Sr. Principal Software Quality Engineer

Aquí es donde salvas y sostienes vidas

En Baxter, estamos profundamente conectados por nuestra misión. No importa tu rol en Baxter, tu trabajo tiene un impacto positivo en la gente alrededor del mundo. Sentirá un propósito en toda la organización, ya que sabemos que nuestro trabajo mejora los resultados para millones de pacientes.

Los productos y terapias de Baxter se encuentran en casi cada hospital del mundo, el clínicas y en los hogares. Por más de 85 años hemos sido pioneros en innovaciones médicas significativas que transforman el cuidado en salud.

Juntos creamos un lugar donde somos felices, exitosos y nos inspiramos mutuamente. Aquí es donde puedes hacer tu mejor trabajo.

Únete a nosotros en la intersección de salvar y sostener vidas-donde tu propósito acelera nuestra misión.

Your Role at Baxter
In this role you will partner with development teams and cross-functional stakeholders to support the development of design control, risk management, and compliance deliverables associated with new product development of medical device software, digital health products, cloud-based systems, and AI/ML algorithm-based products.

What You'll be doing

• Partner with development teams and cross-functional stakeholders to provide technical and strategic feedback associated with the development of medical device software (SaMD and SiMD), digital health products, cloud-based systems, AI/ML algorithms and cybersecurity aligned with applicable regulations, standards, and business needs.
• Provide Quality Engineering input, review, and approval of the Design History File (DHF) and associated design control documentation for medical device software. Responsible for quality oversight and approval of software product development plans, risk management, design inputs and outputs, verification and validation, and review of test planning, protocols, and reports.
• Lead activities for establishing, implementing, and maintaining medical device software Risk Management Files (RMF), including analyzing and evaluating risks, controlling identified risks, and monitoring the effectiveness of the risk control measures.
• Establish and cultivate positive relationships with cross-functional stakeholders and product development team members to optimize the success of development projects.
• 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.
• Complete other duties as assigned.

What you'll bring

• B.S./M.S. in relevant engineering field (e.g., biomedical, computer science, software, electrical, etc.) or equivalent scientific degree.
• Minimum of 10+ plus years of progressive Quality Engineering experience in the medical device industry with hands-on support for software development.
• Experience supporting development of medical device software (SaMD and SiMD), digital health products, cloud-based systems, and AI/ML algorithms.
• Experience supporting the development of design control and design history file documentation for medical device software from inception through successful Design Transfer.
• Experience supporting software development teams using Agile development methodologies including supporting iteration planning, execution, demonstrations, and retrospective activities.
• 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.