Senior Design Quality Engineer — Medical Devices (Hybrid)

Stryker Corporation; Fremont (CA); Hybrid; USD 82,000 - 136,000; Full time

Job summary

Stryker Corporation in Fremont, CA (and Salt Lake City, UT) invites a Senior Design Quality Engineer to join the Neurovascular division. You will drive product risk management, post-market surveillance, design control and continuous quality improvement across the lifecycle.

This role involves applying statistical analysis, leading investigations, developing tests, and collaborating with engineering, regulatory, manufacturing, and quality teams to ensure safety, performance, and compliance of NV

Qualifications

• Bachelor’s degree in Engineering or related technical field.
• 2+ years in engineering, quality engineering, or related role.
• Experience with structured problem-solving and quality tools.
• Experience with product testing, validation, risk management, or process improvement.
• Experience in medical devices or regulated industry preferred.
• Knowledge of design controls and quality systems.
• Experience with statistical analysis and validation activities.

Responsibilities

• Develop qualification plans, protocols, and reports for products and components.
• Execute testing, inspection, verification, and validation activities.
• Perform failure investigations and root cause analyses.
• Maintain product risk management documentation throughout the lifecycle.
• Conduct risk assessments and support design reviews per quality requirements.
• Apply statistical methods to support tests and investigations.
• Collaborate with engineering, regulatory, manufacturing, and quality teams.

Skills

Quality engineering

Problem solving

Statistical analysis

Risk management

Design controls

Product testing

Education

Bachelor’s degree in Engineering

Tools

FMEA

CAPA

Job description

Stryker Corporation in Fremont, CA (and Salt Lake City, UT) invites a Senior Design Quality Engineer to join the Neurovascular division. You will drive product risk management, post-market surveillance, design control and continuous quality improvement across the lifecycle.

This role involves applying statistical analysis, leading investigations, developing tests, and collaborating with engineering, regulatory, manufacturing, and quality teams to ensure safety, performance, and compliance of NV