Senior Process Development Engineer

Job Description:

POSITION SUMMARY

We are seeking an experienced engineer to develop and industrialize robust manufacturing processes for TransMedics’ innovative disposable medical device systems that support life-saving organ transplant technologies. This role partners closely with R&D, Advanced Manufacturing, and key stakeholders to ensure seamless transition from concept and prototyping through scalable production, ensuring process reliability and product quality. This individual will play a critical role in advancing breakthrough technologies that improve patient outcomes worldwide through technical rigor, innovation, and operational excellence.

RESPONSIBILITIES

This position is responsible for, but not limited to, the following:

• 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.

• Perform other TransMedics tasks and duties as assigned/required.                                      

MANAGEMENT RESPONSIBILITIES

• This position will not have management responsibilities.

PHYSICAL ATTRIBUTES 

• No Physical attributes                                                                                                         

MINIMUM QUALIFICATIONS

• Broad technical experience in biomedical device environment, manufacturing processes and equipment of disposables, polymeric, testing and characterization methods, measurement systems;

• 7+ years of experience in medical devices;

• Degree in mechanical / mechatronic / biomedical / physics engineering or equivalent;

• Deep knowledge of statistics;

• Ability to bring disruptive medical technologies from concept to commercialization

• Knowledge of statistics

• 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

• Excellent communication skills in English; Italian language skills preferred

• Good knowledge of Microsoft Office suite;

• Willingness to relocate to Mirandola, Italy

Every Organ Wasted is a Life Not Saved.