Principal Design Quality Engineer

We are looking for an experienced Design Quality Engineer to join our team in Irvine, CA! At Nidus Biomedical, we’re focused on improving patients’ lives with creativity, collaboration, and cutting-edge technology. We’re a team of passionate engineers and visionaries dedicated to incubating breakthrough ideas into medtech startup companies. If you’re looking to make a real impact in the world of healthcare while enjoying a fast-paced and innovative work environment, we want you to join us!

Roles and Responsibilities:

• Reviewing and approving design verification and validation test plans, protocols and reports
• Establish and maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications)
• Able to lead and drive 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's use errors are minimized or mitigated through standardized approach
• Establish and participate in supplier qualification/development activities to ensure that products meet design and manufacturing requirements
• Actively promote and participate in a cross-functional teamwork environment
• Ensuring development activities are planned, documented, and executed to satisfy regulatory, customer and designated internal requirements

Qualifications

• 8 - 10 Years experience in medical devices with BS in Mechanical / Biomedical Engineering or related discipline or equivalent combination of education and experience
• Previous transcatheter medical device experience preferred
• Expertise in medical device standards such as ISO 13485, ISO 14971, and 21 CFR 820

Nidus Biomedical offers a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k).