Principal R&D System Engineer (dialysis machine)

Principal R&D System Engineer BELLCO, now part of Medtronic in the Renal Care business, is a company, based in Mirandola (Modena – ITALY), leader in systems for hemodialysis and extracorporeal blood purification. Our therapies and systems are employed for the treatment of renal failure, multiple organ failure, sepsis and cardiac decompensation. We are focused on satisfying the needs of patients and experts through: Innovation, Research, Development of advanced Nephrology, Intensive Care and Cardiology Therapies. Position Description: This engineering position requires strong technical skills and an ability to support and lead the design and development of innovative, new products within the Renal Care Solutions business. The position is based in Mirandola, Italy. Position Responsibilities: • Be creative and apply solid mechanical engineering design skills while following design controls to develop new medical devices • Develop concepts and build prototypes for marketing, user feedback, technical feasibility of device functionality, design for manufacturing and design for assembly • Contribute as the R&D team member to complete various project activities – development of design inputs from user needs, generate concepts, evaluate feasibility, generate FMEAs, assist with risk analysis, and perform design verification and validation, assist in design transfer and setting up manufacturing processes • Create and implement the product test plans/protocols and generate test reports to ensure product design meets the specifications and quality system requirements • Make, recommend or justify critical technical decisions based on scientific investigation and testing in product design and ensure their implementation in development • Work closely with cross-functional team, including design reviews with various engineering disciplines to ensure the design meets the product requirements, including safety, reliability and manufacturability • Be creative in finding cost effective and innovative solutions in the product development process • Work closely with supply chain, contract manufacturers, vendors and suppliers to ensure quality goals are met • Familiarity with medical device regulatory environment including FDA regulations and guidance such as QSR, GMP, Usability • Able to work in global collaborating environment with intensive challenges • About 30% travel involved. Basic Qualifications: • Required – BS in Mechanical Engineering, Biomedical Engineering or similar with 7+ years of design and development • Preferred – MS or PhD in Mechanical Engineering, Biomedical Engineering or similar with 4+ years of design and development experience. Skills required: • Demonstrated capability for designing and developing a medical device or component, or manufacturing process with focus on fluid mechanics • Demonstrated ability to develop models, engineering drawings and familiarity with GD&T using CAD software • Demonstrated strength in building strong relationships at all levels of the organization, cross functionally, and with key people external to the organization. • Excellent documentation skills • Excellent communication skills Location: Mirandola (MO) - ITALY About Medtronic Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives.Help us shape the future. Whatever your specialty or ambitions, you can make a difference at Medtronic - both in the lives of others and your career. Join us in our commitment to take healthcare Further, Together. At Medtronic, you will find a diverse team of innovators who bring their unique backgrounds and their individual life experiences to work every day. We work hard to cultivate a workforce that reflects our patients and partners, we believe it’s the only way to drive healthcare forward. We want to attract a diverse workforce, regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, veteran status, or any other characteristic protected by state or local law. Join us and bring the power of your point of view to our culture of collaboration and innovation. It is through strong diversity, inclusion and engagement that we can remain a leader in medical technology and solutions. And by embracing everything you have to offer — your unique perspectives, talents and contributions — we can live up to the promise of our Mission. Additional Information Posting Date: Dec 9, 2020 Travel: Yes, < 25 % of the Time ...