Responsibilities 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 process implementation.
Prepare engineering requirements, business cases, and CAPEX proposals for new eq...