Design Engineer

BEPC Inc. provides Specialized Engineering Solutions and IT Project Management services to Fortune 500 companies in the Life Science and Technology industries. BEPC Mexico, a division of BEPC Incorporated, provides and manages consulting services for Automotive and Medical device companies throughout Mexico and around the globe.

The Design Engineer will support manufacturing, validation, and product lifecycle activities by creating, modifying, and maintaining 3D models and technical drawings using SolidWorks. This role is responsible for managing engineering changes (CO, CN, CR) within Windchill, ensuring accurate documentation control and compliance in a regulated manufacturing environment. The position works closely with cross-functional teams including manufacturing, quality, and engineering to implement design updates and improvements.

KEY RESPONSIBILITIES:

• Create, modify, and release 3D models and 2D technical drawings using SolidWorks (preferably certified).
• Manage and execute Change Orders (CO), Change Notices (CN), and Change Requests (CR) within Windchill PLM system.
• Ensure proper documentation, revision control, and traceability of all engineering changes.
• Evaluate and implement design changes to meet manufacturing, validation, and quality requirements.
• Collaborate with cross-functional teams (Manufacturing, Quality, Validation, and Production) to review and approve design updates.
• Support Engineering Change Orders (ECOs) impacting parts, assemblies, and manufacturing processes.
• Maintain and update Bills of Materials (BOMs) and related documentation in Windchill.
• Generate and maintain detailed drawings, specifications, and design documentation aligned with applicable standards.
• Support validation activities (IQ/OQ/PQ) and ensure design compliance within regulated environments.
• Participate in root cause analysis and troubleshooting related to design or product issues.
• Provide technical support on the shop floor to assess the impact of design modifications.
• Ensure compliance with internal procedures, quality systems, and regulatory requirements.

QUALIFICATIONS:

• Bachelor’s degree in Mechanical Engineering, Mechatronics Engineering, Manufacturing Engineering, or related field.
• Minimum 3–5 years of experience in design engineering within a manufacturing environment.
• Strong experience with SolidWorks (Certification such as CSWA/CSWP preferred).
• Hands-on experience managing CO, CN, and CR processes.
• Experience using Windchill (PLM system) for document and change control.
• Ability to interpret technical drawings, specifications, and engineering documentation.
• Knowledge of BOM management and revision control.
• Strong problem-solving and analytical skills.
• Effective communication and teamwork skills.
• Intermediate to advanced English proficiency (written and verbal).

PREFERRED QUALIFICATIONS:

• Experience in medical devices or regulated industries.
• Familiarity with FDA, ISO 13485, or GMP environments.
• Exposure to validation processes (IQ/OQ/PQ).
• Experience with AutoCAD (plus).
• Knowledge of configuration management and product lifecycle processes.