Production & Site Operations Manager (m/f/d)

Production & Site Operations Manager (m/f/d) 📍 Lausanne | 60% (Tuesday to Thursday) | Start: as soon as possible Who we are SmartCanula is a fast-growing Swiss medical device company headquartered in Lausanne, with operations in Frankfurt. We develop the smartcanula for cardiac surgery, CE-marked and in active clinical use across 40+ countries. Our cannulas are produced in our own cleanroom in Lausanne and used by surgical teams in hospitals worldwide. We move fast, decide quickly, and take ownership seriously. We build our own paths. If that is how you work, you will fit right in with our small team. The role You own our Lausanne site. As the technical person who keeps production and the cleanroom running. You work hands-on in the cleanroom, following strict quality standards. You make sure every cannula leaves the site on time and fully traceable. You keep premises, equipment and deliveries under control. You are our key person on site and the direct link to the operations team in Frankfurt. Specifically, you will:
• Run and supervise our semi-automated production processes and quality controls in the cleanroom, in line with our ISO 13485 quality system
• Monitor production processes and quality controls, and find ways to make them more efficient and robust
• Solve production and equipment problems quickly to keep downtime low
• Organize sterilization cycles: prepare batches, manage transport to and from the sterilization provider, and keep traceability and sterilization records complete
• Prepare and ship customer orders
• Receive incoming materials and equipment, check conformity, and register and store them correctly
• Follow up on supplier orders and deliveries
• Take care of first-level maintenance of premises and equipment, and coordinate external service providers
• Make sure the site meets all regulatory and quality requirements and is always audit-ready
• Report directly to the Supply Chain Manager and work closely with the team in Frankfurt What success looks like in year one: Production and customer shipments run on schedule, with no delays caused by the site. Sterilization cycles and records are complete and audit-ready. The site runs smoothly, also on the days you are not there. What we're looking for Background: Technical training or a degree in a relevant field, such as medical technology, process engineering, chemistry, mechanical engineering or production technology. A Swiss vocational qualification (CFC/EFZ) in a technical field is very welcome.

Experience:
2+ years in production, a laboratory or a cleanroom, ideally in medical devices or another regulated environment (ISO 13485). Hands-on: You enjoy practical technical work. You set things up, fix things, and find solutions that work in daily practice. The cleanroom is your workplace, not a place you visit. Precision: You work carefully and document what you do in a regulated environment. Ownership: You work independently, set your own priorities, and act when something needs to be done. No one needs to remind you what to do next. On top of that:
• Fluent in English and French (both required)
• German is a plus
• Available on site in Lausanne on Tuesday, Wednesday and Thursday
• Swiss or EU/EFTA citizenship, or a valid Swiss work permit. Cross-border commuters (G permit) are welcome.
• Experience in QMS documentation or production scale-up is an advantage

What we offer
• A key technical role with real responsibility from day one
• Fixed 60% schedule (Tuesday to Thursday)
• A small international team with short decision paths
• Direct impact on a product used in cardiac surgery worldwide Make it yours Do you want to take responsibility in ensuring smooth operations of a manufacturing site in Medtech? Then reach out directly. No long process. Tell us who you are, what you have worked on, and why this role is yours.