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    Sr. Software Design Assurance Engineer - Los Angeles, United States - Medtronic

    Medtronic
    Medtronic Los Angeles, United States

    3 weeks ago

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    Description

    Careers That Change Lives

    The Senior Software Quality Engineer works as part of the core new product development team and sustaining to drive the software development activities for glucose sensing technology and automated insulin delivery systems to impact diabetics across the world. Solutions include insulin pumps, data driven solutions mobile and web apps and cloud infrastructure services.

    In this role you will be a part of a fast-paced cross-functional team that works with latest generation of embedded solutions to maximize safety and minimize user burden. #MDTDiabetesReferralCampaign

    :

    The Diabetes Operating Unit focuses on improving the lives of those within the global diabetes community. As a business, we strive to empower people with diabetes to live life on their terms by delivering innovation that truly matters and providing support in the ways they need it. We're committed to meeting people with diabetes where they are in their journey, always with an aim to make their lives easier. Our portfolio of innovative solutions are designed to provide customers greater freedom and better health, helping them achieve better glucose control, while spending less time managing their disease.

    A career at Medtronic is like no other. We're purposeful. We're committed. And we're driven by our Mission to alleviate pain, restore health and extend life for millions of people worldwide.

    A Day in the Life

    Responsibilities may also include the following and other duties may be assigned.

  • Lead as a quality core/extended team member responsible for driving quality into the embedded software solutions in accordance with IEC 62304.
  • Lead the collaborative quality strategy for projects in alignment with business goals for cross-functional teams including R&D/Regulatory/Marketing/Operations.
  • Lead quality focused design and development of software within the software development lifecycle (Agile/waterfall/ SAFe/DevOps) by defining the requirements, design, verification and validation plan and strategies while maintaining traceability.
  • Participate in design reviews for the system as well as review and approve design input/design output artifacts including requirements, design documents, code review reports, test results. verification and validation reports and defects.
  • Lead and conduct risk management activities including system risk analysis (ISO14971) and software FMEA's.
  • Lead and drive CAPA (Corrective and Preventative Action) projects.
  • Participate in both internal and external regulatory audits and inspections.
  • Lead quality improvement projects to include compliance standards for software quality operating methods, processes, and procedures (such as ISO13485/IEC62304/HIPAA/FDA/Security Standards/Data Privacy)
  • Define appropriate metrics to measure product quality and drive reliability.
  • Develops, modifies, applies, and maintains standards for software systems quality operating methods, processes, and procedures.
  • Conducts evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification and validation.
  • Defines appropriate measures to ensure product quality.
  • Develops overall operating criteria to ensure implementation of the software quality program according to project, process and contract requirements and objectives.
  • Ensures that projects and process control documentation are compliant with requirements, objectives and/or contracts.
  • Reviews software systems design, change specifications, and plans against contractual and/or process requirements.
  • Reviews include applicable specifications, materials, tools, techniques, and methodologies.
  • Provides or directs verification and validation of software system requirements, traceability, and testability.

    • Must Have: Minimum Requirements

    Bachelor's Degree in Engineering, Science or Technical Field with 4+ years of experience in Engineering, Software Development and/or Quality

    OR

    Advanced Degree Engineering, Science or Technical Field with 2+ years of experience in Engineering, Software Development and/or Quality.

    Nice to Have

  • Experience in software design, development, verification, validation and testing activitie for embedded software.
  • Experience executing in the SDLC environment leveraging ALM tools (Eg: PTC Integrity/Atlassian Suite/TFS,/MATLAB), defect tracking tools (Eg:Jira), development tools (Git), test tools (Eg: Selenium/JUnit), CI/CD tools (Jenkins).
  • Ability to author technical reports, business correspondence and standard operating procedures.
  • Exposure with embedded C/C++ software.
  • Experience executing in the SDLC environment leveraging ALM tools (Eg: PTC Integrity/Atlassian Suite/TFS), defect tracking tools (Eg:Jira), development tools (Git), test tools (Selenium/JUnit), CI/CD tools (Jenkins).
  • Exposure to medical device compliance standards (such as ISO13485/IEC62304/HIPAA/FDA/Security Standards/Data Privacy).
  • Ability to author technical reports, business correspondence and standard operating procedures.
  • Exposure to medical device compliance standards (such as ISO13485/IEC62304/HIPAA/FDA/Security Standards/Data Privacy).
  • Exposure to medical device compliance standards (such as ISO13485/IEC62304/HIPAA/FDA/Security Standards/Data Privacy).
  • Certified scrum master or SAFe or Black Belt or Green Belt or CQE preferred.
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