Design Quality Engineer

USA · Santa Barbara, California         ·         Full time

About Cognixion

Cognixion is an internationally award-winning neuroscience and technology company pioneering the field of Assisted Reality. Cognixion develops AI powered non-invasive BCI (Brain Computer Interface), assistive tech, and delightfully useful applications for people, including those affected by neurodevelopmental disorders and injuries to the brain and spinal cord. Based in Santa Barbara, California, the company develops software that helps people with communication challenges express themselves significantly faster than any other solution on the market and provides a direct non-verbal interface to control Alexa enabled devices around the home, school, and workplace. For more information, please visit https://cognixion.com.

We’re on a global mission. Join us as we transform the lives of millions of people, and design and develop some of the most advanced technology available. We want this to be your forever home, and the place where you will tell everyone that you’ve done the best work of your life.

Your role: Design Quality Engineer

Scope of Responsibilities

• Assures that new product designs and the processes for manufacturing them meet all regulatory and company requirements with respect to safety and efficacy.
• Audit Design History Files and Project History Files
• Partner with cross-functional Cognixion subject matter experts in the planning, execution, and monitoring of product development and associated design controls.
• Represent design quality on the project team, ensuring documentation is appropriate and complete.  Provide quality assurance oversight and guidance as needed.
• Maintain and develop relationships with Engineering to assist with the resolution of issues, escalating to the Product Quality Manager, when appropriate.
• Lead risk management reviews at applicable product development stages, and drive resulting mitigation actions, to assure Cognixion’s compliance with applicable medical device regulations and standards.
• Audit product traceability matrix to drive and confirm completion of all design outputs and verification and validation testing meets requirements and ties back to appropriate identified risks.
• Partner with Software Quality Assurance and Engineering for development of verification test plans.
• Assists with Internal Audits Planning and execution
• Assist with implementation of the company’s Quality Management System to identify gaps in compliance to regulations and best practices.
• Conduct and participate in Change Management and CAPA activities for the sustaining support of Cognixion products.
• Maintain Design History File (DHF) documentation as well as standard operating procedures and records related to the process.
• Interface with suppliers for design, development, and continuous improvement.
• Participate in the hiring process of additional Quality team members.

Our Ideal Candidate brings:

• Bachelor’s degree, preferably in a science field.
• 3+ years’ experience working in the regulated life science industry. Design and/or software quality-specific experience preferred.
• Understanding of GMP/Quality Management Systems requirements relevant to the medical device industry, including 21 CFR 820, ISO 13485:2016, EU MDR
• Certification in Quality Engineering and/or Quality Auditing, e.g. ASQ QA, QE, or ISO-13485 lead auditor an asset
• Technical writing and detailed documentation capability
• Strong analytical skills with the ability to extract meaningful information, conclusions, and direction from complex data sets.
• Highly skilled in the use of MS Word, Excel, PowerPoint, and Visio. Experienced working in a MS SharePoint and Teams environment.
• Willingness to travel periodically to our Toronto, Canada, Santa Barbara CA office sites and/or design and manufacturing consultant sites.

Job Type: Full-time Employee

Job Benefits:

• Central downtown location with easy access to transit, dining, entertainment
• Work in a friendly and very team-oriented, collaborative culture
• Opportunities to see your work directly making a social impact in the world
• Flexible mobile working arrangements available for high performers
• Incentive Stock Options Plan for high performers
• Growing business with offices in Canada and USA
• International Travel opportunities

Please click here to apply.