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

Process Design / Equipment Engineer