EXPERIENCE IN THE MEDICAL DEVICE INDUSTRY IS REQUIRED.

Validation Engineer – Design

Location: Ciudad Juárez, Chihuahua
Company: BEPC Inc.

BEPC Inc. is seeking a Validation Engineer with a strong focus on product design and engineering changes. The adecuado candidate will have experience using SolidWorks and Windchill, managing change-control processes, and developing or executing validation protocols in the medical device industry.

Key Responsibilities

- Support product design, design changes, and engineering documentation using SolidWorks.
- Create, review, and manage Change Notices (CN), Change Requests (CR), and Change Orders (CO).
- Maintain product documentation and engineering changes within Windchill.
- Develop, review, execute, and document IQ, OQ, and PQ validation protocols.
- Support design transfer, process improvements, and the implementation of new or modified products and equipment.




- Ensure engineering and validation activities comply with applicable quality-system and regulatory requirements.
- Collaborate with Engineering, Quality, Manufacturing, and other cross-functional teams.
- Prepare technical reports, validation documentation, and change-control records.

Qualifications

- Bachelor’s degree in Engineering or a related technical field.
- Experience in the medical device industry is required.
- Experience with SolidWorks and design-related engineering activities.
- Experience with Windchill and CN, CR, and CO change-control processes.
- Knowledge of IQ, OQ, and PQ validation protocols.
- Recent experience at Biosense Webster (BWI) is preferred.
- Intermediate technical English proficiency.
- Strong documentation, problem-solving, and cross-functional communication skills.

MXOPS

Job Type: Full-time

Pay: $100.00 - $200.00 per month

Work Location: In person

📌 Ingeniero de Validación & Diseño - 29762 (México)
🏢 Bepc
📍 México