Senior Principal Software Quality Engineer

Baxter International Inc.; Raleigh (NC); On-site; USD 125,000 - 150,000; Full time

Job summary

Baxter International Inc. seeks a Senior Principal Software Quality Engineer to lead quality assurance efforts for new medical device products. Candidates should have a strong background in engineering, a minimum of 8 years in regulated industries, and excellent problem-solving skills. This role emphasizes teamwork and collaboration to ensure high-quality design and compliance with regulatory standards.

Qualifications

• Minimum 8 years in a medical device or regulated industry.
• 2+ years of Quality experience desirable.
• Knowledge of AAMI 62304 standard is valuable.

Responsibilities

• Lead Design Assurance functions for new product development teams.
• Ensure compliance with Design Control and Quality System elements.
• Assist in risk identification and mitigation related to products.

Skills

Problem Solving

Interpersonal Skills

Team Collaboration

Education

B.S. in Engineering or related technical degree

Tools

Software Development Lifecycle Tools

Quality System Regulations

Job description

Senior Principal Software Quality Engineer

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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. What you'll be doing: 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. What you'll bring: 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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Engineering and Information Technology

• Industries

  Medical Equipment Manufacturing

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