- Lead human factors engineering work and research for medical devices and regulated healthcare products
- Performing human factors/usability studies (formative and summative) for hardware, software, labeling, and disposable products
- Design and execute usability evaluations to secure safe and easy product use
- Lead the development of a Use-Related Risk Analysis, as part of the risk file for the products
- Developing 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 communication
- In partnership with other R&D teams, developing product prototypes for user interface evaluation and validation
- With minimal direction, responsible for directing and coordinating all human factors activities necessary to complete a major product development program or several small projects
- Leading efforts to develop processes and procedures that align to Baxter initiatives and FDA/international human factors standards
- Providing technical supervision to less experienced human factors engineers and may be responsible for the management of a small work group
- Presenting and advising on human factors topics across the organization
- Proven experience in HFE principles and methodologies (ergonomics, usability evaluations, data collection, data analysis, etc.).
- Demonstrated working knowledge of IEC , IEC 62366, and FDA HF/Usability Guidance Document and experience working in regulated industry
- Strong interpersonal and communication skills in written and verbal form
- Demonstrated ability to provide technical leadership for HFE projects with substantial complexity and scope.
- Masters degree in Engineering or equivalent
- 7+ years of human factors relevant experience
- Experience in medical device industry preferred
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R&D Human Factor Principal Engineer - Medolla, Italia - Baxter
Descrizione
Vantive: A New Company Built On Our Legacy
Baxter 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.
Summary
The 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.
What you'll be doing
What you'll bring
Education and Work Experience:
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