Role: R&D/QA Eng Tech
Location: Irvine, CA (100% Onsite)
Duration: 12 Months on
W2
Shift Timings: 8:00 AM to 5:00 PM
Job Description
The
R&D/QA Eng Tech will be responsible for setting up and executing feasibility studies, experiments, and tests. This role involves creating and following protocols for the validation and improvement of equipment and manufacturing methods, analyzing results, and developing reports for engineering review. The technician will operate test equipment to assess the characteristics of the manufacturing environment, working closely with engineers and team members.
Responsibilities
- Consult with Engineers, Technicians, and Assemblers on processes for executing experiments and production runs.
- Support equipment investigations, testing, and rework activities needed for product disposition.
- Review and catalog documentation and ensure proper validation and qualification of equipment, updating records in relevant systems (e.g., ECRs, SOPs, drawings, tooling).
- Use manufacturing software (e.g., JDE, QMS, PLM) to manage and update documentation.
- Assist with training material development and knowledge transfer of processes in collaboration with Engineering.
- Lead small projects related to equipment validation, testing, and improvement.
- Identify improvement opportunities and propose process or equipment optimizations for engineering review.
- Provide coaching and guidance to junior technicians.
Additional Skills
- Excellent computer skills including proficiency in MS Office Suite; ERP/MRP systems experience preferred.
- Strong communication skills and the ability to work both independently and as part of a team.
- Knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) in a medical device setting.
- Detail-oriented with strict attention to following established protocols.
- Ability to troubleshoot manufacturing equipment and collaborate on equipment design/redesign.
- Strong understanding of validation and improvement of automated equipment and material compatibility.
Education & Experience
- High School Diploma or equivalent required.
- 0-2 years of experience in a relevant role (experimentation, documentation, and equipment knowledge).