Senior R&D/QA Engineering Technician

Cynet Systems•Irvine, CA

1d•Onsite

About The Position

The Senior R&D/QA Engineering Technician will consult with Engineers, Technicians, and Assemblers on processes to execute experiments and/or production runs. This role provides support related to equipment investigations, testing, objective evidence of product dispositions, and necessary rework support work. The technician will review documentation, ensure information is appropriately cataloged, and follow through with validation and qualification of equipment. They will transfer information to appropriate locations for Engineering approval, utilize manufacturing software to update documentation, and develop training and documentation materials in collaboration with Engineering. This role identifies opportunities for modification and makes recommendations for seamless knowledge transfer of project and manufacturing processes. The technician will apply knowledge of processes to devise process changes, lead projects related to new equipment validation, equipment investigations, testing, objective evidence of product dispositions, and rework. They will identify potential improvement opportunities and propose solutions to optimize processes and/or equipment, such as re-design/design of basic equipment, tools, and fixtures. Additionally, the role provides coaching and guidance to technicians, sets up and executes feasibility studies, experiments, and tests, analyzes results, makes recommendations, and develops reports for Engineering review. The technician will operate a variety of test equipment to assess characteristics of the manufacturing environment.

Requirements

H.S. Diploma or equivalent.
3-5 years of experience required.
Foundation in laboratory testing and inspection.
Basic understanding of medical device inspection or testing concepts.
Ability to perform hands-on testing and operate laboratory or inspection equipment.
Ability to interpret and follow testing procedures and instructions.
Strong verbal and written communication skills and the ability to work effectively with engineers and technicians.
Excellent computer skills required, including experience with MS Office Suite.
Knowledge of and adherence to the Environmental Health and Safety and Quality guidelines as they relate to department 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.
Ability to work onsite every scheduled workday.
Ability to perform repetitive push/pull activity.
Ability to apply approximately 5–25 pounds of force.
Ability to perform hands-on laboratory and testing work.

Nice To Haves

ERP/MRP systems experience preferred.
Manufacturing or prototype experience when combined with relevant testing aptitude.
Dimensional measurement, Keyence, or GD&T exposure.
Tensile or similar mechanical testing experience.

Responsibilities

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.
Transfer 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.
Identify opportunities for modification and making recommendations, enabling the seamless knowledge transfer of project and manufacturing processes.
Apply knowledge of processes to devise process changes in collaboration with Engineering.
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.
Provide coaching and guidance to technicians.
Set-up and execute feasibility studies, experiments, and tests - both creating and following established protocols.
Analyze results, make recommendations, and develop reports for Engineering review.
Operate a variety of test equipment to assess characteristics of the manufacturing environment.