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 creativity addresses challenges

You are creative, thorough, and a heads-down do-er. You embrace a challenge and truly apply the collaborative powers of your team to produce great results. You are motivated by work that is never the same from one day to the next. As a Senior Principal Quality Engineer, you are unafraid of navigating through necessary internal processes to facilitate a product you deeply believe in. You can absorb and act on complex procedures and data and train your team or peers if needed. You take pride in getting things done quickly without sacrificing safety or quality.

Bardy Diagnostics (BardyDx), a division of Baxter International, is an innovator in digital health and remote patient monitoring, with a focus on providing the most diagnostically accurate and patient-friendly cardiac patch monitor in the industry. Currently, BardyDx has FDA 510(k) clearance and CE Mark approval for the Carnation Ambulatory Monitor (CAM) Patch, which is presently launched in the US, the UK, and Canada.

This position provides Quality Engineering leadership for software product development teams. Will be responsible for leading design control, risk management, and other Quality Engineering activities for new product development projects.

This position is located at our Bellevue, WA facility and is hybrid. Relocation assistance may be provided.

What you'll be doing

• Establish and cultivate positive relationships with cross-functional product development team members to optimize 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 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, and the software BOM; 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.
  

Secondary/backup duties and responsibilities

• Lead changes to the Quality System based on new regulations, guidance documents, industry standards, and observations.
• Lead the resolution and timely closure of CAPAs as they relate to the design control process.
• Support other areas of the Quality System and perform other tasks as defined by Management.
  

What you'll bring

• 8+ years of progressive Quality Engineering experience in the medical device industry with hands-on support for software development.
• B.S./M.S. in relevant engineering field (e.g., biomedical, software, electrical, etc.) or equivalent scientific degree.
• Experience with the application and implementation of FDA CFR 820, ISO 13485, ISO 14971, IEC 60601 series, IEC 62366, and IEC 62304 (including software unit and integration testing, SOUP, etc.).
• Experience in the design, development, verification, validation, and test activities for medical device software, digital health software, and cloud-based systems.
• Experience in the deployment of quality engineering tools for design and process improvement; extensive knowledge of statistical tools and data analysis techniques.
• Exceptional verbal and written communication skills and presentation skills.
• Exceptional attention to detail with the proven ability to wear many hats.
• Manage numerous projects while independently prioritizing work, growing the quality culture, and being an advocate for quality and regulatory compliance.
• 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), and other business software.
• Follow documented procedures for all activities related to the Bardy Diagnostics Quality System.
  

Preferred certifications

• Certified ASQ CQE, and/or Six Sigma Black Belt/Green Belt.
• Experience working within an AAMI TIR45 framework for the development of SaMD.
• Experience supporting development of cloud-based software and deep understanding of cloud infrastructure.
• Experience in security risk management and ISO/IEC 27001.

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 $80,000 to$180,000 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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The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.

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.

EEO is the Law 
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Pay Transparency Policy

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.

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