Principal Manufacturing Engineer

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 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 https://www.tandemdiabetes.com/

WHEN & WHERE YOU’LL WORK:

This role is on-site five days a week at our Barnes Canyon office due to the nature of the work involved.

This position has a schedule Monday  - Friday day shift

A DAY IN THE LIFE:

A highly skilled senior team member who provides technical product and process/project leadership to the Manufacturing Engineering team.  Performs all functionalities associated with manufacturing engineering for electromechanical insulin pumps and disposable devices, including peripherals.  Responsible for sustaining aspects of new product introduction/design transfer; design for manufacturability and assembly, phase gate deliverables, pilot line transfer into production, first production volume lines released, then further development of product and its parts and processes advancing to maturity. Responsible for identifying new manufacturing processes, test methods, and manufacturing methods to reduce product cost throughout the life cycle of the product.

Principal Manufacturing Engineers at Tandem are also responsible for:

• Identifies, owns, and delivers design for manufacturability and assembly, new product process and quality specifications and associated documentation.
  • Identify and drive design for manufacturability and assembly
  • Leads the development of production test plans, requirements and specifications.
  • Leads the technical development of automated and manual assembly techniques, tooling, and identifies electro/mechanical testing development to improve product manufacturability.
• Defines new product component quality/qualifications.
  • Leads supplier development and qualification activities.
  • Defines requirements for supplier manufacturing and test processes and assists in reviewing Supplier Capability.
• Able to support and possibly manage operations including material needs and staffing for all level of product life starting with DVT builds through maturity and volume support output.
• Provides technical direction on troubleshooting of disposable, mechanical, electrical and pneumatic systems, which either cause or potentially cause work stoppage, reduced throughput times, or product non-conformances.
  • Leads root cause failure investigations and develops/implements corrective and preventive action, as required.
• Supports Manufacturing, Production and Supply Chain in applicable Metrics, such as cost, schedule adherence, yield, stability, etc.
• Defines continual process improvement activities through Kaizen events, Lean Manufacturing and Six Sigma designed to optimize process efficiency, reduce costs and lead-times.
• Provides training to manufacturing personnel on procedure, process, and equipment changes.
• Confirms completion of the 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.

WHAT YOU’LL NEED:

REQUIRED QUALIFICATIONS:

Knowledge, skills & abilities:

• 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.
• Able to objectively evaluate situations and make recommendations for changes in light of overall project demands.
• Skilled a