Design Engineer

About the role

The Design Engineer will support manufacturing, validation, and product lifecycle activities by creating, modifying, and maintaining 3D models and technical drawings. You will work closely with cross‑functional teams to implement design updates in a regulated environment.

Key responsibilities

• Create, modify, and release 3D models and 2D drawings using SolidWorks.
• Manage Change Orders (CO), Change Notices (CN) and Change Requests (CR) in Windchill PLM.
• Maintain documentation control, revision tracking and traceability.
• Update Bills of Materials (BOMs) and related records.
• Collaborate with Manufacturing, Quality, Validation and Production to review and approve design changes.
• Support validation activities (IQ/OQ/PQ) and ensure regulatory compliance.
• Provide technical support on the shop floor and participate in root‑cause analysis.

Required profile

• Bachelor’s degree in Mechanical, Mechatronics, Manufacturing Engineering or related field.
• 3–5 years of design engineering experience in a manufacturing setting.
• Strong knowledge of regulated environments (FDA, ISO 13485, GMP) is a plus.
• Intermediate to advanced written and spoken English.

Required skills

• SolidWorks (CSWA/CSWP certification preferred).
• Windchill PLM for document and change control.
• BOM management and revision control.
• Technical drawing creation and interpretation.
• Change Order, Change Notice and Change Request processes.
• AutoCAD (optional).