Quality Systems Engineer

About the Company

At Nudge, our mission is to develop the best technology for interfacing with the brain to improve people's lives. We are developing a non-invasive, ultrasound-based device that can stimulate and image the brain at high resolution and depth.

Responsibilities

• 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 and driving process changes across design controls, investigational studies, and clinical trials
• Effectively manage multiple tasks and drive execution of change orders
• Initiate and 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 and identify gaps

Requirements

• At least 2 years of industry experience
• Experience with design controls, product/process validation, and risk management
• 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 FDA QMSR, ISO 13485, and ISO 14971
• Experience conducting risk management activities using tools such as FMEA
• Strong technical writing skills
• High integrity and strong professional judgement