Vantive: A New Company Built On Our LegacyBaxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. 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 are driven to help improve patients' lives worldwide. Join us as we revolutionize kidney care and other vital organ support.*Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.SummaryThe Renal Human Factor team is a part of the R&D organization that supports the Renal business Within the team we provide Human Factor activities in all product phases, innovation initiatives, new product development and improvement programs for existing therapy systems. This collaborative role gives you the direct opportunity to define solutions to new products and services to patients and continue Baxter's mission to save and sustain lives.In this role as a Human Factor Principal Engineer, you will directly influence the usability and the patients/user's perception of the Baxter products. In this role you will apply human factor engineering principles to the design, development, and evaluation of medical products while working with cross-functional program teams.What you'll be doingLead human factors engineering work and research for medical devices and regulated healthcare productsPerforming human factors/usability studies (formative and summative) for hardware, software, labeling, and disposable productsDesign and execute usability evaluations to secure safe and easy product useLead the development of a Use-Related Risk Analysis, as part of the risk file for the productsDeveloping and communicating Human Factors project scope, plans, tasks and deliverables with program teams; managing time to meet project deadlines. This includes reporting pertinent information at key milestones through clear, concise oral and written communicationIn partnership with other R&D teams, developing product prototypes for user interface evaluation and validationWith minimal direction, responsible for directing and coordinating all human factors activities necessary to complete a major product development program or several small projectsLeading efforts to develop processes and procedures that align to Baxter initiatives and FDA/international human factors standardsProviding technical supervision to less experienced human factors engineers and may be responsible for the management of a small work groupPresenting and advising on human factors topics across the organizationWhat you'll bringProven experience in HFE principles and methodologies (ergonomics, usability evaluations, data collection, data analysis, etc.). Proven experience in applying human factors techniques on programs across product lifecycle (user research, prototyping, formative & summative product evaluation, use-related risk analysis, etc.). Demonstrated working knowledge of IEC 60601-1-6, IEC 62366, and FDA HF/Usability Guidance Document and experience working in regulated industryStrong interpersonal and communication skills in written and verbal form Demonstrated ability to provide technical leadership for HFE projects with substantial complexity and scope. Education and Work Experience:Masters degree in Engineering or equivalent7+ years of human factors relevant experienceExperience in medical device industry preferred#LI-CG1Reasonable AccommodationsBaxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.Recruitment Fraud NoticeBaxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.SummaryLocation: Medolla, ModenaType: Full time
