Senior Process Development Engineer

Location: Mirandola

Process development
Responsible for the development of manufacturing processes involved in New Product Development of disposable systems, sharing the vision with the VP of Disposables Development and the main stakeholders.
Ensure Robust Design of TMDX Disposables devices creating Robust manufacturing processes, taking part to design, prototyping and testing activities and being responsible for an extremely accurate and detailed analysis based on an initial limited number of data obtained from the prototyping phase, finally moving to the transfer of design to Manufacturing.
Work intensively with R&D members (e.g. mechanical, prototyping and test engineers) and Advanced Manufacturing engineers, applying technical and engineering skills to ensure design for manufacturability.
Define technical specifications aimed to the realization of equipment for prototyping, testing and manufacturing, in cooperation with internal stakeholders and external suppliers.
Define test methods and protocols for the characterization of the technical features and the CTQ.
Transform the prototyping phases into physical / technical parameters leading to the definition of manufacturing processes and production recipes.
Apply the expertise developed in devices manufacturing to investigate physical failures through reverse engineering, autopsies of devices, measurements and inspections using either destructive or nondestructive methods.

Knowledge, skills and abilities required
Broad technical experience in biomedical device environment, manufacturing processes and equipment of disposables, polymeric, testing and characterization methods, measurement systems;
At least 7 years of experience in medical devices;
Degree in mechanical / mechatronic / biomedical / physics engineering or high school diploma in technical field associated to extended experience in the same role;
Deep knowledge of statistics;
Ability to bring disruptive medical technologies from concept to commercialization
Proven track record leading technical teams to successful product launches
Ability to work in an international environment
Highly motivated to enhance products, techniques and consequently the life of the patients
Willingness to relocate to Mirandola, Italy