R&D/QA Engineering Technician – Light Industrial

R&D/QA Engineering Technician – Light Industrial

Location: Irvine, CA Contract Length: 6 months Pay Range: $21.50 – $26.50/hr




Summary: The main function of this technician role is to set up and execute feasibility studies, experiments, and tests — both creating and following established protocols — to develop findings for the validation and improvement of equipment and manufacturing processes/methods based on engineering principles. The technician will analyze results, make recommendations, and develop reports for Engineering review, while operating a variety of test equipment to assess characteristics of the manufacturing environment.




Job Responsibilities: In this role, you will support a variety of projects within the R&D/QA Engineering department in a clean room medical device manufacturing environment. Key responsibilities include:




Essential Job Duties and Job Functions:

• Consult with Engineers, Technicians, and Assemblers on processes to execute experiments and/or production runs; support equipment investigations, testing, objective evidence of product dispositions, and rework as needed
• Review documentation and take appropriate action to ensure information is properly catalogued, following through to validation and qualification of equipment, including transferring information to ECRs, SOPs, drawings, and tooling for Engineering approval
• Utilize manufacturing software (e.g., JDE, QMS, PLM) to update documentation in relevant systems
• Develop training and documentation materials in collaboration with Engineering, identifying opportunities for modification and enabling seamless knowledge transfer of project and manufacturing processes
• Apply process knowledge to devise process changes in collaboration with Engineering
• May lead projects related to new equipment validation, equipment investigations, testing, objective evidence of product dispositions, and rework
• Identify potential improvement opportunities and propose solutions to optimize processes and/or equipment (e.g., redesign of basic equipment, tools, and fixtures) for Engineering review
• Provide coaching and guidance to technicians

Knowledge and Skills:

• Excellent computer skills required, including MS Office Suite; ERP/MRP systems experience preferred
• Ability to read, comprehend, write, and speak English, with good communication skills
• Knowledge of and adherence to Environmental Health and Safety and Quality guidelines relevant to clean room medical device manufacturing
• Knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) in a medical device environment
• Strict attention to detail
• Ability to provide feedback in a professional, direct, and tactful manner
• Ability to work effectively in a team environment with minimal supervision
• Proven success adhering to project schedules and managing small projects
• Substantial knowledge of validation and improvement of automated equipment
• Ability to troubleshoot manufacturing equipment
• Knowledge of material compatibility in the proposed use environment

Education and Experience:

• H.S. Diploma or equivalent required
• 0–2 years of relevant experience required

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