Sr Staff Software Test Engineer, Embedded Software (Manual & Automation, Medical Devices)

Insulet is looking for a self-motivated Senior Staff 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, hazard analysis, requirements traceability, software code analysis, defect tracking, software metrics, configuration management, and software tool validations.

Responsibilities

• 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.

• Represent SQA in the core team meetings.

• 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.

• Provide direction/guidance to the QA team.

• Remove blockers for the SQA team.

• Design the path forward for the team.

• Work with the scrum Master to identify way on how deprioritize “Nice to have feature” to pull in timelines, if needed.

• Keep track of the Testing board and tools inventory for the team.

• Performs other duties as required.

Required Leadership/Interpersonal Skills & Behaviors

• Highly self-motivated with a proactive mindset

• Strong ability to quickly learn and adapt to new technologies

• Demonstrated experience mentoring and developing junior team members

• Collaborative team player with a leadership mindset

• undefined

  Required Skills and Competencies

   

  Excellent verbal and written communication skills

  Ability to communicate effectively across all levels of the organization

  Proficiency in Python scripting with strong debugging capabilities

  Prior experience in a software testing or software quality assurance team

  Strong interpersonal, documentation, and presentation abilities

   

  Education and Experience

  Bachelor’s degree in software engineering, Computer Science, or related field

  10+ years of hands-on experience in software quality assurance, preferably in real-time systems within regulated industries; or an equivalent combination of education and experience

  At least 2 years of experience in a lead or senior QA role

  Experience supporting products from prototype through FDA 510(k)/ISO submission and commercialization is preferred

  Deep understanding of QA principles, software testing best practices, and quality metrics

  Practical experience with modern development and QA tools (e.g., version control, CI/CD, test management)

  Proven track record in developing and executing comprehensive software test protocols for complex systems

  Familiarity with relevant standards and regulations (e.g., IEC 62304, ISO 14971, FDA regulations) is a strong plus.
  
  

  Additional Information

  The position is hybrid at our Acton office.

  Travel is estimated at 0% but will flex depending on business needs.

Additional Information: