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This is where you save and sustain lives
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work. Join us at the intersection of saving and sustaining lives- where your purpose accelerates our mission. Your Role at BaxterThis is where your work saves livesThe research we do and the products we develop improve outcomes for patients around the world. As a Principal Engineer at Baxter, your work contributes directly to making a significant impact on others. It's challenging work-and you're not on your own. Our teams collaborate cross-functionally and lead by influence. Whether guiding a team through a project or managing direct reports, our research and development team is responsible for influencing others to achieve results.Our colleagues within our R&D organization desire to work on products that make a meaningful difference in others' lives. We are motivated by the power of teamwork and are natural leaders who are skilled at influencing others.Your TeamWhile everyone at Baxter has a shared passion for our mission, the R&D teams play a critical role in our ability to save and sustain lives. Scientists and engineers in R&D work together to develop, test, and launch products that enhance patient care.Your role at Baxter:This rapidly growing team works on new product development and sustainment of the current PrismaFlex and Prismax product lines and related consumable sets within our Acute Therapies business unit. AS the Principal Engineer, you will work with multiple engineering disciplines, product development support staff and users using Systems Engineering principles. You will also contribute to both new product development and help in sustaining the current business product lines. We offer relocation benefits and a hybrid work schedule.What you will be doing?- Guide and assist System Lead Engineers with feasibility studies and formal documentation.
- Serve as product risk management owner for one or more products.
- Lead creation of user need requirements and decomposition of those requirements to System and Subsystem requirements.
- Collaborate cross functional with multiple disciplines to identify new, obsoleted or adjusted regulatory standards (e.g. FDA or IEC).
- Review and approve System and Subsystem requirement documents to ensure user needs are properly decomposed and intent of the user needs is met.
- Collaborate with Human Factors Lead in conducting formative and summative testing.
- Identify and work with Systems Risk management specialist to identify risks and help define characterization, verification and human factors testing to mitigate risk.
- Create and assist System Validation Lead in generation of validation test cases and execution of plans to generate reports to verify user needs have been met.
- Assist sustaining teams from quality, development, manufacturing and field support in investigation of field and manufacturing issues. Attend and engage in CAPA and NCR activities as needed.
- Work to identify process improvement and implement process improvement changes.
- B.S. in Engineering, Biomedical Sciences, and Biomedical Engineering, or equivalent degree and 5+ years of relevant experience or Masters with 3+ years.
- Experience in relevant electromechanical disciplines and design.
- Experience in Product Design, and familiar in full life-cycle product development methods/activities.
- Understanding and application of the standards related to Risk Management and Reliability: (e.g., ISO 13485, ISO 14971, IEC 60812, IEC 61025, IEC 62366, IEC 60601, IEEE-1633, etc.).
- Experience in creation of typical failure analysis deliverables (Hazards Analysis, FMEAs, FTAs, etc.).
- Experience with plastic consumable design and development a plus.
Vacancy caducado!