Insulet Corporation Sr. Software QA Engineer in Billerica, Massachusetts
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.
Create and execute test plans, test designs and test cases.
Support Data Science group in the verification of automated reports.
Work closely with the software development team to identify improvements.
Influence the requirements definition and software design to maximize testability.
Develop and maintain test database for automated validation test of software revisions.
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.
BS in Software Engineering, Computer Science or similar field; 5+ years of experience in software design and software quality assurance; 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.
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.
Software skills, including C#, Perl, Python, and embedded C is a plus.
Familiarity with IEC 62304, ISO 14971, FDA regulations and international standards applicable to medical device software development, verification and validation is a plus.
Proven record developing and executing software test protocols for complex devices
Software test group experience strongly preferred
Experience working with products from the prototype through 510(k)/ISO clearance and commercialization is preferred
Strong written, verbal, interpersonal and presentation skills.
External Company Name: Insulet Corporation
External Company URL: http://www.myomnipod.com/
Street: 600 Technology Park Drive