Quality Systems Engineer

About Nudge At Nudge, our mission is to develop the best technology for interfacing with the brain to improve people's lives. We're starting with an approach that we believe can help the most people the fastest, and also allow us to learn as much about the brain as possible: developing a non-invasive, ultrasound-based device that can stimulate and image the brain at high resolution and depth. This is a vertically integrated effort building cutting-edge hardware, software, and research capabilities to create products that can benefit millions — and eventually billions — of people.

To succeed, we need to assemble world-class teams across everything we do. We hire people who are exceptional at their craft, believe hard things are worth doing, and execute relentlessly — people who expect the highest levels of both rigor and integrity from each other.

About The Role As a quality systems engineer at Nudge, you will:

• Ensure that new and existing product designs and processes meet all internal and regulatory requirements with respect to safety and performance
• Partner in new product development by leading quality critical discussions, influencing key decisions, and driving necessary process changes across design controls, investigational studies, and clinical trials
• Effectively manage multiple tasks and drive execution of change orders
• Initiate and/or support corrective action and preventive action (CAPAs) and non-conformances, leading investigations and implementing mitigations
• Represent and cultivate a culture of quality by working with interdisciplinary teams to set expectations, identify gaps, and meet a high internal bar for rigor

About You We are looking for quality systems engineers with at least 2 years of industry experience. Regardless of career level, you should have:

• Experience with design controls, product/process validation, and risk management
• A degree in an engineering or scientific discipline (e.g., biomedical engineering, electrical engineering, neuroscience) or equivalent hands-on experience
• Familiarity with Good Clinical Practice (GCP) and human factors
• Familiarity with the FDA QMSR, ISO 13485, and ISO 14971
• Experience conducting risk management activities using tools such as failure mode and effects analysis (FMEA)
• Strong technical writing skills
• High integrity and strong professional judgement