Insulet Corporation
Senior Software Test Engineer - (Hybrid)
Insulet Corporation, Acton, Massachusetts, us, 01720
Senior Software Test Engineer Embedded Software (Manual & Automation, Medical Devices)
Insulet started in 2000 driven to achieve our mission of enabling our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod product platform. In the last two decades we have improved the lives of hundreds of thousands of patients who have insulin-requiring diabetes by using innovative technology that is wearable, waterproof, and lifestyle accommodating. We are on an exciting trajectory of significant growth and global expansion enabling us to reach more patients around the globe. Insulet is seeking for a self-motivated a 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 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, software test automation using existing automation 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. Identifying and filling gaps in Use Cases/Test Cases. 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. Mentor junior QA engineers and contribute to continuous improvement of QA processes. Participate in Agile/Scrum ceremonies and contribute to sprint planning and retrospectives. Required Leadership/Interpersonal Skills & Behaviors: Self-motivated Results-driven with 'can-do attitude' Proactive Quick learner Required Skills and Competencies: 5+ years of experience in embedded software testing, with a strong mix of manual and automation, with 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 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 Document test protocols, procedures, and results in accordance with design history file (DHF) and quality system documentation. Familiarity with IEC 62304, ISO 14971, FDA 21 CFR Part 820 standards, regulations and international standards applicable to medical device software development, verification and validation a plus. Strong analytical and problem-solving skills. Excellent communication and documentation abilities. Exposure to CI/CD pipelines and source control systems like Git. Coordinate daily stand-ups and syncs across onshore and offshore teams using tools like Jira, Confluence, Slack, and Teams. Establish clear handoff protocols, test ownership, and defect resolution workflows across time zones. Foster a culture of 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, with 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. Why Join Us? Work on cutting-edge embedded technologies. Direct impact on patient safety and healthcare innovation. Be part of a collaborative and innovative engineering team. Competitive compensation and benefits. Opportunities for professional growth and leadership. The US base salary range for this full-time position is $94,725.00 - $142,087.50. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the primary work location in the US. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your Talent Acquisition Specialist can share more about the specific salary range for your preferred location during the hiring process. Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits.
Insulet started in 2000 driven to achieve our mission of enabling our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod product platform. In the last two decades we have improved the lives of hundreds of thousands of patients who have insulin-requiring diabetes by using innovative technology that is wearable, waterproof, and lifestyle accommodating. We are on an exciting trajectory of significant growth and global expansion enabling us to reach more patients around the globe. Insulet is seeking for a self-motivated a 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 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, software test automation using existing automation 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. Identifying and filling gaps in Use Cases/Test Cases. 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. Mentor junior QA engineers and contribute to continuous improvement of QA processes. Participate in Agile/Scrum ceremonies and contribute to sprint planning and retrospectives. Required Leadership/Interpersonal Skills & Behaviors: Self-motivated Results-driven with 'can-do attitude' Proactive Quick learner Required Skills and Competencies: 5+ years of experience in embedded software testing, with a strong mix of manual and automation, with 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 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 Document test protocols, procedures, and results in accordance with design history file (DHF) and quality system documentation. Familiarity with IEC 62304, ISO 14971, FDA 21 CFR Part 820 standards, regulations and international standards applicable to medical device software development, verification and validation a plus. Strong analytical and problem-solving skills. Excellent communication and documentation abilities. Exposure to CI/CD pipelines and source control systems like Git. Coordinate daily stand-ups and syncs across onshore and offshore teams using tools like Jira, Confluence, Slack, and Teams. Establish clear handoff protocols, test ownership, and defect resolution workflows across time zones. Foster a culture of 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, with 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. Why Join Us? Work on cutting-edge embedded technologies. Direct impact on patient safety and healthcare innovation. Be part of a collaborative and innovative engineering team. Competitive compensation and benefits. Opportunities for professional growth and leadership. The US base salary range for this full-time position is $94,725.00 - $142,087.50. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the primary work location in the US. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your Talent Acquisition Specialist can share more about the specific salary range for your preferred location during the hiring process. Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits.