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 process implementation.
• Prepare engineering requirements, business cases, and CAPEX proposals for new equipment and processes.
• Develop equipment specifications, manage supplier selection, conduct tender evaluations, and support purchase order awards.
• Lead design reviews (internal and external) and manage investment projects using structured project management methodologies.
• Ensure proper qualification and validation activities, including FAT, SAT, IQ, and participation in process validation activities.

Prototyping & Industrialization Support

• Monitor emerging technologies and equipment developments in the market.
• Develop and implement prototyping capabilities to support R&D and innovation projects.
• Ensure smooth transition from prototyping phases to full industrial production.

Job requirements

• Bachelors in Engineering (Mechanical, Industrial) or equivalent
• 6 -10 years of experience in Equipment and Process Engineering in the medical device industry
• Experience in equipment sourcing & qualification, commissioning and documentation
• Know how in process validation (IQ, OQ, PQ) and ISO 13485
• Excellent communication and stakeholder management skills