Manufacturing Engineering Technician II (3 Month Contract)

Tandem Diabetes Care Europe B.V.; California; Presencial; USD 35.000 - 43.000; Jornada completa

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Descripción de la vacante

Tandem Diabetes Care is seeking a Manufacturing Engineering Technician II for an onsite role in San Diego, California. You will work with engineers to set up and develop production support processes, and you will assist in protocol development, validation, and documentation.

The position emphasizes QSR/cGMP compliance, documentation discipline, and participation in continuous process improvement initiatives. 4+ years in relevant industries and an associate technical degree are preferred.

Formación

• Associate degree or equivalent technical experience.
• 4+ years in Instrumentation, Biomedical, or Consumer Electronics.
• Experience in FDA/GMP/ISO environments.
• Lean Manufacturing experience desirable.

Responsabilidades

• Maintain and improve production support processes.
• Develop and execute protocols and test runs.
• Ensure compliance with QSRs and cGMP.
• Provide documentation and training as needed.
• Assist in Lean and Six Sigma initiatives.

Descripción del empleo

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.

WHEN & WHERE YOU'LL WORK:

Onsite: This position is fully onsite and open to candidates located in San Diego, California. Equipment for the role will be provided and training will occur onsite.

Schedule: This position will work Monday - Thursday from 2:30 PM - 1:45 AM PST .

WHAT YOU'LL NEED:

1. Knowledge, skills & abilities:
   
   
   
   • 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.
   
   
   
   


2. Minimum certifications/educational level:
   Associate degree in a technical discipline, or applicable job experience and education.
   


3. Minimum experience:
   4+ years of experience in Instrumentation or Biomedical Industries, or Consumer Electronics.
   Experience in FDA/GMP/ISO environment.
   Lean Manufacturing experience desirable.
   

COMPENSATION:

The starting base pay range for this position is $25.19 to $31.47 per hour. Base pay will vary based on job-related knowledge, skills, experience and may also fluctuate depending on candidate's location and the overall job market.

Please note that is a temporary position. As a temporary employee you will be employed through a staff agency partner. Benefits during your temporary assignment may be provided by the staffing agency. Access to Tandem sponsored benefits is contingent upon conversion from temporary to regular full-time status. Conversion is determined based upon business need and job performance.

YOU SHOULD KNOW:

Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable state and local Fair Chance laws and regulations. A conditional offer of employment from Tandem is contingent upon successful completion of a pre-employment screening process comprised of a drug test (excluding marijuana) and background check, which includes a review of criminal history information.

Tandem has good cause to conduct a review of criminal history information of candidates for this position, as this role may involve access to proprietary, sens