Senior Principal Software Quality Engineer,

Baxter International Inc.; Raleigh (NC); On-site; USD 80,000 - 120,000; Full time

Job summary

An established industry player seeks a Senior Principal Software Quality Engineer to join their mission of saving and sustaining lives. In this pivotal role, you will lead Design Assurance functions, ensuring compliance with quality systems while working on innovative medical software projects. Collaborate with cross-functional teams to tackle complex challenges and enhance product quality and safety. This is an opportunity to grow your career in a supportive environment that values professional development and innovation. If you're passionate about making a difference in healthcare, this role is for you.

Qualifications

• 8+ years in medical device or regulated industry with design/development/quality focus.
• Knowledge of AAMI 62304 and risk management principles is valuable.

Responsibilities

• Lead Design Assurance functions on new product development teams.
• Ensure compliance with quality system procedures and regulatory requirements.

Skills

Software Quality

Cross-functional Team Collaboration

Risk Management

Regulatory Compliance

Problem Solving

Education

B.S. in Engineering

Computer Science/Engineering or Electronics/Electrical Engineering

Tools

Software Development Lifecycle Processes

Quality System Regulations

ISO Quality System Standards

Job description

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.

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.

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.