Job description

This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride. Your role at Baxter The Principal Systems Engineer will serve as a Product Design Owner (PDO) responsible for technical owner for the design, risk and integration of infusion pump systems and/or projects, which combine electro-mechanical hardware, embedded software, and user interface components, as well as the interface with other related EM and/or digital products. This role drives operational excellence and predictable, consistent execution in our products, and design and risk integrity and may serve as Risk Owner on some projects. The engineer is accountable for product safety, performance, reliability, usability and regulatory compliance, as well as risk. The PDO drives design decisions, manages design control activities, may be accountable for a product risk file, and collaborates across engineering disciplines and cross-functions to deliver robust, reliable, safe and innovative infusion therapy solutions. What you will be doing: Leads interdisciplinary design and development of medical products in compliance with FDA, EU MDR, ISO 13485 and other global regulatory standards to enhance patient outcomes. Accountable for end-to-end system traceability completeness. Has final technical decision authority, leads trade-off analysis and makes critical decisions. Ensures technical risks are anticipated and identified, mitigations implemented and aligned with product objectives at all stages of a project. Works in collaboration with Product Risk Owner and may serve as Risk Owner. Accountable for and drives overall product requirements, architecture, interfaces and product design realization, ensuring inclusion of inputs from all stakeholders. Understands and resolves competing constraints while driving collaboration of the technical team as well as cross-functionally (engineering, manufacturing, regulatory, clinical, commercial, etc) throughout the product lifecycle. Accountable for content and robustness of design reviews and program design changes, and compliance with PDLM processes and procedures, including DHF documentation and audit and regulatory submissions technical preparation. Fosters a creative, collaborative and innovative environment including focus on innovation and continuous improvement. What you will bring: Must have good working knowledge of regulations and standards affecting medical devices and have experience with products under design control Bachelor’s degree in engineering (Mechanical, Electrical, Software, or similar) with 5 years of experience. Has led the transfer of at least one project. Preferred: Minimum of 5 years of relevant experience in medical device manufacturing industry. Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a required minimum number of days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission. The flexible workplace policy is subject to local laws and legal requirements. At its discretion, Baxter may decide to adjust, suspend, or discontinue as business needs change. 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 $112,000 to $154,000 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. This position may also be eligible for discretionary bonuses. 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. Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time. #LI-OM1 US Benefits at Baxter (except for Puerto Rico) This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter 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. Know Your Rights: Workplace Discrimination is Illegal 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 .

Requirements

Must-haves

This is where your work makes a difference.
Here, you will find more than just a job—you will find purpose and pride.
Your role at Baxter
Accountable for and drives overall product requirements, architecture, interfaces and product design realization, ensuring inclusion of inputs from all stakeholders.
Fosters a creative, collaborative and innovative environment including focus on innovation and continuous improvement.
Must have good working knowledge of regulations and standards affecting medical devices and have experience with products under design control
Bachelor’s degree in engineering (Mechanical, Electrical, Software, or similar) with 5 years of experience.
Has led the transfer of at least one project.
Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.
US Benefits at Baxter (except for Puerto Rico)

Nice-to-haves

Preferred: Minimum of 5 years of relevant experience in medical device manufacturing industry.

Application prep

Use the role’s language and application details while tailoring your materials.

Platform: workday
Effort: long

Benefits

Benefits detected in the listing.

Dental

401(K)

Paid Time Off

Parental Leave