Sr. Manufacturing Engineer

Tandem Diabetes Care • Ruth, CA

2d • Onsite

About The Position

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: Provides technical leadership to the Manufacturing Engineering team under the guidance of the Manufacturing Engineering Manager. Performs all aspects of manufacturing engineering for Cartridge. Leads Manufacturing Engineering activities for both new development efforts, including all aspects of new product introduction, and sustaining. Responsible for projects that effect Safety, Quality, Delivery, Innovation and Cost.

Requirements

• 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.
• Experienced with MS Office, knowledge of Solidworks software desirable.
• B.S. degree in Science or Engineering or a related field, or equivalent combination of education and applicable job experience.
• 4 years of experience in medical device manufacturing.
• Experience in an FDA/GMP/ISO environment.

Nice To Haves

• Lean Manufacturing and 6 sigma experience.
• Experience in process design, development, test, and validation.

Responsibilities

• 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, and metrics: Develops and updates work instructions and bill of materials.
• Manages and releases change orders.
• Supports Manufacturing Engineering Management in applicable Metrics, such as cost, schedule adherence, yield, etc.
• Defines continual process improvement activities through Kaizen events, Lean Manufacturing and Six Sigma designed to optimize process efficiency, reduce costs and lead-times.
• Leads supplier development and qualification activities.
• Defines requirements for supplier manufacturing and test processes and assists in reviewing Supplier Capability.
• 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 to aid in the transition of new products and processes to manufacturing: Leads the development of production test plans, requirements, and specifications.
• Leads Operations, Manufacturing and Production leaders in Prototype Development Planning activities and pilot build 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.
• Other responsibilities as assigned.

Benefits

• Tandem offers health care benefits such as medical, dental, vision available your first day, as well as 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 (with accrual starting on day 1) and you will have access to a 401k plan with company match as well as an Employee Stock Purchase plan.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees