Sr. Principal Software Quality Engineer - Hybrid

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Job Description

Your Role at Baxter

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.

What you will be doing

• 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.