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. 

What you will be doing

Provide Quality Engineering leadership for software and hardware product development teams. Responsible for leading design control, risk management, and other Quality Engineering activities for new product development projects.Establish and nurture strong relationships with cross-functional product development team members to optimize success of development projects.Lead the development and maintenance of the Risk Management File (RMF) including risk management plans, hazards analysis, dFMEAs, pFMEAs, and risk management report.Provide Quality Engineering input, review, and approval of the Design History File (DHF) and associated documentation. Responsible for quality oversight and approval of product development plans, design inputs and outputs, verification and validation, and review of test planning, protocols, and reports. Provide guidance on statistical methods and analyses for design verification and validation, including test method validation.Serve as the SME for software quality and collaborate with teams on code reviews, software security analysis, and the software BOM; lead implementation of best practices for software quality processes.Participate in design reviews to ensure the effective development, transfer, and maintenance of the product (hardware and software) throughout the product lifecycle.Support the successful transfer and hyper-care phase of design and design modifications into production / field deployment.  Secondary/Backup Duties and Responsibilities:Lead changes to the Quality System based on new regulations, guidance documents, industry standards, and observations.Own the resolution and timely closure of CAPAs as they relate to the design control process.Support other areas of the Quality System and perform other tasks as defined by Management

What you will bring

8+ years of progressive Software Engineering experience in the medical device industryB.S./M.S. in relevant engineering field (e.g., biomedical, software, electrical, etc.) or equivalent scientific degree.Experience with the application and implementation of FDA CFR 820, ISO 13485, ISO 14971, IEC 60601 series, IEC 62304, and IEC 62366. Experience in the design, development, verification, validation, and test activities for medical device hardware and software, including electromechanical medical devices and both embedded and non-embedded software.Experience in the deployment of quality engineering tools for design and process improvement; extensive knowledge of statistical tools and data analysis techniques.Exceptional attention to detail with the proven ability to wear many hats.Must be comfortable working in a high-growth company with rapidly evolving needs, responsibilities, and expectations.Creative problem solver.Proficient in statistical analysis (e.g., Minitab), and other business software.Certified ASQ CQE, and/or Six Sigma Black Belt/Green Belt preferred.Experience with artificial intelligence, working within an AAMI TIR45 framework, and SaMD is preferred.Experience supporting development of classic and artificial intelligence (AI) software algorithms and deep understanding of cloud infrastructure is preferred.

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 $136,000 to $187,000 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.

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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)

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

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