Principal Engineer, Quality

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

As a Principal Engineer, Product Quality, you will ensure the establishment and execution of world-class Design Control processes that deliver safe and reliable products, while also enabling speed to market. You will partner with the Sustaining Engineering team in the design maintenance of FDA Class I and Class II medical devices to ensure that design control principles are followed, and that safety & efficacy are demonstrated. At all times throughout the process, you will identify and mitigate risks.

Your Team

We are a team of inquisitive individuals who embrace a collaborative environment to take on sophisticated challenges that meet the needs of our patients. We often need to change directions and respond to issues to avoid disruptions in our fast-paced manufacturing environment. Together, we build and maintain a positive work environment.

Our team is dedicated to quality. Delivering life-saving products is about getting them right, and our technical expertise and experience working in a manufacturing environment empower us to meet that challenge.

When you join us, you will work with committed individuals who trust each other to deliver on the tasks at hand. We support innovation and out-of-the-box thinking balanced with collaboration across functions and other teams. Our leadership understands the need for continuous education and provides opportunities for further development.

What You'll Be Doing

• Provide quality assurance support and oversight for product design activities including: Design and Development Planning, Design Input, Design Output, Design Review, Design Verification and Validation, Design Transfer, Design Changes.

• Ensure compilation and maintenance of product Design History Files.

• Partner with Sustaining Engineering and Research & Development to ensure design reviews are thorough and robust.

• Review and approve Design Verification and Validation test plans, protocols and reports; guide the use of robust statistical techniques.

• Document traceability of requirements through design output and to design verification and/or design validation.

• Insist on early requirements' maturation, early test plan/script development, and design input requirements that are indicative of real world use case environment and customer needs.

• Review intended use validation for non-product software and tools used in the development process.

• Actively participate with design teams on developing product Risk Management Files; ensure risk assessments adequately address safety and efficacy and are compliant to the highest standards.

• Perform DHF audits of other products as an independent reviewer.

• Support external regulatory and customer audits.

• Support nonconformance and CAPA investigations and improvement action plans.

• Collaborate with global Design Assurance team to drive continuous improvement, including development of standard work, striving for a world-class Product Development Process.

What You'll Bring

• Bachelor's Degree in Engineering.

• 5+ years' experience in medical device or other regulated technical industry (e.g., aerospace, automotive, defense).

• Experience with development of mechanical or electronic devices is required.

• Experience with manufacturing & software development processes is a plus.

• Strong working knowledge of design controls as required by FDA 21 CFR 820.30, European Medical Device Regulation and ISO 13485 product realization.

• Knowledge of Quality Management Systems beyond design control compliant with FDA 21 CFR 820 and ISO 13485, product safety standards (e.g., IEC and ANSI/AAMI), Human Factors/Usability Engineering, statistical analysis methods, ISO 14971 Risk Management and cybersecurity controls are a plus.

• ASQ or related quality certification is preferred.

• Detail oriented with strong organizational and record keeping skills

• Problem solving and root cause analysis skills

• Systems Engineering knowledge, experience with complex multifunctional systems

• Ability to facilitate cross-functional team meetings.

• Strong written and oral communications skills using English language; ability to succinctly and clearly describe complex issues in meaningful ways.

• Ability to engage different functions in meaningful discussions and maintain enthusiasm for efforts.

• Proactive and timely in execution of assigned tasks

• Ability to be flexible and adaptable to changing priorities

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.

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 of 3 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 $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, commission, 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.

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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.

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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.