Senior Design Quality Engineer - Risk & Validation Lead

Stryker; Salt Lake City (UT); Hybrid; USD 82,000 - 168,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Employee Stock Purchase Plan

Short-term disability

Dental insurance

Vision insurance

Wellbeing program

Job summary

Stryker is seeking a Senior Quality Engineer for its Neurovascular division. The role is hybrid and based in Fremont, CA or Salt Lake City, UT. You will drive product risk management, post-market surveillance, and design control activities throughout the lifecycle of NV products.

You will lead qualification efforts, perform analyses, and collaborate with multiple teams to ensure safety, compliance, and ongoing quality improvements in a fast-paced environment.

Qualifications

• Bachelor’s degree in Engineering or a related technical discipline.
• Minimum 2 years of experience in engineering, quality engineering, manufacturing engineering, or a related technical role.
• Experience using structured problem-solving methodologies and quality improvement tools.
• Experience supporting product testing, validation, verification, risk management, or process improvement activities.

Responsibilities

• Develop qualification plans, protocols, and reports for new products, existing products, components, and subassemblies.
• Execute product testing, inspection, verification, and validation activities to support design and quality objectives.
• Perform failure investigations and root cause analyses to identify product and process improvement opportunities.
• Create, maintain, and update product risk management documentation throughout the product lifecycle.
• Conduct risk assessments and support design reviews in accordance with quality system and design control requirements.
• Apply statistical methods and problem-solving tools to support test method development, validation activities, and engineering investigations.
• Analyze specifications, test results, and data to recommend revisions for quality and performance improvements.
• Collaborate with engineering, regulatory, manufacturing, and quality teams to support product development, design changes, and compliance activities.

Skills

Problem solving

Statistical analysis

Risk management

Design control

Product testing

Verification & validation

Root cause analysis

Education

Bachelor’s degree in Engineering

Job description

Stryker is seeking a Senior Quality Engineer for its Neurovascular division. The role is hybrid and based in Fremont, CA or Salt Lake City, UT. You will drive product risk management, post-market surveillance, and design control activities throughout the lifecycle of NV products.

You will lead qualification efforts, perform analyses, and collaborate with multiple teams to ensure safety, compliance, and ongoing quality improvements in a fast-paced environment.