Principal Quality Engineer

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

The Principal Quality Engineer will work as a member of one or more project teams by being engaged in sustaining products and/or new product development for medical device systems within Medication Delivery with a focus on infusion pumps. Provides Quality Engineering support to product development programs and projects. This individual will work closely with product engineering to ensure robust requirements, successful design, development, verification and validation testing, design transfer, change control management and will also provide support to medical product sustaining engineering.

What you will be doing:

• Provide Quality Engineering support for software and hardware product development teams, responsible for leading design control, risk management, and quality engineering activities.

• Participate in the development and maintenance of the Risk Management File (RMF) including risk management plans, hazards analysis, dFMEAs/pFMEAs, and the risk management report.

• Ensure compliance to applicable Baxter policy, procedures, and regulations

• Provide direction and critical reviews for Development Planning, Design Inputs, Design verification and Validation, Peer Technical and Design Reviews, Risk Management and Labeling review

• Collaborate with Baxter plant, external partners, and corporate groups to transfer new and improved products

• Develop, review, and approve DHF, DMR, risk management, verification, validation, and other product development documents

• Develop and revise procedures to support product development programs and projects

• Complete design and technical tasks, integrating information from a variety of teams.

• Lead corrective and preventive action related activities as appropriate

• Incorporate knowledge of customer use and product design to predict product effectiveness/anticipate potential failures.

• Excellent problem-solving skills

• Identify and resolve issues that may jeopardize project schedules or improve project time.

• Supports Quality internal and external audits as required.

• Perform other duties as assigned

What you will bring:

• Bachelor’s degree in engineering required, MS is preferred, 8 years relevant experience.

• Relevant experience supporting products in a regulated environment is required.At least 3 years of Quality Engineering experience is required

• Experience with electromechanical devices is required

• ASQ and/or Six Sigma certification preferred

• Experience working in Agile product development environment desired

• Knowledge of the global Regulatory and Quality requirements for medical devices including ISO 13485, FDA Quality Systems Regulation, ISO 14971, MDD 93/42/EEC, EU MDR and other applicable international regulations.

• Knowledge of software development in accordance with IEC 62304 and IEC 82304.

• Proficient in product and process development concepts, including change control and risk management.

• Ability to coordinate and present technical and project management overviews without assistance.

• Demonstrated ability to work independently.

• Problem Solving – Apply DMAIC and statistical techniques to address issues and investigations.Resourceful and independent.

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 - $143,000 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 and/or long-term incentive. 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.

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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.