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Senior Principal Software Quality Engineer

Baxter International

Raleigh, NC
Full Time
Senior
120k-165k
about 1 month ago

Job Description

About the Role

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 This is where your expertise helps people 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. 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 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.

Key Responsibilities

  • 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.
  • Support sustainment engineering projects and ensure product development activities related to verification and validation are fully compliant with quality system procedures.
  • Prepare and manage all Design Assurance required deliverables.
  • Assist in identification and mitigation of product or process-related risks.

Requirements

  • B.S. in Engineering or other technical degree, preferably in Computer Science/Engineering or Electronics/Electrical Engineering.
  • 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 closely connected to these areas.
  • Software Quality experience is highly sought, especially in the medical device industry.
  • Knowledge of software development lifecycle processes and standards.
  • Proven ability to perform and influence in cross-functional team environments and utilize effective interpersonal skills.

Nice to Have

  • Knowledge of AAMI 62304 standard.
  • Product Design experience may be considered in lieu of Quality Assurance experience.
  • Software development experience in a regulated industry.
  • Understanding of software development tools and methods for medical devices and/or other regulated industries.
  • Familiarity with Quality System Regulations, Medical Device Directive, ISO Quality System Standards.
  • Knowledge of 21 CFR 820.30, ISO13485, IEC62304.
  • Knowledge of EN ISO 14971:2012; safety by design; Risk Management structure.

Qualifications

  • Educational background with a B.S. in Engineering or a related technical field.

Benefits & Perks

  • Comprehensive compensation and benefits packages including medical and dental coverage starting day one.
  • Insurance coverage for life, accident, short-term and long-term disability, and business travel insurance.
  • Financial and retirement benefits such as Employee Stock Purchase Plan (ESPP) and 401(k) Retirement Savings Plan (RSP).
  • Flexible Spending Accounts, educational assistance, paid holidays, paid time off (20-35 days), family and medical leaves, paid parental leave.
  • Additional benefits including commuting benefits, Employee Discount Program, Employee Assistance Program (EAP), and childcare benefits.

Working at Baxter International

We create a collaborative, innovative environment that values continuous education, professional development, and a positive work atmosphere. Our team embraces challenges, supports each other, and is dedicated to delivering life-saving products with high quality and safety standards.

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Job Details

Posted AtJun 24, 2025
Job CategoryQA Engineering
Salary120k-165k
Job TypeFull Time
Work ModeOnsite
ExperienceSenior

Job Skills

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About Baxter International

Website

baxter.com

Company Size

10000+ employees

Location

Raleigh, NC

Industry

Medical Equipment and Supplies Manufacturing

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