Insulet Corporation

  • Sr. Software QA Engineer-Lifecycle

    Job Locations US-MA-Billerica | US-MA-Billerica
    Posted Date 5 months ago(5 months ago)
    Engineering / Program Management
  • Position Summary

    Insulet is looking for a self-motivated Senior Software Quality Assurance Engineer to be a part of the testing effort related to product development and product modifications.  The position is responsible for ensuring that software for on-market products has been effectively and efficiently verified & validated prior to its release as well as that the designs effectively meet their requirements.  Software quality assurance efforts are lifecycle oriented, beginning during product requirements development and continuing throughout its lifetime.


    The Position will initially report to R&D Engineering to support a new product’s release to production and thereafter to Life Cycle Engineering Leaders.   Location will be at Insulet’s Headquarters in Billerica, MA.


    • Creating and executing test plans, test designs and test cases and generating test reports for them.
    • Creating and updating Trace matrices between requirements and Tests.
    • Work closely with the software development team to identify improvements.
    • Influence the requirements definition and software design to maximize testability.
    • Oversee and influence development of test objects to meet needs of protocol.
    • Develop and Extend protocols and plans as device features evolve.
    • Participate in product design reviews.
    • Performs other duties as required.

    Education and Experience


    Minimum Requirements:


    • BS in Software Engineering, Computer Science or similar field; 5+ years hands on experience in software quality assurance associated with real time embedded software systems in regulated industry and/or equivalent combination of education and experience.
    • Experience working with products from the prototype through 510(k)/​ISO clearance and commercialization is preferred.
    • Thorough understanding of software quality assurance principles, practices and metrics as well as software development and testing best practices that foster high quality software.
    • Hands on experience using modern software development and quality assurance tools.
    • Proven record developing and executing software test protocols for complex medical devices
    • Familiarity with IEC 62304, ISO 14971, FDA regulations and international standards applicable to medical device software development, verification and validation a plus.


    Preferred Skills and Competencies:       

    • Effective verbal and written communication skills.
    • Able to communicate at multiple levels of an organization.
    • Deep knowledge of embedded software testing (black-box and white-box)
    • Software test group experience strongly preferred
    • Strong written, verbal, interpersonal and presentation skills.
    • Physical Requirements:

    • General office environment, may sit for long periods of time.


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