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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 Sr. 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:As the Sr. Engineer at Baxter, you will provide technical support in Risk Management activities for Device Engineering. Drive standardized execution of Risk Management process that is effective, efficient, and compliant with Baxter processes and Regulatory Standards. We offer relocation benefits and a hybrid work schedule.What you will be doing:- Responsible for supporting the activities associated with the Risk Management of products in various stages of the product lifecycle from new product development to post-market surveillance.
- Provides ongoing risk analysis and identification of required risk mitigations to ensure a safe, effective product.
- Responsible for identifying risks and helping define requirements and verification & validation testing to mitigate risk
- Drive completion of Risk Management activities towards design transfer and successful commercialization of new products.
- Provides subject matter expertise to product development teams to ensure Risk Management principles are applied throughout the development cycle.
- Creator and an approver of Design History File deliverables associated with Risk Management.
- Coordinate interrelated Risk Management activities across functions.
- Participate in identifying and planning tasks, activities, and resourcing needs related to Risk Management.
- Collaborates with Engineering, Manufacturing, Software, Human Factors, Clinical/Medical, and Service organizations in the development of design FMEA, Process FMEAs, and roll-up into Risk Management files. Working knowledge of FMEAs and standards applicable to Reliability Engineering (e.g. IEC 60812).
- Able to analyze risk/tradeoffs and make recommendations of the appropriate path forward.
- BS degree in Engineering, with approximately 3+ years experience or Masters with 1+ years.
- 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.).
- Prefer: A good working knowledge of regulations and standards affecting a regulated industry and have experience with products under design controls, documentation controls, risk management, and validation.
- Excellent English verbal and written communication skills. Clear and effective communication (written and oral) and presentation skills.
- Self-directed, resourceful, and able to work on multiple projects and priorities.
- Analytical, detail-oriented, thorough, and accurate. Open to accepting critiques and striving for continuous improvement in every task.
- Able to work in a fast-paced environment.
Vacancy caducado!