Sr. Principal Software Quality Engineer - Hybrid

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.

Do you want to use your Software Quality Engineer skills to make a difference in the world of Cardiology? Bardy Diagnostics is an exciting, fast growing organization within Baxter with a unique and compelling product looking for a strong Sr. Principal Software Quality Engineer to help us achieve our mission!

Join a multi-skilled team dedicated to developing innovative wearable cardiac arrhythmia monitors and associated cloud-based and supporting software. In this role, you'll work in a small and dedicated team passionate about the development of these products and supporting software. The ideal candidate will be motivated by the unique challenges and opportunities of a fast-growing medical device organization, by solving sophisticated technical problems, and have a penchant for continuous improvement and Quality Engineering excellence.

• Provide technical and strategic feedback associated with medical device software (SaMD and SiMD), digital health, and cybersecurity aligned with applicable regulations, standards, and business needs.
• Establish and cultivate positive relationships with cross-functional stakeholders and product development team members to optimize the success of development projects.
• Lead the development and maintenance of the Risk Management File (RMF) including risk management plans, hazards analysis, dFMEAs, pFMEAs, and risk management report.
• Provide Quality Engineering input, review, and approval of the Design History File (DHF) and associated documentation. Responsible for quality oversight and approval of software product development plans, design inputs and outputs, verification and validation, and review of test planning, protocols, and reports.
• Provide guidance on statistical methods and analyses for design verification and validation, including test method validation.
• Serve as the SME for software quality and collaborate with teams on code reviews, software security analysis, defect and vulnerability triage, creation and maintenance of sBOMs, etc., and lead implementation of best practices for software quality processes.
• Participate in design reviews to ensure the effective development, transfer, and maintenance of the product throughout the product lifecycle.
• Support the successful transfer and hyper-care phase of design and design modifications into production/field deployment.
• Support/lead non-product software assessments and qualification efforts.
• Lead changes to the Quality System based on new regulations, mentorship documents, industry standards, and observations.
• Own the resolution and timely closure of CAPAs as they relate to the design control process.
• Follow documented procedures for all activities related to the Company's Quality System.
• Support other areas of the Quality System and perform other tasks as defined by Management.

What do you bring

• B.S./M.S. in relevant engineering field (e.g., biomedical, computer science, software, electrical, etc.) or equivalent scientific degree.
• 10 plus years of progressive Quality Engineering experience in the medical device industry with hands-on support for software development.
• Strong solid understanding of US and international medical device regulations and standards, including 21 CFR 820, ISO 13485, IEC 62304, IEC 82304, AAMI TIR45, ISO 14971, AAMI TIR57, IEC 60601 series, IEC 62366.
• Solid understanding of developmental best practices for medical device software, digital health software, Medical Device Data Systems, and cloud-based systems.
• Solid understanding of Secure Product Development Framework (SPDF), including security risk management per AAMI TIR57, creation and maintenance of sBOMs, security architecture, security testing, transparency, and post-market vulnerability management.
• Experience in the deployment of quality engineering tools for design and process improvement; extensive knowledge of statistical tools and data analysis techniques.
• Strong verbal and written communication and presentation skills. Demonstrated interpersonal skills including strong negotiation skills.
• Excellent writing skills to develop clear and logical information and conclusions based on design documentation.
• Ability to manage numerous projects while independently prioritizing work, growing the quality culture, and being an advocate for quality and regulatory compliance.
• Organized self-starter, able to work in a fast-paced environment.
• Ability to work independently and as part of team, strong collaborative skills.
• Ability to manage competing priorities and "wear many hats."
• Must be comfortable working in a high-growth company with rapidly evolving needs, responsibilities, and expectations.
• Proficient in Microsoft Office, Azure DevOps, Adobe Acrobat, statistical analysis (e.g., Minitab), vulnerability scanning, and other business software.
• Solid understanding of artificial intelligence and SaMD preferred.
• Certified ASQ CQE, and/or Six Sigma Black Belt/Green Belt preferred.
• Experience working within an AAMI TIR45 framework for the development of SaMD preferred.
• Experience supporting development of cloud-based software and deep understanding of cloud infrastructure preferred.
• Experience in security risk management and ISO/IEC 27001 preferred.

Baxter is committed to supporting the need for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person to support our Mission.

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 our employees, and we strive to be more transparent with our pay practices. To that end, this position has a salary range of $120,000 to $165,000 and also includes an annual incentive bonus. The above range represents the expected salary range for this position. The actual salary may vary based upon several factors including, but not limited to, relevant skills/experience, time in the role, business line, and geographic/office location.

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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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