Sr. Engineer, Disposables R&D, NPD

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

Are you ready to take your engineering career to the next level? Look no further! Vantive is seeking a highly skilled Principal Engineer, Materials Scientist to join our exceptional Disposables R&D team in Plymouth. As a world-class leader in healthcare, Vantive is dedicated to improving the lives of millions of patients worldwide. This is a unique opportunity to be part of our ambitious mission and make a real impact.

The Sr. Engineer, Disposables R&D NPD will support new product development initiatives for disposable medical devices. 

What you will be doing:

• Support or lead projects, with global cross-functional teams, for the development of new disposable products or product extensions. 

• Develop user needs and translate them into product requirements. 

• Identify, investigate, and solve engineering problems utilizing risk-based and customer focused approaches and engineering tools. (e.g. dFMEA, Human Factors Engineering, statistical software, CAD). 

• Create, modify, and maintain design history file documentation including protocols, reports, design specifications, labeling, and design drawings. 

• Develop and execute test method validations, product testing, and verification / validation activities. 

• Build prototypes and models.  May operate machine tools, design and build basic tooling, test fixtures and assembly equipment. 

• Adhere to design control procedures, general safety rules, company policies and procedures, FDA and international regulations and guidance. 

What you will bring:

• BS in Mechanical, Plastics, Biomedical Engineering or a related field, MS preferred. 

• 3 - 5 years of related experience in Class II or Class III disposables medical product development. 

• Design for Six Sigma (DFSS) training or certification preferred. 

• Operating within a stage/gate based new product development process. 

• Working knowledge of plastics materials and processing such as injection molding, extrusion, ultrasonic welding, UV/solvent bonding, and sterilization.   

• Working knowledge of CAD and PDM enterprise software (e.g. Creo, Solidworks). 

• Working knowledge of FDA Design Controls and ISO 13485 Quality Management Systems.