Process Design / Equipment Engineer

Job description

Project Planning & Timeline Definition

• Participate in early project phases (projects, pre-projects, and exploratory studies) by contributing to project planning, gathering requirements, and defining equipment specifications.
• Define equipment and process design activities, establishing clear engineering tasks aligned with engineering and quality standards to ensure timely project delivery.

Equipment & Process Design, Installation and Validation

• Lead the design, development, and integration of equipment in compliance with ISO 13485 and applicable regulatory standards.
• Evaluate manufacturing solutions and ensure alignment with product and production requirements.
• Conduct gap analyses (technology, workforce, and capabilities) to ensure successful transfer to production.
• Perform risk analyses and identify critical success factors for equipment and p...