Staff Software Design Quality Engineer
$102.6k - $222.3kStryker
Stryker seeks a Staff Software Design Quality Engineer to oversee software quality and regulatory compliance for connected healthcare solutions. This strategic role integrates quality systems, risk management, and compliance throughout the software development lifecycle, partnering with engineering and regulatory teams across multiple locations.
Responsibilities
- Lead software quality and compliance activities for cloud-based, connected, and SaaS medical technologies
- Conduct risk assessments, FMEAs, security reviews, and change-impact assessments during product development
- Review quality deliverables and design documentation for compliance with regulatory requirements
- Develop and improve quality procedures, templates, and governance frameworks for scalable software practices
- Support audit readiness through evidence collection, gap assessments, and corrective action management
Requirements
- Bachelor's degree in Engineering, Sciences, or related technical discipline
- Minimum 4 years in regulated industry R&D, Quality, Software Engineering, or Healthcare IT
- Experience with software development lifecycle methodologies including Agile, SAFe, and Waterfall
- Demonstrated expertise in software risk management, FMEA, security assessments, and defect management
- Master's degree in Computer Engineering, Software Engineering, or related field (preferred)
- Experience with Software as a Medical Device (SaMD) or regulated medical software products (preferred)
- Knowledge of FDA regulations, IEC 62304, IEC 82304, or medical device quality standards (preferred)
Compensation: $102,600–$222,300 USD Annual (based on location and pay band)
Vacancy posted 2 days ago
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