Staff Software Design Quality Engineer

$102.6k - $171k

Stryker Orthopaedics

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)

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Vacancy posted 10 days ago

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