What are the responsibilities and job description for the R&D/QA Eng Tech - (Medical Devices) position at TekOne IT Services Pvt. Ltd.?
Role: R&D/QA Eng Tech
Location: Irvine, CA - 92614
Duration: 12 Months
Shift Timings: 8 to 5
Summary
Job Description:
Location: Irvine, CA - 92614
Duration: 12 Months
Shift Timings: 8 to 5
Summary
Job Description:
- 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 a variety of test equipment to assess characteristics of the manufacturing environment.
- Consult with Engineers, Technicians, and Assemblers on processes to execute experiments and/or production runs. 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.
- Utilize manufacturing software (e.g., JDE, QMS,PLM) to update documentation in systems.
- Follow through with development of training and documentation materials, based on collaboration with Engineering, including identifying opportunities for modification and making recommendations, enabling the seamless knowledge transfer of project and manufacturing processes; 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 manufacturing processes, 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 Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
- 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
- Substantial knowledge of validation and improvement of automated equipment
- Ability to troubleshoot manufacturing equipment
- Knowledge of material compatibility in the proposed use environment
- H.S. Diploma or equivalent
- 0-2 years of experience required
