Manufacturing Technician 2

Job Description

Job Description

Manufacturing Technician 2
San Clemente CA
6 Months (Possibility of extension)

Vertical Description:
CONTRIBUTE TO DEVELOPMENT OF NEW DESIGNS, MANUFACTURING PROCESSES, AND OTHER ENGINEERING / BUSINESS PROCESSES AT ALL STAGES, FROM CONCEPT CREATION TO PRODUCTION RELEASE Assembles implantable Class III ophthalmic medical devices and the associated insertion system or subcomponents of the device and system. Complete component inspection and cleaning per SOPs and DHRs and records all records as required by the QA system. Complete subassembly and top level assembly fabrication and inspection per SOPs and DHRs and records all records as required by the QA system. Complete package assembly activities per SOPs and DHRs and record all records as required by the QA system. Responsible for generating or editing SOPs and DHRs to support development work. Provide support to engineering testing as needed by executing tests methods with detailed to limited definition, depending on the technician level. Responsible for generating proper documentation as required by engineering test protocols, engineering test reports, validation protocols, validation reports and other associated engineering lead tasks. Leads other technicians and team members to ensure project build activities are successful (For Level III and Level IV only). Work is completed to ensure safe and effective products that meet all worldwide quality, regulatory, marketing requirements. This works is accomplished with: Junior Engineering Technician (Level I) - With direction from management or engineering staff on task development and execution. Work will be done with direct oversight and will be reviewed for accuracy and overall content upon completion. Engineering Technician (Level II) - With direction from management or engineering staff on task development and execution. Work will be typically done with some oversight and will be reviewed for accuracy and overall content upon completion. Senior Engineering Technician (Level III) - With direction from management or senior engineering staff on task development and execution. Work will be typically done with limited oversight and will sometimes be reviewed for accuracy and overall content upon completion. Senior II Engineering Technician (Level IV) - With direction from management or senior engineering staff on task development and execution. Work will be done with minimal overview, for accuracy and overall content upon completion. Further, this technician will assist in reviews of other technician s work for accuracy and content and may be a Subject Matter Expert in a given technical area. Principal Engineering Technician (Level V) - With direction from management or senior engineering staff on task development and execution. Work may, but is often not, reviewed for accuracy and overall content upon completion. Further, this technician will assist in project leadership as a technical leader and act as a subject matter expert (SME) on projects or subprojects. Other duties as Assigned Additional other duties and projects as required to facilitate Production, Engineering, Clinical and Quality Assurance goals and objectives.

Responsibilities 
Perform kitting operations (measure out components or raw materials)
Ability to perform activities under a microscope
Prepare components and build device assemblies
Perform packaging and labeling operations
Perform sampling
Perform visual inspections
Perform documentation and data input into materials requirement planning (MRP), Batch Records (BRs), and Device History Record (DHR)
Perform all activities with good documentation practices (GDP) in accordance with current good manufacturing practices (cGMPs) and quality management system (QMS) medical device good manufacturing practices (GMP) requirements.
Additional tasks as required
Maintain proper cleanroom environment (including gowning, room cleaning, and supplies)
Follow, execute, and adhere to documentation in accordance with cGMP, QMS, and GDP requirements: protocols, specifications, work instructions (WIs), standard operating procedures (SOPs), batch records (BRs), device history records (DHRs), and engineering batches.
Perform basic calculation and data entry
Ability to assemble, disassemble, and clean process equipment
Ability to clean, etch, passivate, assemble, and inspect components
Process and assemble components in accordance with documented specifications and procedures
Perform packaging and labeling operations
Perform in-process inspection of assemblies and finished products in accordance with specification criteria
Organize and clean the work areas
Ability to perform validation and qualification activities (IQ/OQ/PQ/PV)
Requirements:
Experience
Level I 0 to 3 years engineering or production technician work. Medical device experience a plus. Level II 4 to 7 years of work experience in a production or engineering environment and 3 years as an engineering technician work. 3 years of medical device experience required. Level III 8 to 12 years of work experience in a production or engineering environment and 5 years as an engineering technician work. 5 years of medical device experience required, 10 years preferred. 2 years of leadership experience preferred. Level IV 12-15 years of work experience in a production or engineering environment and 8 years as an engineering technician work. 5 years of medical device experience required, 10 years preferred 3 years of leadership required, 5 years preferred. Level V 15 years of work experience in a production or engineering environment and 8 years as an engineering technician work or engineer work. Ability to act as SME on projects or critical components/assemblies/processes. 8 years of medical device experience required, 10 years preferred 3 years of leadership required, 5 years preferred.

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