Insulet Corporation
Senior Software Test Engineer, Embedded Software (Manual & Automation, Medical D
Insulet Corporation, Acton, Massachusetts, us, 01720
Overview
Insulet is seeking a self-motivated, highly skilled and detail-oriented
Senior Software Test Engineer
to lead testing efforts for embedded software systems in
regulated medical devices . This role involves designing and executing both manual and automated test strategies to ensure compliance, safety, and performance of embedded applications across various platforms. The ideal candidate will also have experience collaborating with
onshore and offshore QA teams
to drive global test execution and quality alignment. This position supports software quality assurance efforts related to new product development and product modifications for the Research and Development group, ensuring new products are verified and validated prior to release for shipment and that designs meet user needs and requirements. Software QA efforts are lifecycle-oriented from requirements development through the product lifecycle. This role will also be involved in validating software development tools to improve overall quality, including peer reviews, software hazard analysis, requirements traceability, software code analysis, defect tracking, software metrics, configuration management, test automation using an existing framework, and software tool validations. Responsibilities
Develop and maintain manual and automated test cases for embedded software. Perform functional, regression, performance, stress, and reliability testing. Ensure compliance with industry standards and internal quality benchmarks. Maintain detailed documentation of test plans, procedures, and results. Software requirement analysis, architectural and design specification reviews, and creating use cases. Identify and fill gaps in use case/test case. Create and execute test plans, test designs, and test cases; generate test reports. Create and update trace matrices between requirements and tests. Work closely with the software development team to identify improvements and maximize testability. Oversee development of test objects to meet protocol needs and extend protocols/plans as device features evolve. Participate in product design reviews and Agile/Scrum ceremonies. Mentor junior QA engineers and contribute to continuous improvement of QA processes. Coordinate with onshore and offshore teams using Jira, Confluence, Slack, and Teams; establish handoff protocols and defect resolution workflows across time zones. Required Skills And Competencies
5+ years of experience in embedded software testing, with a strong mix of manual and automation experience; at least 2+ years in medical device software testing. Familiarity with SDLC, test lifecycle, and Agile methodologies. Proficiency in Python, Jenkins, and test automation tools. Experience with products from prototype through 510(k)/ISO clearance and commercialization is preferred. Strong understanding of software quality assurance principles, practices, and metrics; knowledge of software development and testing best practices. Hands-on experience with modern software development and QA tools. Proven track record developing and executing software test protocols for complex medical devices. Document test protocols, procedures, and results in accordance with DHF and quality system documentation. Familiarity with IEC 62304, ISO 14971, FDA 21 CFR Part 820 and related medical device software standards. Strong analytical and problem-solving skills; excellent communication and documentation abilities. Exposure to CI/CD pipelines and source control systems (e.g., Git). Coordinate daily stand-ups and synchronize with teams across time zones; establish clear handoff and defect resolution workflows. Foster transparency, accountability, and continuous improvement across global QA teams. Education And Experience
Bachelor’s or Master’s degree in Computer Science, Biomedical Engineering, Electrical Engineering, or related field. 5+ years of experience in embedded software testing, including at least 2+ years in medical device software testing. Proven experience working with distributed QA teams, including offshore coordination and remote collaboration tools. Strong understanding of medical device regulations, including IEC 62304, ISO 14971, and FDA guidance. Exposure to CI/CD pipelines, Git, and DevOps practices is a plus. Additional Information
The position is hybrid at our Acton office. Travel is estimated at 0% but will flex depending on business needs. Note: This position is eligible for hybrid working arrangements and requires on-site work from an Insulet office.
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Insulet is seeking a self-motivated, highly skilled and detail-oriented
Senior Software Test Engineer
to lead testing efforts for embedded software systems in
regulated medical devices . This role involves designing and executing both manual and automated test strategies to ensure compliance, safety, and performance of embedded applications across various platforms. The ideal candidate will also have experience collaborating with
onshore and offshore QA teams
to drive global test execution and quality alignment. This position supports software quality assurance efforts related to new product development and product modifications for the Research and Development group, ensuring new products are verified and validated prior to release for shipment and that designs meet user needs and requirements. Software QA efforts are lifecycle-oriented from requirements development through the product lifecycle. This role will also be involved in validating software development tools to improve overall quality, including peer reviews, software hazard analysis, requirements traceability, software code analysis, defect tracking, software metrics, configuration management, test automation using an existing framework, and software tool validations. Responsibilities
Develop and maintain manual and automated test cases for embedded software. Perform functional, regression, performance, stress, and reliability testing. Ensure compliance with industry standards and internal quality benchmarks. Maintain detailed documentation of test plans, procedures, and results. Software requirement analysis, architectural and design specification reviews, and creating use cases. Identify and fill gaps in use case/test case. Create and execute test plans, test designs, and test cases; generate test reports. Create and update trace matrices between requirements and tests. Work closely with the software development team to identify improvements and maximize testability. Oversee development of test objects to meet protocol needs and extend protocols/plans as device features evolve. Participate in product design reviews and Agile/Scrum ceremonies. Mentor junior QA engineers and contribute to continuous improvement of QA processes. Coordinate with onshore and offshore teams using Jira, Confluence, Slack, and Teams; establish handoff protocols and defect resolution workflows across time zones. Required Skills And Competencies
5+ years of experience in embedded software testing, with a strong mix of manual and automation experience; at least 2+ years in medical device software testing. Familiarity with SDLC, test lifecycle, and Agile methodologies. Proficiency in Python, Jenkins, and test automation tools. Experience with products from prototype through 510(k)/ISO clearance and commercialization is preferred. Strong understanding of software quality assurance principles, practices, and metrics; knowledge of software development and testing best practices. Hands-on experience with modern software development and QA tools. Proven track record developing and executing software test protocols for complex medical devices. Document test protocols, procedures, and results in accordance with DHF and quality system documentation. Familiarity with IEC 62304, ISO 14971, FDA 21 CFR Part 820 and related medical device software standards. Strong analytical and problem-solving skills; excellent communication and documentation abilities. Exposure to CI/CD pipelines and source control systems (e.g., Git). Coordinate daily stand-ups and synchronize with teams across time zones; establish clear handoff and defect resolution workflows. Foster transparency, accountability, and continuous improvement across global QA teams. Education And Experience
Bachelor’s or Master’s degree in Computer Science, Biomedical Engineering, Electrical Engineering, or related field. 5+ years of experience in embedded software testing, including at least 2+ years in medical device software testing. Proven experience working with distributed QA teams, including offshore coordination and remote collaboration tools. Strong understanding of medical device regulations, including IEC 62304, ISO 14971, and FDA guidance. Exposure to CI/CD pipelines, Git, and DevOps practices is a plus. Additional Information
The position is hybrid at our Acton office. Travel is estimated at 0% but will flex depending on business needs. Note: This position is eligible for hybrid working arrangements and requires on-site work from an Insulet office.
#J-18808-Ljbffr