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Tandem Diabetes Care · 1 day ago

Manufacturing Engineering Technician II (3 Month Contract)

California, United States

Full-time, Contract

Onsite

Mid Level

$25.19/hr - $31.47/hr

4+ years exp

Tandem Diabetes Care is a leader in the diabetes technology industry, committed to creating innovative products for people living with diabetes. The Manufacturing Engineering Technician II will perform various functions associated with manufacturing operations, ensuring compliance with safety and regulatory standards while contributing to process improvements.

Medical Device

No H1B

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

Qualification

QSR knowledgeCGMP documentationElectromechanical assemblyFDA/GMP/ISO experienceLean ManufacturingMicrosoft OfficeProcess improvementPrioritization skillsTeam cooperation

Required

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

Preferred

Lean Manufacturing experience desirable

Company

Tandem Diabetes Care

Glassdoor3.6

Tandem Diabetes Care, a global insulin delivery and diabetes technology company, manufactures and sells advanced automated insulin delivery systems that reduce the burden of diabetes management, while creating new possibilities for patients, their loved ones, and healthcare providers.

Founded in 2006

San Diego, California, US

1001-5000 employees