Senior Principal Software 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.

You are a problem solver. Complex projects or unexpected challenges are just opportunities to bring your considerable abilities to use. Whether working independently or with a trusted team, you are always ready to tackle a project and work hard to find solutions.

Your talent is needed across a wide variety of industries. As a Senior Principal Software Quality Engineer, you have a wide array of career choices, but are motivated by the opportunity to work in a company that supports innovation, professional development, and a purposeful mission.

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 Healthcare Solutions and Technology 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 a team of 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.

As a Senior Principal Software Quality Engineer, you will have the opportunity to lead by example and enjoy mentoring and learning from others. Here, you are trusted to manage your own time and are given opportunities to grow your career as you wish.

This position is an embedded partner member in R&D project teams in the development of complex medical & non-medical software. You have responsibility in ensuring that software and device products are designed, developed, verified, validated, and delivered to high quality and safety on assigned projects. You will support project teams on both the New Product Development and sustainment engineering processes and will also participate in various Design Assurance improvement initiatives to improve the overall quality of new product designs and the company's regulatory compliance profile. Will frequently interact with and influence project team members, project team's leaders, and functional leaders in R&D and Quality.

• Responsible for all Design Assurance functions as a core team member on new product development (NPD) teams, ensuring the team complies with all portions of Design Control and related Quality System elements. Will also support sustainment engineering projects.
• Prepare and manage all Design Assurance required deliverables as well as support the remainder of the team in developing a quality product that meets regulatory requirements.
• Responsible for ensuring product development activities related to verification and validation are fully compliant to the quality system procedures.
• Assist in identification and mitigation of product or process-related risks.
  

• B.S. in Engineering or other technical degree required, preferably Computer Science/Engineering or Electronics/Electrical Engineering.
• Software Quality experience is highly sought, especially in the medical device industry. Knowledge of AAMI 62304 standard is valuable.
• Minimum 8 years of experience in medical device or other regulated technical industry (e.g., aerospace, automotive, defense) in a design/development/quality role or in a role closely connected to design/development/quality is required.
• Proven ability to perform and influence in cross-functional team environments and utilize effective interpersonal skills
• 2+ years of Quality experience desired.
• Product Design experience may be considered in lieu of Quality Assurance experience.
• Software development experience in a regulated industry is desirable.
• Knowledge of software development lifecycle processes and standards required.
• Understanding of software development tools and methods for medical devices and/or other regulated industries desirable.
• Familiarity of Quality System Regulations, Medical Device Directive, and ISO Quality System Standards.
• Knowledge of 21 CFR 820.30, ISO13485, IEC62304 desirable.
• Knowledge of EN ISO 14971:2012; safety by design; Risk Management structure desirable.

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 $120,000 - $165,000 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.

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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

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