Director-Design Quality Engineering-Ultrasound
Location
Bothell, WA
Level
Manager / Director
Department
MedTech
Type
Salary
$161,000 - $275,000
Job Description
Posted on:
2025-11-12
Responsibilities
- Lead and develop the Ultrasound Design Quality organization.
- Ensure compliance with design control requirements and applicable standards.
- Drive a culture of quality to meet safety, reliability, and efficacy requirements.
- Partner with R&D, Product Management, and other functions for product safety and reliability.
- Oversee risk management and design-related activities during product lifecycle.
- Engage with FDA and other regulators during inspections and audits.
- Translate complex designs into regulatory-ready documentation.
Job Requirements
- Minimum of 10+ years in Design Quality Engineering/Risk management for FDA regulated Medical Devices.
- At least 5+ years in leadership roles within Design Quality Engineering.
- Experience with FDA inspections and audits.
- Proficiency in statistical techniques and design of experiments.
- Bachelor’s Degree in Engineering, Quality, Regulatory or related fields.
- Ability to meet physical, cognitive, and environmental job requirements.
- Willingness to work in-office at least 3 days a week.
