Tech, R&D/QA Eng
1411 McGaw Ave Irvine, CA 92614 US
The main function of a technician 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; analyze results, make recommendations, and develop reports for Engineering review. Operate and maintain a variety of test equipment to evaluate valve technology.
- Consult with Engineers, Technicians, and Assemblers on processes to execute experiment. Support related to equipment investigations, testing, objective evidence of product dispositions and rework support work necessary.
- Review documentation and take appropriate actions to ensure that information is appropriately catalogued and follow through to validation and qualification of equipment, including transferring information to appropriate locations, e.g., ECRs, SOPs, drawings, and tooling, for Engineering approval.
- Follow through with development of training and documentation materials, based on collaboration with Engineering, including identifying opportunities for modification and making recommendations, applying knowledge of processes 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 process and/or equipment, e.g., re-design/design of basic equipment, tools, fixtures, etc. to improve testing, for Engineering review.
- Provide coaching and guidance to technicians.
- Excellent computer skills required, including experience with MS Office Suite; ERP/MRP systems experience preferred
- Ability to read, comprehend, write and speak English, and good communication skills required
- Knowledge of and adherence to Client Environmental Health and Safety and Quality guidelines as they relate to department medical device testing
- Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment
- Strict attention to detail
- Ability to provide feedback in a professional, direct, and tactful manner
- Must be able to work in a team environment and with minimum supervision
- Proven success adhering to project schedules and managing small projects
- Knowledge of validation and improvement of automated equipment
- Knowledge of material compatibility in the proposed use environment
- Experienced with preventative maintenance and maintaining equipment
Education and Experience:
- H.S. Diploma or equivalent
- 0-2 years of experience required
**salary will be commensurate with experience**
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