Director, Design Quality - Infusion Systems

Baxter; Round Lake Beach (IL); On-site; USD 176,000 - 242,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Employee Stock Purchase Plan (ESPP)

Paid time off 20–35 days

Flexible workplace policy

Commuting benefits

Job summary

Baxter seeks a Director of Design Quality to lead the design quality for infusion systems, pumps, sets, and health software. You will drive quality strategies, partner with regulatory and product teams, and ensure compliance with global standards.

You are a hands-on leader who shapes design quality via KPIs, risk management, and lifecycle activities, delivering safe, high‑quality medical devices in a dynamic environment.

Qualifications

• Bachelor's in engineering or related field is required
• 10+ years of experience in quality/engineering/product development
• 7+ years of managerial experience
• Knowledge of medical device regulatory standards and lifecycle

Responsibilities

• Lead a team of Design Quality professionals responsible for product development, lifecycle management, and post-market monitoring
• Develop and implement design quality strategies aligned with goals, standards, and regulatory requirements
• Establish and maintain design quality KPIs and drive continuous improvement
• Provide expertise on design quality to cross-functional teams and external partners
• Collaborate with Quality System stewards to improve the Quality System
• Stay abreast of industry trends and regulatory changes and apply insights
• Represent Baxter in industry forums and standards committees

Skills

Quality leadership

Regulatory knowledge

Risk management

Quality engineering

Team leadership

Education

Bachelor's degree in engineering, science, or related field

Advanced degree

Job description

This is whereyour 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

This is where your creativity addresses challenges

As Director of Design Quality, you will ensure the highest quality design and development of Infusion Systems products including infusion pumps, sets, and health software.

You are creative, detailed, and a heads-down do-er. You embrace a challenge and truly apply the collaborative powers of your team to produce great results. You are motivated by work that is never the same from one day to the next.

What you'll be doing

• Lead a team of Design Quality professionals who are responsible for product development, lifecycle management activities, and post-market monitoring.

• Develop and implement comprehensive design quality strategies, ensuring alignment with company goals, industry standards, and regulatory requirements. Set and lead priorities within the team based on these strategies and business needs.

• Establish and maintain design quality and key performance indicators, conducting regular reviews and analyses to drive continuous improvement initiatives.

• Serve as a subject matter expert on design quality matters, providing expertise and support to cross-functional teams and external partners.

• Partner with Quality System element stewards to develop, maintain, and improve the Quality System in relevant areas.

• Stay abreast of industry trends, new technologies, and regulatory changes, and incorporate relevant insights into strategies and initiatives.

• Represent the company in industry forums, conferences, and standards committees, sharing knowledge to the advancement of the medical device industry.

What you'll bring

• Bachelor's in engineering, science, or related field required; Advanced degree preferred.

• 10+ years of experience in quality, engineering, or a related product development function, 7+ years of managerial experience.

• Detailed understanding of the medical device, biologics, and combination product development cycle, knowledge of worldwide regulatory requirements and industry standards.

• Significant breadth and depth in quality decision‑making, risk management, and quality engineering.

• Conflict resolution skills including persuasive management techniques required.

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 $176,000 - $242,000 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.

Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes arequired minimum number of daysa 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.

US Benefits at Baxter (except for Puerto Rico)

• 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.

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.