Principal Test Engineer/Test Lead

The Principal Test Engineer/Test Lead is a recognized technical leader responsible for defining and driving quality engineering strategy, verification & validation (V&V), test automation, AI-enabled testing, and release readiness across complex connected medical device ecosystems. This role leads end-to-end quality initiatives spanning mobile applications, connected medical devices, cloud services, APIs, cybersecurity, and integrated system workflows while ensuring compliance with global regulatory and quality standards.

In addition to deep technical expertise, this position provides leadership and coordination of globally distributed and offshore testing teams, ensuring successful execution of testing activities across multiple programs, releases, and product portfolios. The Principal Test Engineer acts as a trusted advisor to engineering and business leadership, driving innovation, quality excellence, and continuous improvement throughout the product lifecycle.

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

Technical Leadership & Test Strategy

• Define and drive the overall test strategy, quality roadmap, and release readiness activities across multiple products and programs.
• Serve as the technical authority and subject matter expert (SME) for software, systems, integration, connectivity, and end-to-end testing activities.
• Establish quality engineering best practices, testing standards, and governance models across teams.
• Influence product quality decisions through data-driven analysis, risk assessments, and engineering leadership.
• Lead technical reviews of requirements, architecture, design, risk analysis, and testability assessments.
• Drive organizational improvements in quality engineering processes, methodologies, and testing effectiveness.

Mobile & Connected Medical Device Testing

• Lead testing activities for mobile applications across Android and iOS platforms.
• Define and execute validation strategies for connected medical devices and digital health ecosystems.
• Oversee Bluetooth Low Energy (BLE) communication testing, including pairing, connectivity, synchronization, recovery, failover, and interoperability scenarios.
• Ensure end-to-end testing coverage across hardware, firmware, mobile applications, cloud services, APIs, and external integrations.
• Validate usability, performance, reliability, compatibility, scalability, and customer workflows across supported platforms.

Verification, Validation & Regulatory Compliance

• Lead Verification & Validation (V&V) activities throughout the product development lifecycle.
• Develop test strategies, test plans, test protocols, traceability matrices, and test reports.
• Ensure compliance with Design Controls and applicable regulatory requirements, including: FDA regulations IEC 62304 ISO 13485 Risk Management processes Cybersecurity and Privacy requirements
• Support audits, inspections, CAPAs, field actions, and regulatory submissions.
• Ensure complete traceability from requirements through verification evidence and product release.

Cloud, API & Systems Integration Testing

• Lead cloud services validation and API integration testing activities.
• Ensure secure and reliable interoperability across distributed systems and enterprise platforms.
• Define test coverage for data integrity, synchronization, fault tolerance, resiliency, and disaster recovery scenarios.
• Collaborate with architecture and development teams to validate complex system integrations and customer workflows.

Test Automation & CI/CD Excellence

• Define and execute organizational automation strategies across mobile, cloud, API, and system testing domains.
• Lead development and expansion of test automation frameworks utilizing tools such as: Appium Selenium API Automation Frameworks CI/CD-integrated testing solutions
• Establish automated quality gates and release validation processes.
• Drive continuous testing initiatives throughout the software development lifecycle.
• Improve testing efficiency, coverage, repeatability, and release confidence through automation.

AI-Driven Quality Engineering

• Drive adoption of AI-enabled testing technologies and intelligent quality engineering practices.
• Leverage Generative AI and AI-assisted tools to: Generate and optimize test cases Improve requirements analysis Enhance defect triage Accelerate test design activities Improve documentation quality
• Implement predictive quality analytics and risk-based test prioritization using AI-driven insights.
• Evaluate emerging AI technologies and recommend innovative solutions that improve engineering productivity and product quality.
• Establish governance and best practices for responsible use of AI within regulated medical device development environments.
• Champion quality engineering transformation initiatives through intelligent automation and data-driven decision making.

Product Quality, Risk Management & Field Investigation

• Lead risk-based testing strategies across all phases of product development.
• Drive identification, prioritization, and mitigation of product quality risks.
• Lead critical defect investigations and complex root-cause analysis activities.
• Support post-market surveillance, customer escalations, and field issue investigations.
• Analyze operational metrics, field performance data, customer feedback, and quality trends to identify opportunities for continuous improvement.
• Drive implementation of corrective and preventive actions (CAPA) to improve product reliability and customer outcomes.

Global Test Leadership & Delivery Management

• Lead and coordinate testing activities across geographically distributed and offshore engineering teams.
• Define project priorities, testing scope, milestones, and resource allocation strategies.
• Delegate work, provide technical direction, and ensure effective execution of planned testing activities.
• Establish consistent testing standards, reporting mechanisms, and quality processes across global teams.
• Monitor progress, identify delivery risks, and drive issue resolution to ensure project commitments are met.
• Partner with external vendors, contractors, and offshore delivery organizations to ensure alignment with quality and business objectives.
• Provide executive-level status reporting, risk assessments, quality metrics, and release recommendations.

Cross-Functional Collaboration & Organizational Influence

• Partner with Systems Engineering, Software Development, Firmware Engineering, Product Management, Quality, Regulatory, Clinical, Cybersecurity, Operations, and Business stakeholders.
• Lead quality discussions during planning, design reviews, release reviews, and governance meetings.
• Act as the primary testing representative for major programs and strategic initiatives.
• Influence engineering practices, technical decisions, and organizational quality strategies.
• Represent the organization during customer engagements, audits, regulatory inspections, and executive reviews.

Mentorship & Talent Development

• Mentor and coach engineers across multiple levels and disciplines.
• Promote technical excellence, innovation, and continuous learning across teams.
• Support workforce development through training, knowledge sharing, and leadership initiatives.
• Foster collaboration across globally distributed engineering organizations.

Requires a bachelor’s degree and minimum of 10 years of relevant experience or advanced degree with a minimum of 8 years of relevant experience., * Bachelor’s degree in Engineering, Computer Science, Software Engineering, or related technical discipline.

• 10+ years of experience in software testing, systems testing, quality engineering, or medical device product development.
• Demonstrated experience leading large-scale testing efforts across complex software, mobile, cloud, and connected device ecosystems.
• Experience managing or leading globally distributed and offshore test teams.
• Strong knowledge of: Mobile testing (Android/iOS) API and Cloud testing BLE and connected device validation Test automation frameworks CI/CD pipelines Verification & Validation methodologies Risk-based testing Defect management and root-cause analysis
• Experience operating within regulated environments and quality management systems.
• Experience in connected medical devices, digital health, or regulated healthcare software.
• Expertise in AI-enabled quality engineering and intelligent test automation.
• Familiarity with cybersecurity validation and privacy compliance.
• Advanced knowledge of Agile, DevOps, and continuous delivery practices.
• Experience leading enterprise quality transformation initiatives.

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):$109,000.00 - $185,000.00

For roles located in California, Seattle WA, Washington DC, Boston MA, and New York City, the salary range is $121,000.00 - $205,000.00 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).

This position is eligible for a short-term incentive called the Short Term Incentive (STI).

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.