efficiency, reduce costs, and minimize line down time.
• Leads supplier development and qualification activities.

• Defines requirements for supplier manufacturing and test processes and assists in reviewing Supplier Capability.
• Supports identification of second sourcing opportunities.

• Provides training to manufacturing personnel on procedure, process, and equipment changes.
• Working with the Quality and R&D groups, leads root cause failure investigations, and develops and implements corrective and preventive action, as required.
• Tools include PFMECA, FMECA, DOE, Fault Tree analysis.
• Supports R&D and Design Engineering in the transition of new products and processes to manufacturing:
  • Leads the development of production test plans, requirements, and specifications.
  • Partners with Quality to qualify equipment and/or processes as required.
  • Leads Operations, Manufacturing, and Production leaders in Prototype Development Planning activities and pilot build activities.
• Supports Manufacturing Engineering in the transition of products and processes to CM:
  • Leads knowledge and document transfers.
  • Confirms new processes/equipment at CM are equivalent in performance.
  • Confirms new documentation at CM is accurate/equivalent in content.
  • Assists in process validation activities.
• Confirms completion of required training plan before assuming job responsibilities.
• Ensures work is performed in compliance with company policies including Privacy/HIPAA and other regulatory, legal, and safety requirements.

WHEN & WHERE YOU'LL WORK:

This role will be a mix of in-office work at our Barnes Canyon facility and remote work. This position is expected to be in office 4 days per week but may vary depending on business demands.

This role will require car and air travel up to 30% of time, primarily day trips to in Tijuana & Santa Clarita, and some week long trips to the mid-west.

WHAT YOU'LL NEED:

• B.S. degree in Science or Engineering or a related field, or equivalent combination of education and applicable job experience.
• 4-6 years of experience in medical device manufacturing.
• Experience in an FDA/GMP/ISO environment.
• Awareness of federal and other regulations, e.g., QSRs, ISO 14971 IEC 60601 series.
• Knowledge of Good Documentation Practices (GDP).
• Good analytical and organizational skills with the ability to prioritize workload.
• Skilled at clearly conveying in-depth knowledge to all levels within, and outside of, the organization.
• Skilled at creating a cooperative team environment.
• Ability to objectively evaluate situations and make recommendations for changes in light of overall project demands.
• Ability to lead effective and efficient meetings with clear objectives and the necessary stakeholders.
• Experienced with MS Office and Minitab

EXTRA AWESOME:

• Lean Manufacturing and Six Sigma.
• Process design, development, test, and validation.
• Manufacturing within a clean room environment.
• Working with and supporting CM.
• Working with and supporting a global supply chain.
• Knowledge of SolidWorks software.

COMPENSATION & BENEFITS:

The starting base pay range for this position is $109,000 to $135,000 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 and a robust benefits package.

YOU SHOULD KNOW:

Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable state and local Fair Chance laws and regulations. A conditional offer of employment from Tandem is contingent upon successful completion of a pre-employment screening process comprised of a drug test (excluding marijuana) and background check, which includes a review of criminal history information.

Tandem has good cause to conduct a review of criminal history information of candidates for this position, as this role may involve access to proprietary, sensitive and/or confidential information, including customer protected health information. This review is required to ensure that individuals in such roles uphold high standards of trust and integrity so as to protect the interests of our customers, employees, and stakeholders.

SPONSORSHIP:

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.

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.

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