Senior SW Design Quality Engineer

This is a fully remote position, open to applicants in United States.

📋 Description

• Deliver technical support and expertise to Software teams to guarantee adherence to software development protocols and relevant safety and quality regulations and standards.

• Act as a key member of the R&D Quality Assurance Engineering team, facilitating software design assurance for cloud-based, data platforms, and AI/ML-enabled systems.

• Advise cross-functional teams on IEC 62304, 21 CFR 820, and international regulations pertinent to SaaS, data, and AI-driven products.

• Oversee the application, compliance, and ongoing enhancement of software development and validation practices for distributed systems, cloud services, and data platforms.

• Lead pre-market risk management activities, encompassing Software Hazard Analysis, design FMEA, and risk control measures.

• Provide guidance to Software Design and Test teams regarding requirements traceability, software configuration management, tool validation, and cloud/data service integration.

• Evaluate and approve software design control deliverables related to cloud-hosted services, data pipelines, and AI/ML components.

• Assist with post-market activities involving software anomalies, model behavior, data quality challenges, risk assessments, and CAPA.

• Draft, review, and maintain Design History Files, SOPs, protocols, and reports.

• Analyze infrastructure, data, and model change controls for product impact and regulatory compliance.

• Relay plans, progress, risks, and design assurance factors to cross-functional teams and senior leadership.

⛳️ Requirements

• Bachelor’s degree in a technical field with 5–8 years of relevant experience, or a Master’s degree with 2–5 years of equivalent industry experience, or a PhD with 0–2 years of experience.

• Extensive experience in software design assurance for cloud-based, data platforms, API, and service-oriented systems within a regulated setting.

• Practical knowledge of IEC 62304, FDA 21 CFR Part 820, and ISO 13485.

• Capability to implement software design assurance principles throughout the SDLC, including requirements analysis, architecture and design evaluations, implementation oversight, integration, and verification.

• Experience in conducting and reviewing software risk management processes, including Software Hazard Analysis, design FMEA, and change impact evaluations.

• Proficiency in reviewing and approving software design control deliverables for traceability, risk control execution, and regulatory compliance.

• Background in supporting software configuration management, tool validation, and the integration of cloud services, data pipelines, and platform components.

• Ability to articulate design assurance, risk, and compliance issues to both technical teams and senior leadership.

• AI/ML experience or ASQ CSQE certification is preferred.

🏝️ Benefits

• A comprehensive and full benefits package.

• Opportunities for growth on a global scale.

• Access to career development through in-house training programs and/or qualified tuition reimbursement.

• An exciting and innovative organization at the forefront of the industry, dedicated to its employees, customers, and communities.

• Home office workplace arrangements.

• A hybrid working environment may be available for employees within commuting distance.

• Flexible workplace options.

• Reasonable accommodations for individuals with disabilities.