Manager, Manufacturing Engineering

Growth 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.

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 leadership and direction for Manufacturing Engineering. Responsible for all aspects of manufacturing engineering of infusion sets. Contributes to both sustaining and new development efforts, including all aspects of new product introduction. Responsible for manufacturing development planning and execution for prototype, pilot, and production design transfer. Responsible for defining, managing, and reducing product costs throughout the life cycle of the product.

Supervises a team of engineers and technicians in support of supplier, process, process automation, failure analysis, and manufacturing engineering.

• Develops and defines automated and manual assembly techniques, tooling, and contributes to electro/mechanical testing development to improve product manufacturability.
• Directs troubleshooting on systems that either cause or potentially cause work stoppage and reduced throughput times.
• Supports operations with the creation of BOMs, DMRs, DHFs, (e)
  DHRs, work orders, work instructions, test methods, product costs, and metrics.
• Creates and measures applicable metrics, such as cost, schedule adherence, yield, etc.
• Responsible for meeting product cost targets and defining and implementing product cost activities.
• Initiates and implements continual process improvement activities through Kaizen events, Lean Manufacturing and Six Sigma designed to optimize process efficiency, reduce costs and lead‑times.
• Leads teams in the implementation of Lean Manufacturing and 6‑sigma techniques.
• Participates in Sustaining Engineering activities, including design improvements in support of improved manufacturing and testing of company’s products.
• Reviews Process Capability Analysis (Cpk).
• Develops equipment and process requirements and/or validation protocols/reports.
• Responsible for DOE, IQ OQ PQs, including writing and executing protocols.
• Specifies and/or validates test processes and equipment to be used by external suppliers and assists in reviewing Supplier Capability.
• Provides training and leadership to manufacturing personnel on procedure, process, and equipment changes.
• Works with the Quality and R&D groups, determines root cause through failure investigation, and develops and implements corrective and preventive action, as required.
• Works closely with R&D and Design Engineering to aid in the transition of new products and processes to manufacturing.
• Works closely with Contract Manufacturer(s) to aid in:
  Analyzes and assesses vendor capability to support development and/or high‑volume manufacturing.
• Participates in the selection, development, performance appraisal, merit recommendation, and promotion of department staff.

Hybrid:
This role will be a mix of in‑office work at our Barnes facility in San Diego, CA or Irvine, CA location and remote work. This position is expected to be in office 2‑3 days per week but may vary depending on business demands.

• Solid knowledge and application of principles outlined in Quality System Regulations (QSRs/GMPs).
• Proficient with MS Office and knowledgeable of Solidworks software.
• Ability to effectively use Microsoft Word, Excel, and PowerPoint for effective management reporting…