Engineering Technician

Position: Sr Technician, R&D/QA Engineering, Req# 19356-1
Location: Irvine, CA (100% onsite)

Duration: 6+ month c ontract with a high possibility of extension

Interview Process:

• Approximately four to five interviewers may participate.
• Interview participants are expected to include the hiring manager, the hiring manager's manager, current technicians, and at least one engineer.
• Interviews may be conducted as individual one-on-one conversations rather than one panel.
• Onsite interviews are preferred so candidates can see the laboratory and work environment.
• Virtual interviews are acceptable when onsite availability creates a scheduling barrier.
• The interview process should be coordinated quickly to reduce the risk of losing qualified candidates.

Role Overview Summary:

• Six-month contingent assignment supporting the R&D Tech QA Engineering team.
• Provides additional technician capacity while a current employee is on medical leave and during an anticipated period of increased laboratory testing.
• Primary focus is hands-on laboratory testing rather than prototype building.
• The technician will be placed across appropriate testing activities based on experience and demonstrated capability.

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.

Education and Experience:

• H.S. Diploma or equivalent
• 3-5 Years of experience required
• The preferred foundation is laboratory testing and inspection. Manufacturing or prototype experience is a secondary pathway when the candidate also demonstrates relevant testing aptitude and the ability to learn quickly.
• 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 communication skills and the ability to work effectively with engineers and technicians.
• Ability to work onsite every scheduled workday.

Candidate Profile Clarification:

• The manager is open to an early-career candidate but is not seeking a general entry-level manufacturing profile.
• The strongest candidates will have a foundation in laboratory testing, medical device inspection, or QA/QC.
• The client-specific equipment and processes can be taught; candidates do not need to be fully plug-and-play.
• Manufacturing and prototype-building experience may be considered, but testing experience is the higher priority because the lab expects increased testing demand during the second half of the year.

Additional Skills :

• 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 the client's 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

Work Environment and Physical Requirements:

• Fully onsite in an R&D laboratory; this is not a remote or hybrid assignment.
• This is not a cleanroom position.
• The laboratory supports ISO/lab and design-verification-related testing activities.
• Some testing equipment requires repetitive push/pull activity and the application of approximately 5-25 pounds of force.
• Candidate must be comfortable performing hands-on laboratory and testing work.

Team Fit and Soft Skills:

• Clear, professional communication with engineers at different levels, managers, and technicians.
• Flexibility to support different types of laboratory work within a large team.
• Willingness and ability to learn the client-specific equipment and testing methods.
• Collaborative work style and comfort operating in a cross-functional environment.

Key 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 as 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.

esting.
Primary focus is hands-on laboratory testing rather than prototype building.
The technician will be placed across appropriate testing activities based on experience and demonstrated capability.

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.

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, 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.

Additional Skills:
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

Education and Experience:
H.S. Diploma or equivalent
3-5 Years of experience required
The preferred foundation is laboratory testing and inspection. Manufacturing or prototype experience is a secondary pathway when the candidate also demonstrates relevant testing aptitude and the ability to learn quickly.
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 communication skills and the ability to work effectively with engineers and technicians.
Ability to work onsite every scheduled workday.

Candidate Profile Clarification:
The manager is open to an early-career candidate but is not seeking a general entry-level manufacturing profile.
The strongest candidates will have a foundation in laboratory testing, medical device inspection, or QA/QC.
Edwards-specific equipment and processes can be taught; candidates do not need to be fully plug-and-play.
Manufacturing and prototype-building experience may be considered, but testing experience is the higher priority because the lab expects increased testing demand during the second half of the year.

Work Environment and Physical Requirements:
Fully onsite in an R&D laboratory; this is not a remote or hybrid assignment.
This is not a cleanroom position.
The laboratory supports ISO/lab and design-verification-related testing activities.
Some testing equipment requires repetitive push/pull activity and the application of approximately 5-25 pounds of force.
Candidate must be comfortable performing hands-on laboratory and testing work.

Team Fit and Soft Skills:
Clear, professional communication with engineers at different levels, managers, and technicians.
Flexibility to support different types of laboratory work within a large team.
Willingness and ability to learn Edwards-specific equipment and testing methods.
Collaborative work style and comfort operating in a cross-functional environment.

Interview Process:
Approximately four to five interviewers may participate.
Interview participants are expected to include the hiring manager, the hiring manager s manager, current technicians, and at least one engineer.
Interviews may be conducted as individual one-on-one conversations rather than one panel.
Onsite interviews are preferred so candidates can see the laboratory and work environment.
Virtual interviews are acceptable when onsite availability creates a scheduling barrier.
The interview process should be coordinated quickly to reduce the risk of losing qualified candidates.

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