Senior SaMD Design Quality Engineer (Hybrid)

Stryker; San Jose (CA); Hybrid; USD 89,000 - 149,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Employee Stock Purchase Plan (ESPP)

Job summary

Stryker is hiring a Senior Software Design Quality Engineer to support Digital Health projects as a software quality assurance engineer for pre-market product development. The role is hybrid, requiring commuting to San Jose, CA or Orlando, FL, with in-office presence 3 days a week.

You will design software components, lead root-cause analyses, and ensure traceability to regulatory standards, collaborating across R&D, Quality, Regulatory, and Marketing to meet patient safety and product quality

Qualifications

• Bachelor’s degree in a science or engineering.
• Minimum of 2+ years of experience in R&D, Quality Engineering, Software Quality Engineering, IT or Systems Engineering.
• Experience in highly regulated industries with compliance standards (cGMP, GDP, or equivalent).

Responsibilities

• Design software components and system elements to meet requirements and quality standards.
• Lead analytical problem-solving and evaluate design options against constraints to drive robust solutions.
• Translate design inputs into engineering specifications and contribute to architecture and documentation.
• Develop software modules, provide estimates, and participate in design and code reviews for quality.
• Collaborate with R&D, Quality, Regulatory, and Marketing to align design decisions with strategy and user needs.
• Create and maintain Design History File elements with traceability and regulatory compliance.
• Stay informed about clinical workflows and customer needs to guide design and usability.
• Adapt to new tools and processes, showing initiative and prioritization with minimal supervision.

Education

Bachelor’s degree in a science or engineering

Bachelor’s degree in Computer Engineering, Electrical Engineering, Software Engineering, or Computer Science

Job description

Stryker is hiring a Senior Software Design Quality Engineer to support Digital Health projects as a software quality assurance engineer for pre-market product development. The role is hybrid, requiring commuting to San Jose, CA or Orlando, FL, with in-office presence 3 days a week.

You will design software components, lead root-cause analyses, and ensure traceability to regulatory standards, collaborating across R&D, Quality, Regulatory, and Marketing to meet patient safety and product quality