Principal Design Quality Engineer

Our client is seeking an experienced Principal Design Quality Engineer to join their team in Irvine, CA. This client is a team of passionate engineers and visionaries dedicated to incubating breakthrough ideas into medtech startup companies. They focus on improving patients’ lives through creativity, collaboration, and cutting-edge technology. If you’re looking to make a real impact in the world of healthcare while enjoying a fast-paced and innovative work environment, our client wants you to join them!

Roles and Responsibilities

• Review and approve design verification and validation test plans, protocols, and reports.

• Establish and maintain Design History Files and Design Input/Output documentation, such as Product and Component Specifications.

• Lead the creation of Risk Management documentation with relevant cross-functional teams.

• Lead test method validation for engineering and design verification testing.

• Support Human Factor studies to ensure device use errors are minimized or mitigated through a standardized approach.

• Establish and participate in supplier qualification and development activities to ensure products meet design and manufacturing requirements.

• Actively promote and participate in a cross-functional teamwork environment.

• Ensure development activities are planned, documented, and executed to satisfy regulatory, customer, and internal requirements.

Qualifications

• 8-10 years of experience in medical devices with a Bachelor of Science in Mechanical/Biomedical Engineering or a related discipline, or an equivalent combination of education and experience.

• Previous experience with transcatheter medical devices is preferred.

• Expertise in medical device standards such as ISO 13485, ISO 14971, and 21 CFR 820.