Sr. Manufacturing Engineer

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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.

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.

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Provides technical leadership to the Manufacturing Engineering team under the guidance of the Product Development Engineering group. Performs all aspects of manufacturing engineering primarily for a disposable inserter system. Leads Manufacturing Engineering activities for both new development efforts, including all aspects of new product introduction, and sustaining. This position will report to R&D during product development and then will transition to the Manufacturing Engineering group to support scale-up, automation, and process transfer to a Contract Manufacturer (CM).

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.

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.

• B.S.…