Senior Principal Software Quality Engineer

1 week ago

Bellevue, Washington, United States Hill-Rom Full time
About the Role

We are seeking a highly skilled Senior Principal Software Quality Engineer to join our team at Baxter. As a key member of our software development team, you will be responsible for ensuring the quality and reliability of our medical device software.

Key Responsibilities
  • Provide technical and strategic feedback on medical device software, digital health, and cybersecurity aligned with applicable regulations and standards.
  • 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) and provide Quality Engineering input, review, and approval of the Design History File (DHF) and associated documentation.
  • 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.
  • 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.
Requirements
  • B.S./M.S. in a relevant engineering field or equivalent scientific degree.
  • Minimum of eight (8) plus years of progressive Quality Engineering experience in the medical device industry with hands-on support for software development.
  • Strong 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.
  • 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.
  • 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 a 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.
About Baxter

Baxter is a global leader in medical technology and a pioneer in the development of innovative medical devices and therapies. We are committed to improving patient outcomes and enhancing the quality of life for people around the world.

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and experienced Quality Engineer looking for a new challenge, we encourage you to apply for this exciting opportunity.

  • Senior Principal Software Engineer

    3 weeks ago

    Bellevue, Washington, United States Northrop Grumman Full time

    Job Title: Sr. Principal Engineer SoftwareJob Summary:We are seeking a highly skilled Sr. Principal Engineer Software to join our team at Northrop Grumman. The successful candidate will have a strong background in software development and a proven track record of delivering high-quality products.Key Responsibilities:Lead the development of software systems,...

  • Senior Principal Software Quality Engineer

    3 weeks ago

    Bellevue, Washington, United States Hill-Rom Full time

    About the RoleWe are seeking a highly skilled Sr. Principal Software Quality Engineer to join our team at Baxter. As a key member of our software development team, you will be responsible for ensuring the quality and reliability of our medical device software.Key ResponsibilitiesProvide technical and strategic feedback on medical device software, digital...

  • Principal Software Engineer

    3 weeks ago

    Bellevue, Washington, United States Northrop Grumman Full time

    Job Title: Principal Engineer SoftwareNorthrop Grumman is seeking a highly skilled Principal Engineer Software to join our team in Bellevue, NE.Job Summary:We are looking for a talented software engineer with a strong background in software development and a passion for innovation. The successful candidate will have a broad skill set balanced between...

  • Senior Software Engineering Lead

    4 weeks ago

    Bellevue, Washington, United States Northrop Grumman Full time

    Job Title: Sr. Principal Engineer SoftwareNorthrop Grumman is seeking a highly skilled Sr. Principal Engineer Software to join our team in Bellevue, NE.About the Role:This is a challenging and rewarding opportunity for a seasoned software engineer to lead and contribute to the development of cutting-edge software systems. The successful candidate will have a...

  • Senior Software Architect

    4 weeks ago

    Bellevue, Washington, United States Walgreens Full time

    Job Title: Principal Software EngineerJob Summary:As a Principal Software Engineer at Walgreens, you will play a leading role in designing, developing, and testing software systems or applications for software enhancements and new products, including cloud-based or internet-related tools for highly strategic and complex/high risk undertakings.Key...

  • Senior Software Engineer

    3 weeks ago

    Bellevue, Washington, United States Chelsoft Solutions Co Full time

    About the RoleWe are seeking a highly skilled Senior Software Engineer to join our team at Chelsoft Solutions Co. As a key member of our frontend engineering team, you will play a critical role in developing a seamless checkout experience for our customers.As a Senior Software Engineer, you will collaborate closely with architects, product managers, UX...

  • Principal Software Engineer: Front-end Expert

    2 weeks ago

    Bellevue, Washington, United States Walmart Full time

    Job SummaryWe are seeking a highly skilled Principal Software Engineer to join our team in Bellevue, WA. As a key member of our front-end development team, you will be responsible for designing, developing, and implementing scalable and efficient front-end solutions that meet the needs of our customers.About the RoleThis is a challenging and rewarding role...

  • Senior Software Engineer

    3 weeks ago

    Bellevue, Washington, United States WALGREENS Full time

    About the RoleWe are seeking a highly skilled and experienced Senior Software Engineer to join our team at Walgreens. As a key member of our software engineering team, you will be responsible for designing, developing, and testing software systems and applications that impact our digital and online platforms.Key ResponsibilitiesDesign and develop software...

  • Senior Software Engineer

    4 weeks ago

    Bellevue, Washington, United States WALGREENS Full time

    About the RoleWe are seeking a highly skilled Senior Software Engineer to join our team at Walgreens. As a key member of our software development team, you will be responsible for designing, developing, and testing software systems and applications.Key ResponsibilitiesDesign and develop software systems and applications using Agile development...

