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Equipment Validation Engineer
Yorba Linda, CA, US
Engineering
Bachelors Degree
Full Time, Temporary
$45-50/hr
Experienced (Non-Manager)
On-site
Medical Devices and Supplies
First Shift (Day)
Yorba Linda, CA, US
$45-50/hr
Experienced (Non-Manager)
Full Time, Temporary
Medical Devices and Supplies
On-site
Engineering
Bachelors Degree
First Shift (Day)
Job details
Role Summary
The Equipment Validation Engineer supports the qualification and validation of CNC manufacturing equipment to ensure safe, compliant, and repeatable production. This role works with Manufacturing, Quality, Maintenance, EHS, suppliers, and engineering teams to introduce equipment, resolve technical issues, and sustain reliable production performance.
Key Responsibilities
The Equipment Validation Engineer supports the qualification and validation of CNC manufacturing equipment to ensure safe, compliant, and repeatable production. This role works with Manufacturing, Quality, Maintenance, EHS, suppliers, and engineering teams to introduce equipment, resolve technical issues, and sustain reliable production performance.
Key Responsibilities
- Lead validation activities for CNC lathes, Swiss-type machines, multi-axis machining centers, and related equipment.
- Develop and execute IQ/OQ/PQ protocols, test plans, deviations, and final reports.
- Verify CNC process parameters, including tooling, offsets, feeds, speeds, coolant, workholding, probing, and operating ranges.
- Plan and execute process capability studies for machined components.
- Support FAT/SAT, installation, commissioning, training, and handoff to Operations.
- Investigate equipment or process issues and drive corrective actions to improve uptime, yield, and reliability.
- Maintain the validated state of CNC equipment through change control, requalification, calibration, preventive maintenance, and documentation updates.
- Ensure validation activities follow quality system, safety, and documentation requirements.
Required Qualifications
- Bachelor’s degree in Engineering or a related technical field; equivalent experience may be considered.
- 3-5 years of experience in equipment validation, manufacturing engineering, process engineering, or equipment qualification.
- Hands-on experience with CNC equipment, tooling, fixtures, workholding, machine setup, and inspection methods.
- Experience developing validation protocols, reports, and technical documentation.
- Knowledge of CNC process variables, engineering drawings, GD&T, process capability, and statistical methods.
- Understanding of quality systems, change control, risk management, CAPA, and good documentation practices.
- Strong communication, troubleshooting, technical writing, and teamwork skills.
- Knowledge of metrology systems such as CMM, optical measurement, surface finish testing, and precision gauges.
Preferred Qualifications
- Experience in medical device, aerospace, automotive, or other regulated manufacturing environments.
- Familiarity with ISO 13485, FDA quality system requirements, GMP, and audit readiness.
- Experience with new equipment introduction, process transfers, CNC equipment replacement, or capacity expansion.
Work Environment & Travel
- This position is based at the Yorba Linda, CA manufacturing site and is intended to support local operations.
- Work includes time in office and on the manufacturing floor, with appropriate PPE and adherence to site safety requirements.
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