Responsibilities

Transition from the R&D processes to GMP-compliant production (class 3, medical implantable devices).
You will be responsible for internal manufacturing processes/manufacturing technology, as well as key sub-contracted manufacturing processes in collaboration with suppliers.
The function includes responsibility for the technical manufacturing infrastructure, tooling-technology definition, qualification of equipment, process validation and process capability, technical documentation, process-monitoring, production-scalability strategies and user training, management/maintenance of internal equipment.

• Provide and contribute to manufacturing requirements within the scope of and from product design to ensure technological partners and solutions meet project requirements.
• Improve the manufacturing processes; new equipments design, processes, and manufacturing procedures
• Create installation, maintenance, and servicing procedures and methods
• Establish production process specifications, including the appropriate equipment specifications, production methods, production procedures, and production environment specifications
• Implement and execute procedures, methods and plans for: process (re-)validation, process monitoring, process stability and -capability.
• Coordinate and realize equipment and related infrastructure purchasing, installation and qualification per applicable GMP requirements
• Implement procedures and methods to provide for adequate equipment availability and -reliability (continuity and capacity)
• Key actor in building and maintaining the DMR (Device Master Record-ref. FDA 21CFR820.40), in alignment with the process responsible actors for the DHF (Sr. Mgr. R&D) and the DHR (Mgr. Production & Quality)
• Key actor in building and maintaining the VMP (Validation Master Plan), in alignment with the process validation responsible actor for the equipment qualification and process validation (Production, R&D and Quality departments)
• Risk analysis and risk management of manufacturing processes (internal and external in cooperation with suppliers),
• Participate in the referencing, qualification and periodic evaluation of suppliers and sub-contractor

Qualifications

• Proven track-record of at least 5 years’ experience, in a similar role in the medical device industry or in a comparable highly regulated industry.
• University degree in Engineering (Mechanical, Industrial design, Physics, Automation, or similar)
• English fluency, with openness to lean Italian