Manufacturing Engineering Technician II (3 Month Contract)

Tandem Diabetes Care

27d•$25 - $31•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: Performs functions associated with all manufacturing operations. Works with engineers in set-up and development of support processes. Assists in the development and execution of protocols and test runs. Design, implement and maintain production support processes. Assess manufacturing processes for compliance with written policies and procedures including QSR’s and cGMP practices. Assembles and initiates documentation change order packages. Proactively communicates notifications on problems and issues. Manufacturing Engineering Technician II's at Tandem are also responsible for: Maintains, operates and develops processes in support of manufacturing operations. Performs assessments of procedures within the manufacturing environment, identifying non-conformances, recommending and implementing corrective and preventative actions. Performs all manufacturing assignments in accordance with established safety procedures and applicable regulatory requirements. Contributes to and develops equipment operating procedures (EOPs) and preventative maintenance (PMs) plans as requested. Develops and releases written and picture-based work instructions. Participates in continual process improvement activities designed to optimize quality, compliance, process efficiency, and lead times. Executes process validation and qualification protocols and documents results and findings as required. Provides training, as required, to production personnel on procedure, and process changes. Assists in the implementation Lean Manufacturing and 6 sigma techniques. Other duties as assigned.

Requirements

Knowledgeable with QSRs.
Must have strong cGMP documentation skills.
Working knowledge of small scale electromechanical device assembly operation
Ability to effectively share information regarding issues in written or verbal form and making recommendations in a clear and concise manner.
Skilled at promoting team cooperation and a commitment to team success.
Demonstrated ability to effectively prioritize and handle multiple priorities and complete assignments on time and with minimal errors.
Proficient with Microsoft Office and Internet.
Associate degree in a technical discipline, or applicable job experience and education.
4+ years of experience in Instrumentation or Biomedical Industries, or Consumer Electronics.
Experience in FDA/GMP/ISO environment.

Nice To Haves

Lean Manufacturing experience desirable.

Responsibilities

Performs functions associated with all manufacturing operations.
Works with engineers in set-up and development of support processes.
Assists in the development and execution of protocols and test runs.
Design, implement and maintain production support processes.
Assess manufacturing processes for compliance with written policies and procedures including QSR’s and cGMP practices.
Assembles and initiates documentation change order packages.
Proactively communicates notifications on problems and issues.
Maintains, operates and develops processes in support of manufacturing operations.
Performs assessments of procedures within the manufacturing environment, identifying non-conformances, recommending and implementing corrective and preventative actions.
Performs all manufacturing assignments in accordance with established safety procedures and applicable regulatory requirements.
Contributes to and develops equipment operating procedures (EOPs) and preventative maintenance (PMs) plans as requested.
Develops and releases written and picture-based work instructions.
Participates in continual process improvement activities designed to optimize quality, compliance, process efficiency, and lead times.
Executes process validation and qualification protocols and documents results and findings as required.
Provides training, as required, to production personnel on procedure, and process changes.
Assists in the implementation Lean Manufacturing and 6 sigma techniques.
Other duties as assigned.