Design Quality Engineer

TAE is the world’s first private fusion energy company, founded in 1998 to commercialize the cleanest, safest, most affordable, and sustainable form of carbon-free power. We are applying science and engineering to design transformational technologies. Whether it's harnessing fusion through the science of stars, making exponential leaps in power efficiency, or innovating medical care with a novel cancer treatment: We're turning the promise of science into reality. We’re looking for candidates who are passionate about realizing our mission: A future where all people have affordable access to reliable, abundant, and environmentally friendly fusion-generated electricity.

About the Role

• Trains to all Quality System documents assigned in the applicable training plan.
• Authors, updates, and maintains all Quality Management System documents concerning Design Controls.
• Represents the Quality function as needed in meetings concerning design controls.
• Maintains a working knowledge of all applicable international standards concerning design controls.
• Develops plans for verification, validation, and useability activities in accordance with standards and directives.
• Reviews all product-level, system and sub-system-level, and component-level requirements for completeness and testability.
• Creates test cases to validate product-level requirements and to verify system-level requirements. Also capable of creating test cases for lower level requirements when necessary.
• Creates protocols for assessing useability of applicable requirements.
• Maintains traceability of subject requirements to the test cases that verify or validate them.
• Executes test cases on appropriate systems and accurately records the results.
• Enters defects into a defect tracking system when a system deficiency is encountered, providing sufficient detail for a development engineer to recreate and address the defect.
• Prepares appropriate reports to summarize the results of all testing activities.
• Other duties assigned by leadership.

Requirements

• Bachelor's degree (BS) in technical or life science field.
• Minimum of 5-7 years of experience in a medical device quality system (i.e., ISO 13485, 21 CFR Part 820).
• Excellent writing skills including authoring and editing operating procedures, work instructions, test plans, test cases/protocols, and test reports.
• Strong analytical and problem-solving skills, demonstrating sound judgment and understanding of strategic context with excellent attention to detail.
• Experience interacting and supporting cross-functional teams to achieve successful outcomes.
• Expertise in MS Office Suite.
• Results-oriented, positive “can-do” attitude with demonstration of appropriate urgency and initiative.
• Experience in complex computer-controlled, electro-mechanical medical devices is preferred.
• Radiation oncology device experience is preferred but not required.

Other Requirements

• Capable of working onsite at our Orange County (Irvine) location.
• Ability to travel overseas to customer installations. Current passport desired.
• Ability and desire to travel for testing activities up to 90 calendar days per year.

Physical Requirements and Work Environment

• Capable of working in safe proximity to residual radiation (with proper PPE).
• Capable of climbing steps (less than 30) around medical device.

Pay

The compensation range for this role is $105,000 - $135,000 annually.

Benefits

• Generous benefits such as Medical, Dental, Vision, 401(k) with company match.
• Unlimited vacation + sick time, companywide December holiday.
• Wellness program, parental leave.
• A collaborative environment: An organization where talents and interests can plug in to different groups throughout the organization.
• Potential for equity participation.
• HQ in Southern California.
• Employee events on and off-site.
• A commitment to upholding and growing an inclusive organization.