Job Information
Medtronic Sr Systems Engineer in Mirandola, Italy
Careers that Change Lives
This is an exciting global position in clinical research that covers the field of extracorporeal blood purification (chronic therapies such as hemodialysis and acute therapies such as renal replacement therapies in the intensive care units). You will manage various aspects of clinical research activities including full management of clinical studies. You will work in close collaboration with our internal multi-functional team to provide clinical input and guidance.
The position will be opened during a phase where our operating unit move from Medtronic to a to-be-named company we are calling “NewCo”. NewCo will be an independent company with equal partners, Medtronic & DaVita. It will be established in calendar 2023 as a new company (NewCo) formed from Medtronic’s Renal Care Solutions Operating Unit focused on providing innovative technologies to support kidney care patients.
NewCo is uniquely poised to transform renal care and dialysis, building on Medtronic’s innovation and technology pipeline. The business will have the singular focus, financial commitment, deep domain expertise, and global footprint needed to accelerate the development and commercialization of affordable and scalable life-saving renal care technologies — particularly our transformative home dialysis platform technologies.
We offer you a position where you can work independently under limited supervision.
Main responsibilities:
Translate stakeholder need into product system requirements
Decompose product system requirements into product sub-system requirements
Perform requirements allocation, flow-down, traceability and interface definition studies
Support functional, risk and standards analysis
Collaborate with all other R&D teams and with other departments (Quality, Regulatory, Clinical, Marketing)
Plan task timeline and estimate effort
Must Have:
Master’s degree in biomedical engineering (or equivalent) and min. 2 years of relevant experience in design and development of active medical devices
or
Bachelor’s degree in biomedical engineering (or equivalent) and min. 4 years of relevant experience in design and development of active medical devices
Fluent in Italian
English - intermediate level
Nice to Have:
Knowledge of dialysis therapies and devices
Knowledge of medical standards and regulations (ex. 13485, 14971, 60601-1, 60601-2-16, MDD/MDR)
Experience in internal and external audit (TUV, FDA, NMPA, ANVISA)
Experience or certification in Requirements Engineering
Skill in using Requirements Engineering SW tools
Additional Info:
Site: Mirandola (MO) – Italy
Hybrid work (home based/office based)
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.
Physical Job Requirements
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.