  • Senior Software Engineer

    3 weeks ago

    Bellevue, Washington, United States Walmart Full time

    About the RoleWe are seeking a highly skilled Senior Software Engineer to join our team at Walmart Commerce Technologies in Bellevue, WA. As a Senior Software Engineer, you will play a key role in designing, developing, and maintaining our software systems, ensuring they are reliable, scalable, and high-performing.Key ResponsibilitiesDesign and develop...

  • Senior Software Engineer

    2 weeks ago

    Bellevue, Washington, United States RESULTICKS Full time

    About the RoleWe are seeking a highly skilled Senior Software Engineer to join our team at Resulticks. As a key member of our product development team, you will be responsible for designing, developing, and deploying scalable software solutions that meet the needs of our customers.Key Responsibilities:Design and develop software solutions using a range of...

  • Senior Software Engineer I

    2 weeks ago

    Bellevue, Washington, United States Symetra Life Insurance Company Full time

    Job Title: Senior Software Engineer IAt Symetra Life Insurance Company, we are seeking a highly skilled Senior Software Engineer I to join our team. As a key member of our software development team, you will be responsible for designing, developing, deploying, and operationalizing highly scalable, available, and reliable APIs.Key Responsibilities:Design and...

  • Principal Software Architect

    4 weeks ago

    Bellevue, Washington, United States WALGREENS Full time

    About the RoleWe are seeking a highly skilled Principal Software Engineer to join our team at Walgreens. As a key member of our software development team, you will play a leading role in designing, developing, and testing software systems and applications for our cloud-based and internet-related tools.Key ResponsibilitiesDesign and develop software systems...

  • Senior Director of Software Engineering

    2 weeks ago

    Bellevue, Washington, United States FIS Full time

    About the RoleWe are seeking a highly experienced Senior Director, Software Engineering to join our FIS Financial Intelligence team. As a key member of our leadership team, you will be responsible for driving the development of our cutting-edge financial intelligence platform.As a Senior Director, you will lead a team of software engineers and technical...

  • Senior Software Engineer

    4 weeks ago

    Bellevue, Washington, United States WALGREENS Full time

    About the RoleWe are seeking a highly skilled and experienced Senior Software Engineer to join our team at Walgreens. As a key member of our engineering team, you will be responsible for designing, developing, and testing software systems and applications that impact our digital and online platforms.Key ResponsibilitiesSoftware Development: Plan, design,...

  • Senior Director of Software Engineering

    2 weeks ago

    Bellevue, Washington, United States Jobs for Humanity Full time

    About the RoleWe are seeking a highly skilled Senior Director of Software Engineering to join our team at FIS Global. As a key member of our Financial Intelligence team, you will be responsible for leading the development of our cloud-based financial platform. Your expertise in software engineering, technical leadership, and cloud architecture will be...

  • Senior Software Engineer

    3 weeks ago

    Bellevue, Washington, United States AstrumU Full time

    About AstrumUAstrumU is a data services company based in Bellevue, WA that is leveling the playing field by identifying skills gap recommendations, so that individuals can achieve their career objectives. Our mission is to quantify the return on educational investments for all learners, education providers, and employers, so everyone can maximize their...

  • Senior Software Engineer

    3 weeks ago

    Bellevue, Washington, United States Snowflake Computing Full time

    About SnowflakeSnowflake is a cloud-based data platform that enables businesses to store, process, and analyze large amounts of data. Our platform is designed to be highly scalable, secure, and flexible, making it an ideal solution for organizations of all sizes.Job SummaryWe are seeking a highly skilled Senior Software Engineer to join our Data Engineering...

  • Software Engineering Lead

    4 weeks ago

    Bellevue, Washington, United States Northrop Grumman Full time

    Job SummaryWe are seeking a highly skilled Principal Engineer Software to join our team at Northrop Grumman Defense Systems in Bellevue, NE. As a key member of our software development team, you will be responsible for designing, developing, and maintaining complex software systems.Key ResponsibilitiesLead the development of software systems, ensuring they...

  • Senior Software Engineer

    3 weeks ago

    Bellevue, Washington, United States Walmart Full time

    About the RoleWe are seeking a highly skilled Senior Software Engineer to join our team at Walmart Global Tech in Bellevue, WA. As a Senior Software Engineer, you will play a key role in designing, developing, and maintaining software applications that support our business operations.Key ResponsibilitiesDesign, develop, and test software applications using...