Senior Quality Engineer – Neurovascular (Hybrid, Fremont)

Stryker; Fremont (CA); Hybrid; USD 101,000 - 168,000; Full time

Job summary

Stryker in Fremont, CA is hiring a Senior Design Quality Engineer to join the Neurovascular division in a hybrid role. You will lead product risk management, post-market surveillance, and design control activities across the lifecycle, driving quality improvements and robust investigations.

In this role you will develop qualification plans, perform validation, conduct risk assessments, and collaborate with regulatory, manufacturing, and engineering teams to ensure safety, performance, and

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 and existing products.
• Execute product testing, inspection, verification, and validation activities.
• Perform failure investigations and root cause analyses.
• Create, maintain, and update product risk management documentation.
• Conduct risk assessments and support design reviews.
• Apply statistical methods to support test method development and investigations.
• Analyze specifications and data to recommend product quality improvements.
• Collaborate with engineering, regulatory, manufacturing, and quality teams.

Skills

Structured problem-solving

Quality engineering

Risk management

Statistical analysis

Education

Bachelor’s degree in Engineering

Job description

Stryker in Fremont, CA is hiring a Senior Design Quality Engineer to join the Neurovascular division in a hybrid role. You will lead product risk management, post-market surveillance, and design control activities across the lifecycle, driving quality improvements and robust investigations.

In this role you will develop qualification plans, perform validation, conduct risk assessments, and collaborate with regulatory, manufacturing, and engineering teams to ensure safety, performance, and