• Senior Systems Test Engineer

    Insight Global (San Diego, CA)


    Job Description

    This role will support a global, mission-driven medical technology company developing cloud-connected, software-driven products that integrate with mobile applications and data platforms in a highly regulated environment. The Senior Systems Test Engineer will lead the definition, analysis, and management of software and system requirements for cloud-integrated solutions, partnering closely with product, software engineering, quality, and regulatory teams. This individual will translate user needs and product requirements into clear, testable software and system requirements, maintain end-to-end traceability, and ensure design outputs meet regulatory and quality standards. The role is hands-off from a coding perspective and instead focuses on requirements development, technical reviews, risk management, and alignment across cross-functional stakeholders to support compliant, scalable cloud-enabled products.

     

    We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to [email protected] learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

    Skills and Requirements

    • 7+ years experience in software and/or systems requirements engineering, including translating user needs into system and software requirements

    • 5+ years of hands-on experience working with cloud-integrated products, with a solid understanding of APIs, databases, and system integrations

    • Background working in regulated environments with formal design controls, documentation, and traceability (medical device, life sciences, or similar)

    • Experience using PLM and/or ALM tools for requirements management, traceability, and version control

    • Ability to lead technical requirements reviews and collaborate effectively with product, software engineering, QA, and regulatory teams

    • Strong written communication skills with the ability to produce clear, testable, and auditable documentation • Experience supporting FDA-regulated products and familiarity with standards such as ISO 13485, IEC 62304, or FDA design controls

    • Exposure to cloud-connected mobile applications or IoT-enabled ecosystems

    • Prior experience working on healthcare, medical device, or digital health products

    • Experience supporting tool transitions or process improvements within requirements or systems engineering environments