Our client, a Milan-based pioneering MedTech startup specializing in the development of percutaneous solution in the structural heart field (class III medical device), is looking for a **Manufacturing and Operations Manager** The Manufacturing and Operations Manager will progressively take ownership of manufacturing and operations activities, in preparation for pilot and subsequent pivotal clinical studies.. This is a hands-on role in a fast-growing startup environment, with strong exposure to suppliers, technical teams and quality/regulatory functions. **Key responsibilities**
- Own end-to-end manufacturing and operations activities, including production planning, supplier coordination and issue resolution
- Manage and coordinate external contract manufacturers and suppliers, acting as the main operational interface
- Support manufacturing process control and validation, in collaboration with Technical, Quality and Regulatory teams
- Ensure manufacturing documentation and activities are compliant with the company QMS and regulatory requirements
- Lead day-to-day operational activities supporting pre-clinical and clinical supply




- Manage and mentor one team member involved in manufacturing operations
- Contribute manufacturing process scale-up with the evaluation of future internal manufacturing capabilities, including clean room facility **Requirements**: - Master’s degree in Engineering or relevant technical field
- 5+ years of experience in medical device manufacturing, preferably Class III devices
- Experience managing external manufacturers and suppliers
- Solid understanding of manufacturing processes, validation and quality systems (ISO 13485, ISO 14971)
- Hands-on, operational mindset, comfortable working in a startup environment
- Fluent English
- Willingness to travel frequently to manufacturing partners in Northern Italy, with occasional international travel **Location & flexibility**
- Based in Milan.
- Some remote working flexibility, with regular on-site presence and frequent supplier visits Contratto di lavoro: Tempo completo, Tempo indeterminato Retribuzione: €60.000,00 - €75.000,00 all'anno

📌 Manufacturing and Operations Manager (Milano)
🏢 Amygdal
📍 Milano