Sr. Manufacturing Engineer I

Tandem Diabetes Care•Ruth, CA

11d•$109,000 - $135,000•Hybrid

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 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.

Requirements

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

Nice To Haves

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.

Responsibilities

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.
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.