Process and Industrialization Engineer (H/F) - CDI
Process and Industrialization Engineer (H/F) - CDI
Stilla Technologies is a Life sciences company whose mission is to improve health by offering researchers and clinicians worldwide solutions for high precision genetic analysis.
Since 2016, Stilla Technologies has empowered researchers with the naica® system, a solution that enables to detect & quantify nucleic acid with unprecedented precision.
The naica® system supports a wide range of genetic tests and molecular biology assays — including liquid biopsy tests for cancer diagnostics, viral load quantification, GMO detection, etc… Overall, the naica® system superior performances make it a preferred technology for precision medicine research and therapeutic monitoring.
Stilla® advises and supports its customers worldwide with a multidisciplinary team, whose expertise spans from microfluidics and chemistry to molecular biology and computer science. Stilla’s talented and multidisciplinary team shares a passion for building successful Life Science and Diagnostic products based on deep technological innovations.
The Process and Industrialization Engineer will integrate the Engineering and scale up group, within the Manufacturing & Operations department. He/she ensures the implementation of new production lines, leads improvement projects on current products and processes, and participate to the scaling up of production to support Stilla growth while maintaining the highest level of Quality and Productivity.
The Process and Industrialization Engineer main missions include:
Managing engineering projects & implement new production processes:
• Elaborate industrial product specifications based on R&D technical specs, marketing requirements, quality & regulatory requirements, logistics, etc.
• Transfer R&D protocols onto Production tools, and validate performance on prototypes or pilot batches
• Propose and implement smart engineering and technical solutions
• Drive the qualification and implementation of new methods, new production tools or quality control equipment
Managing the scale-up of existing production lines
• Participate to scale up plan elaboration in line with Stilla strategic plan
• Define process specifications based on product technical specs
• Evaluate and select partners, suppliers & integrators
• Develop automatized production lines following the scale up plan
Lead product improvement projects:
• Solve, with the support of R&D and Operations teams, the technical problems reported by Quality Control, Production or Customer Support. The scope includes all the components of the Naica system, and more specifically instruments, consumables, and their raw materials.
• Manage NC (non-conformities) and CAPA (corrective actions and preventive actions) in the Product Lifecycle Management software.
• Drive design and engineering change requests
• Lead problem solving task forces
Improve current production processes:
• Assess internal production processes performance (KPI)
• Propose and implement continuous improvement actions, such as:
o Redesign of parts
o New production protocols and processes
o New metrology and quality control instruments
• Propose optimizations of quality control protocols to improve cost-effectiveness while ensuring the maximum level of quality
• Lead the qualification of production tools and processes (ISO13485)
Work efficiently in a matrix organization
• Coordinate project activities with other team members, including R&D, Manufacturing, QC, Marketing/Sales and Quality Assurance resources
• Ensure an efficient communication and interaction between departments and smooth information transfer
• Manage the project using Agile methodology
• Share results through oral/written presentations, technical reports, production files, etc.
• Must have at least 5 years of experience
• Must speak French and English fluently
• Has an engineering degree / PhD / master 2 level, ideally in the medical device field, in Instrumentation, Automation, Mechanics, Mechatronics, Electronics or a related topic.
• Has one or more successful experiences taking part in the development or the industrialization of a medical device
• Has one or more successful experiences taking part in the scale up of production lines, ideally in the medical device field
• Has a good knowledge of quality & regulatory standards in the field, ex. ISO 13485, IVDD or IVDR
• Familiar with Production and Industrial environments, quick operational projects
• Passionate with Sciences and advanced technologies
• Capacity to manage suppliers and impact production teams
• Team spirit, with excellent communication skills
• Is pro-active, autonomous and rigorous
• Likes to interact with multiple teams and interfaces
• Ability to manage transversally
Why join us?
• Build amazing tools for Focused Genomics in a challenging environment
• Join a young and dynamic Life Science company
• Work with a team who shares a passion for building successful Life Science Products based on deep technological innovations.
Location: Villejuif (94 800)
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