PREVIOUS EXPERIENCE AT BWI HIGHLY PREFERRED.

MUST HAVE EXPERIENCE IN MEDICAL DEVICE INDUSTRY, VALIDATIONS (IQ, OQ & PQ)

KEY RESPONSIBILITIES:
- Provide technical engineering support for validations, write and execute Installation Qualification (IQ) protocols, and provide data to write completion reports for assigned validations.
- Provide technical engineering support for validations, write and execute Operational Qualification (OQ) protocols, and provide data to write completion reports for assigned validations.
- Provide technical engineering support for validations, write and execute Computer Systems Validation (CSV) protocols.
- Provide technical engineering support for validations, write and execute Test Method Validation (TMV) protocols.
- Responsible for running experiments during the pre-validation phase, run other experiments as needed.
- Ensure that assigned validation activities are performed in a timely manner and in accordance with current requirements and Good Manufacturing Practices (GMP).




- Demonstrate sufficient knowledge in validation skills, GMP, Good Documentation Practices (GDP).
- Responsible for the execution of validation, including the creation of forms to create calibration and preventive maintenance records.

QUALIFICATIONS:
- Engineering Degree (master’s in science is a plus)
- 3 - 4 years of experience in medical industry
- Good presentation skills before groups/clients.
- Intermediate knowledge in statistics.
- Intermediate knowledge in Six Sigma, DMAIC and Kaizen.
- Advanced English proficiency
- Experience in validation activities and product knowledge of the following medical devices (MUST):
- OCTARAY Mapping Catheter
- THERMOCOOL SMARTTOUCH SF (STSF - Surround Flow) Catheter
- QDOT MICRO Catheter
- Valid U.S. tourist visa and availability to travel (REQUIRED).

MXOPS

Pay: $100.00 - $200.00 per hour

Work Location: In person

📌 Ingeniero de Validación Iii (Ciudad Juárez)
🏢 Bepc
📍 Ciudad Juárez