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Process Development Specialist
3 months ago
Job Name : Process Development Technician
Location : Carlsbad, CA
Duration : 6 months assignment and temp to permanent as per performance
Shift :7:00 am to 3:30 pm
Weekdays : Monday – Friday
Payrate: $17.00/hour [ Weekly Pay]
Job Summary:
The NPI Process Development Technician is responsible for following protocols to assemble medical devices, conduct quality control tests, and safely operate associated equipment. The Manufacturing Technician will also assist engineers with prototype pilot builds, process optimization, troubleshooting, root cause investigations, and completion of associated documentation.
Responsibilities:
• Assist engineers and scientists as they create, modify, and test products and processes.
• Execute medical device assembly builds according to on-the-job training and associated controlled documentation
• Complete all documentation according to GDP requirements
• Setup, operate, and conduct moderate to complex troubleshooting of various automated and semi-automated equipment.
• Manipulation of small medical device components requiring excellent dexterity
• Safe use of sharp objects such as blades and needles
• Wearing of PPE according to the requirements of the area, including lab coats, gloves, safety glasses, steel toe shoes, booties, hairnets, beard covers, etc.
• Performing medical device assembly of routine and repetitive nature
• Leveraging equipment and process knowledge to optimize settings and processes
• Adhering to best ergonomic practices and rotating assembly duties as appropriate
• Inspect products and evaluate processes for flaws and identify areas of improvement.
• Conduct tests and document data
• Conduct time studies and assist in Lead time assessments
• Support of project proposal creation
• Documentation of NCRs including root cause investigations and material dispositions
• Professional written and verbal communications to project stakeholders and MFG management
• Execute batch records and/or travelers within expected cycle times
• Assist with cycle count and inventory management activities
Education/Skills:
• High school diploma or equivalent required. Associates degree with 3+ years of related work experience preferred.
• Experience with ISO13485 and/or ISO9001 preferred.