Senior Quality Engineer – Medical Devices, Design Assurance

Willow Innovations; Mountain View (CA); Hybrid; USD 180,000 - 200,000; Full time

Job summary

A leading health technology company in Mountain View, CA, is seeking a Senior Quality Engineer to implement and maintain quality systems for medical devices and consumer products. This hybrid role involves ensuring compliance with design control requirements, developing verification and validation plans, and collaborating with cross-functional teams. The ideal candidate will have over 10 years of experience in medical device quality engineering, strong regulatory knowledge, and excellent analytical skills. The salary range for this position is $180,000–$200,000/year.

Qualifications

• Minimum 10 years in medical device quality engineering with a focus on design assurance.
• Strong understanding of regulatory standards including ISO 13485 and FDA regulations.
• Proficiency in risk management tools such as FMEA and statistical methods.

Responsibilities

• Drive Design Assurance in Product Development.
• Develop and Execute Verification & Validation (V&V) Plans.
• Ensure Compliance with Regulatory & Quality Standards.
• Support Design Transfer & Manufacturing Readiness.
• Drive Continuous Improvement in Quality Systems.

Skills

Analytical skills

Problem-solving

Cross-functional collaboration

Education

Bachelor's degree in Engineering

Tools

Minitab

Tableau

Quality Management Systems (QMS)

Job description

A leading health technology company in Mountain View, CA, is seeking a Senior Quality Engineer to implement and maintain quality systems for medical devices and consumer products. This hybrid role involves ensuring compliance with design control requirements, developing verification and validation plans, and collaborating with cross-functional teams. The ideal candidate will have over 10 years of experience in medical device quality engineering, strong regulatory knowledge, and excellent analytical skills. The salary range for this position is $180,000–$200,000/year.