Insulet Corporation Senior SQA Engineer R&D in Billerica, Massachusetts

Insulet is looking for a self-motivated Senior Software Test Engineer to be a part of the testing effort related to product development and product modifications. This position assists in the software quality assurance efforts related to new product development and product modifications for the Research and Development group. The position is responsible for ensuring that new products have been effectively and efficiently verified and validated prior to their release for shipment and that these designs effectively meet documented and implied user needs and requirements. Software quality assurance efforts are lifecycle oriented beginning during product requirements development and continuing throughout its lifetime.

This position will also be part of validating software development tools to improve the overall quality of software, including peer reviews, software hazard analysis, requirements traceability, software code analysis, defect tracking, software metrics, configuration management, and software tool validations

  • 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.

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)/‚ÄčISO 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.

External Company Name: Insulet Corporation

External Company URL: http://www.myomnipod.com/

Street: 600 Technology Park Drive