Systems Engineer, Principal

3 weeks ago

Brockton, Massachusetts, United States Baxter Full time

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.

Your Role:

You will be responsible for supporting the overall technical direction and work for novel Acute Therapies products. Based on your technical skills, you will drive various portions of the product development cycle at stages ranging from feasibility through lifecycle management. You will review and approve design concepts/changes and provide general direction to technical staff, including ensuring that quality is built into the design during new product development and/or sustaining activities. Proactively supervising the program and developing strategies to mitigate technical risks is expected as well as reporting on the progress to senior management during routine cadence meetings.

What You'll Be Doing:

  • Perform the activities associated with the Systems Engineering of one or more products in different stages of the product lifecycle from new product development to post-market surveillance
  • Understand clinical and user needs and apply them to product realization
  • Capture inputs for Requirements from various sources such as Standards, User needs, Regulatory, Quality, Human factors, Manufacturing, Service, etc.
  • Use knowledge of technology, process, and/or therapy domains to drive solutions and product design realization from a Systems perspective
  • Initiate, develop, and lead feasibility by crafting design concepts and research methodologies that best meet both current and future customer / business needs for a product or process domain area
  • Build and maintain Design History File elements and ensure traceability to requirements
  • Facilitate an improved understanding of the interrelationship between Requirements, Risk and Reliability
  • Anticipate technical challenges and risk scenarios and then prepare, lead, and execute mitigation strategies to ensure safe and effective results
  • Resolve systems-related technical issues by applying problem-solving tools such as cause and effect diagrams, Pareto charts, etc.
  • Propose and drive solutions to technical problems that are ambiguous and diverse in scope
  • Perform impact assessments on the Requirements on an ongoing basis for any proposed design/material/process change or an observation in the field/service or manufacturing to determine the impact and need for any mitigations, then propose recommended mitigations with the rationale
  • Influence partners and multi-functional team members within the project
  • Drive consistency to FDA, ISO and IEC design control procedures, regulations and standards
  • Use various software tools and programs (e.g. DOORS) to complete the above responsibilities
  • Teach and mentor others in life cycle management methodologies

What You Need:

  • A Bachelor's degree in Electrical, Mechanical, Biomedical, Controls, Systems, Software or other related technical/engineering field
  • 8+ years of industry work experience
  • Must possess sound knowledge of systems engineering and related areas such as electro-mechanical and software engineering
  • A demonstrated track record in electromechanical system development, preferably medical devices or other highly regulated products such as military hardware
  • Demonstrated strong analytical and problem-solving skills
  • Success in working with multi-functional, global teams
  • Excellent interpersonal/communication/influencing skills

Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $104,000.00 to $143,000.00 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.

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.

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