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
