Job Details

ID #45605626
State Minnesota
City Youngamerica
Job type Permanent
Salary USD TBD TBD
Source BAXTER
Showed 2022-09-11
Date 2022-09-01
Deadline 2022-10-31
Category Et cetera
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Principal Systems Engineer, Risk Management (Hybrid)

Minnesota, Youngamerica, 55573 Youngamerica USA

Vacancy expired!

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 Baxter

This is where your work saves lives

The 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 Team

While 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.

Qualifications
  • 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.

#LI-PL1

The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. EEO is the Law EEO is the law - Poster Supplement Pay Transparency Policy

Reasonable Accommodations

Baxter 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 Notice

Baxter 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. 076434

Vacancy expired!

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