POSITION SUMMURY:

　　The purpose of the Design Engineer is to provide expertise for tools, equipment and processes changes, with specific focus on Equipment Development. In addiction Design Engineer has to give support for new product development or product changes. He/ she has to guarantee technological and scientific knowledge used during the products and components manufacturing and control (material, products and processes). Design Engineer is also involved in the validation and risk assessment evaluation of the changes.

　　ESSENTIAL JOB FUNCTIONS:

　　Guarantee technological and scientific knowledge on mechanical design, to be used in the Quality Control or Manufacturing areas; this task will be achieved through a correct update of state of the art technologies by means of contacts in the scientific environment, such as Universities, Research Centers and Consultants

　　Ensure technological and scientific knowledge on mechanical design, to be used during new product, prototype or process development in collaboration with R&D

　　Guarantee manufacturing process development of Heart Valves new products, with specific focus on automated/software process and Equipment Development: this task will be achieved through a preliminary process/products analysis definition followed by a preliminary Risk Analysis evaluation and a process/product verification, complying specifications and international regulations

　　Ensure Heart Valves Components process and product qualification, and design transfer to Manufacturing: by use of internal procedure and methods and meeting international standards. He/she is responsible for the position to perform the proper product/process transfer to manufacturing. The transfer will be operated involving all functions needed: this position must guarantee the correct involvement of all functions and a support documentation editing (i.e. Protocols definition, Risk Analysis editing, Change Request open, support to Validations and Reports finalization, Technical Specification editing), according to the internal QMS

　　Provide technical support for identification and qualification of external suppliers

　　Provide technical support and proper technical information to transfer to Manufacturing Value Stream Groups and R&D

　　Support and collaborate with tool shop to ensure the proper production of tools and prototypes

　　Ensure the state of validation of the processes necessary for the manufacturing and quality control of products of the HV Industrial Area, with particular focus to Nitinol and THV areas

　　KNOWLEDGE, SKILLS AND ABILITIES REQUIRED:

　　The following knowledges and skills are necessaries:

　　CAD 3D deep knowledge is mandatory (PTC CREO)

　　Good knowledge of design and development of mechanical applications

　　Good knowledge of validation techniques/methods (Test Plan, Test Report, FMEA)

　　Good English knowledge

　　Attitude to teamwork

　　Written and spoken reporting competences

　　Machining processes (turning, milling) knowledge

　　Software experience (Office suite)

　　Driving license

　　EDUCATION:

　　University Degree in Engineering.

　　EXPERIENCE:

　　At least 2 years of experience in design team in medical device or pharma industry.