Sr Manager, Software Test Engineering

Company Overview

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. We are looking for highly motivated, performance driven individuals who want to be part of building our Center of Excellence and be at the forefront of our rapidly growing global footprint. We are looking to hire amazing people who are guided by shared values and desire to exceed customer expectations. Our continued success depends on it.

Position Overview

The Senior Software Test Manager leads the overall quality strategy and execution for software releases. This role manages multiple testing teams, drives test planning and automation initiatives, and ensures high quality, on time delivery of complex software products. The manager partners closely with engineering, product, and cross functional teams to align on release goals, mitigate risks, and maintain strong quality standards. Responsibilities include team leadership, process improvement, resource planning, and oversight of all testing activities across manual, automated, integration, and performance testing. Strong communication, technical depth, and strategic planning are essential.

Responsibilities

• Manage the software testing team and ensure Software verification is conducted in accordance with the FDA standards to deliver high quality software.
• Manage multiple teams of Manual/SDET test engineers.
• Manage Design Control and Software Test initiatives to develop appropriate Design History File documents for FDA Class II and Class III medical devices.
• Responsible for the generation, review and approval of design control documentation with primary focus on software test deliverables.
• Collaborate with Project Management to support and optimize the schedules.
• Support software development teams on the validation of software tools.
• Work with software, hardware, user experience, marketing, manufacturing, and quality assurance on generation, documentation, verification and validation of requirements.
• Lead the creation of necessary documentation to comply with regulatory requirements and industry best practices.
• Establish and maintain software test programs, processes, procedures and controls to ensure compliance with FDA regulations and established standards such as IEC 62304.
• Ensures compliance to IEC 62304, and FDA Guidance on Software Contained in a 510(k) Submission.
• Provide guidance and participate in software development activities including design and code reviews, requirements analysis and tracing, defect tracking and configuration management, review requirements, specifications, product design documents, validation protocols, test plans, test cases, and other documentation as required and provide timely feedback.
• Applies a good working knowledge of Software Development Life Cycle (IEC 62304), Design Controls (ISO 13485) and other regulatory requirements and agencies as it relates to software test activities in software development.
• 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 software test in the core team meetings.
• Creating and executing test plans, test designs and test cases and generating test reports.
• Creating and updating Trace matrices between requirements and Tests.
• Work with the scrum Master and product owners to prioritize or deprioritize the backlog.
• Keep track of the Testing board and tools inventory for the team.
• Performs other duties as required.

Required Leadership/Interpersonal Skills & Behaviors

• Self-motivated
• Proactive
• Quick learner
• Mentor
• Ability to represent the team cross functionally.
• Generate metrics for the team as required.

Required Skills and Competencies

• Bachelor's or master's degree in computer science, Engineering, or related field.
• 8–12+ years of experience in software testing, including 4+ years in a leadership or management role.
• Strong expertise in test automation frameworks, performance testing, and modern QA methodologies.
• Proven experience managing large, distributed, or cross functional testing teams.
• Excellent communication, stakeholder management, and decision making skills.
• Deep understanding of SDLC, Agile methodologies, and CI/CD pipelines.
• Experience with AI assisted testing tools is a strong plus.

Education and Experience

• BS in Software Engineering, Computer Science or similar field; 12+ years hands on experience in software testing in regulated industry and/or equivalent combination of education and experience.
• Experience of 2+ years being the Software Test Manager.
• Thorough understanding of software test 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 software test 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.
• Experience working with products from the prototype through 510(k)/ISO clearance and commercialization is preferred.

Additional Information

• The position is hybrid.
• Travel is estimated at 0% but will flex depending on business need.