Software Development Engineer

The Senior Software Development Engineer in Test is a coding-focused individual contributor responsible for verification and validation (V&V) of embedded software used in insulin-pump systems. This role develops and maintains automated test software, reusable libraries, frameworks, and CI/CD integrations while executing risk-based testing across firmware, embedded applications, device interfaces, hardware/software integration, and supporting test infrastructure. The engineer partners closely with software, systems, hardware, quality, and regulatory teams to build high-confidence evidence that product requirements are met and patient safety is protected.

Responsibilities may include the following and other duties may be assigned.

Test Automation & Engineering Tools

• Design, develop, version, and maintain production-quality automated test scripts, test library functions, framework APIs, utilities, and test data using Python and JavaScript.
• Write clean, maintainable, and well-structured test software for embedded-device workflows including device configuration, communication interfaces, logging, data capture, and result analysis.
• Integrate, troubleshoot, and maintain automated tests in source control and CI/CD pipelines, including test execution, quality gates, reporting, and failure diagnostics.
• Debug test scripts, framework libraries, CI/CD failures, and test-environment issues; identify root causes and implement durable corrective fixes.

AI-Enabled Quality Engineering

• Apply AI-assisted tools responsibly to improve requirements analysis, test design, test-data generation, log analysis, defect triage, and test documentation.
• Evaluate AI-enabled testing capabilities for accuracy, traceability, security, intended use, and fit within a regulated medical-device development environment.
• Use engineering judgment to review AI-generated outputs and ensure that test evidence remains accurate, reproducible, and compliant with established quality processes.

Embedded Pump Software Verification & Validation

• Develop and execute test strategies, test plans, protocols, test cases, and reports for embedded pump firmware.
• Analyze software and system requirements, architecture, interfaces, and risk controls to identify test conditions, gaps, and traceable verification evidence.
• Perform functional, integration, regression, reliability, fault-injection, and recovery testing of embedded device behavior.
• Validate hardware/software interactions using hardware-in-the-loop (HIL) and software-in-the-loop (SIL) benches, simulators, test fixtures, and laboratory equipment.
• Investigate defects, isolate root causes, document reproducible evidence, and partner with development teams through resolution and verification.

Quality, Risk & Regulatory Compliance

• Create and maintain objective V&V evidence, including traceability between requirements, risks, tests, results, deviations, and defects.
• Execute risk-based testing in accordance with design controls, applicable procedures, and relevant medical-device standards, including IEC 62304, ISO 13485, and risk-management processes.
• Support design reviews, risk analyses, audits, investigations, CAPAs, and release-readiness activities as needed.
• Identify quality risks and opportunities to improve test coverage, product reliability, and engineering processes.

Cross-Functional Collaboration & Technical Leadership

• Collaborate with Systems Engineering, Embedded Software, Hardware, Quality, Regulatory, Cybersecurity, and Manufacturing teams throughout the product lifecycle.
• Communicate test status, quality risks, defects, and recommendations clearly to technical and cross-functional stakeholders.
• Provide technical guidance and mentorship to test engineers, share automation and embedded-test practices, and contribute as a senior member of the team.

Requires a bachelor’s degree and minimum of 4 years of relevant experience, or an advanced degree with a minimum of 2 years of relevant experience., * Bachelor’s degree in Computer Science, Software Engineering, Electrical Engineering, Biomedical Engineering, or a related technical discipline.

• Experience testing embedded software, firmware, real-time systems, or hardware/software integrated products; medical-device experience is strongly preferred.
• Strong hands-on programming proficiency in Python and JavaScript, including code design, debugging, refactoring, use of version control, and development of reusable functions and libraries.
• Hands-on experience with embedded debugging and test tools such as HIL systems, simulators, test fixtures, serial interfaces, protocol analyzers, device logs, or laboratory instruments.
• Demonstrated hands-on software development experience building and maintaining automated test frameworks, reusable libraries, and utilities; ability to debug and resolve issues in test code independently.
• Experience integrating automated tests into CI/CD workflows, including pipeline configuration, test execution, quality gates, reporting, and diagnosis of pipeline failures.
• Experience with AI-enabled testing or AI-assisted engineering workflows, including the ability to evaluate output quality, maintain appropriate traceability and human review, and apply generated code responsibly.
• Working knowledge of verification and validation, requirements traceability, risk-based testing, defect investigation, and root-cause analysis in a regulated environment.
• Experience with device communication protocols, wireless connectivity, or embedded interfaces is preferred.

• Experience with Appium is a plus for occasional companion-application or system-workflow automation; it is not a primary responsibility of this embedded pump-testing role. Strong written and verbal communication, analytical problem-solving, and collaboration skills.

• Experience with Arduino and/or Raspberry Pi boards for embedded test.

MiniMed offers a competitive salary and flexible benefits package

At MiniMed, we put people first. A commitment to our employees lives at the core of our values: We recognize their contributions. They share in the success they help create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every stage of your career and life. Salary ranges for U.S (excl. PR) locations (USD):$124,000 - $212,000

For roles located in California, Seattle WA, Washington DC, Boston MA, and New York City, the salary range is $124,000.00 - $212,000.00 USD.

Actual compensation may vary based on factors including experience, education, certifications, skills, market conditions, internal equity, and geographic location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

At MiniMed, we are committed to supporting the well-being and financial security of our employees. Regular employees working 20 or more hours per week are eligible for a robust benefits package, including health, dental, and vision insurance, as well as access to a Health Savings Account, Healthcare Flexible Spending Account, life insurance, long-term disability leave, and a dependent daycare spending account. In addition, all regular employees enjoy incentive plans, a 401(k) plan with company match, short-term disability coverage, paid time off and holidays, participation in our Employee Stock Purchase Plan, and access to our Employee Assistance Program. Eligible employees may also benefit from our Non-qualified Retirement Plan Supplement and Capital Accumulation Plan, subject to IRS minimum earnings requirements. Please note that “regular employees” refers to those who are not temporary staff, such as interns, and some benefits may not apply to employees in Puerto Rico.

For further details about our comprehensive benefits, we encourage you to visit the link below.

At MiniMed, you can begin a lifelong career of exploration and innovation, while helping make a difference in the lives of people living with diabetes around the globe. You’ll lead with purpose, breaking down barriers to innovation for a more connected, compassionate world., MiniMed is a full-stack insulin delivery company dedicated to supporting people living with diabetes through every step of their journey - when and how they need it. For more than 40 years, we’ve been committed to redefining what’s possible: intelligent dosing systems designed for real life, predictive insights that stay a step ahead, and always on support when it’s needed most. At the heart of everything we do is a simple Mission: to make every day a better day for people with diabetes.