Systems Engineer, Product Design Owner (Hybrid) Job at BAXTER

BAXTER Skaneateles Falls, NY

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 Product Design Owner 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.

We courage teamwork and collaboration and prioritize building relationships with each other. It's easy to do because we all share common traits of reliability, ethical, and caring. We lean on our colleagues for their expertise and hold each other accountable.

What you'll be doing:

As the Systems Engineer, Product Design Owner you will be responsible for the management of the design of the Baxter Front Line Care Patient Monitoring products throughout the on-market product lifecycle.

  • Responsible for providing the technical assessment inputs & associated risks in enabling the business priority decision for the product and/or design change along with commercial and program inputs.
  • Has authority and accountability to maintain and/or update the product design.
  • Ensures compliance, quality and continuity of products in the market.
  • Ensures consideration of guidance from external/internal stakeholders.
  • Works on the technical challenges and risk scenarios and prepares, leads & drives mitigations to ensure optimal results in conjunction with the Sustaining Engineering organization.
  • Assures design reviews and technical reviews are conducted as required by the quality system.
  • Approves, controls and owns Design History File (DHF) elements, product and process changes, including leading the Risk Management Assessment in conjunction with the Product Risk Management Owner.
  • Responsible to drive continuous adherence to FDA, ISO, and IEC design control procedures, regulations and standards.
  • Use current product knowledge to facilitate change control when required for product support post marked such as SNC, SCAR, complaint investigation or updates to the DHF and Technical documentation.

What you'll bring:

  • Bachelors in disciplines such as Computer Science, Mechanical, Electrical, Biomedical Engineering or other relevant degrees with 5+ years of experience.
  • 5+ years’ experience in product lifecycle management (sustaining) or other relevant product development experience in a regulated industry.
  • Knowledgeable in Product Design and Development and Quality System, Lifecycle Management Processes, the intended and actual use of the products, and has technical expertise associated with assigned product and/or domain.
  • Demonstrated application of knowledge in HW, SW and System engineering.
  • Have the knowledge of the regulatory environment for design, development and manufacturing.
  • Knowledge of manufacturing practices and improvements (yield improvements, etc.) sufficient to be able to assess changes, incremental risks.
  • Actively facilitates and negotiates to drive the closure on product/program-related decisions/issues.
  • Good verbal and written communication skills.
  • Ability to work collaboratively as part of a global, cross functional team and consults/takes the guidance to manage independently.
  • Familiarity with IEC, ISO, FDA and other regulatory standards and GMP/QSR environment preferred.

Hybrid work schedule coming in the office 2 or 3 days a week.

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 our employees, and we strive to be more transparent with our pay practices. To that end, this position has a base salary range of $68,000 to $156,000, plus an annual incentive bonus. The above range represents the expected base salary range for this position. The actual salary may vary based upon several factors including, but not limited to, relevant skills/experience, time in the role, business line, and geographic/office location.

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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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