Senior Quality Engineer, Neurovascular Risk & Design Hybrid

Stryker; Colorado; Hybrid; USD 101,000 - 168,000; Full time

Job summary

Stryker is hiring a Senior Design Quality Engineer to join our Neurovascular division. This hybrid/onsite role is based in Fremont, CA, and will focus on product risk management, post-market surveillance, and compliance with design controls throughout the lifecycle.

You will lead risk management, implement quality improvements, and collaborate across engineering, regulatory, manufacturing, and quality teams to ensure device safety and performance.

Qualifications

• Bachelor's degree in Engineering or 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 applicable 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 process data, and recommend revisions to improve product quality and performance.
• Collaborate with engineering, regulatory, manufacturing, and quality teams to support product development, design changes, and compliance activities.

Skills

Structured problem-solving

Quality engineering

Product risk management

Statistical analysis

Education

Bachelor's degree in Engineering or related technical discipline

Job description

Stryker is hiring a Senior Design Quality Engineer to join our Neurovascular division. This hybrid/onsite role is based in Fremont, CA, and will focus on product risk management, post-market surveillance, and compliance with design controls throughout the lifecycle.

You will lead risk management, implement quality improvements, and collaborate across engineering, regulatory, manufacturing, and quality teams to ensure device safety and performance.