Senior Quality Engineer

Senior Quality Engineer

Pleasanton, CA

Noctrix Health is redefining the treatment of chronic neurological disorders with clinically validated therapeutic wearables. Our team of medical device specialists, neuroscientists, and consumer electronics engineers is dedicated to delivering prescription-grade therapy with an outstanding user experience. We have pioneered the world's first drug-free wearable therapy, clinically proven to alleviate symptoms in adults with drug-resistant Restless Legs Syndrome (RLS). Join us in transforming healthcare, improving lives, and driving meaningful change through innovative medical technology.

We are seeking an experienced Senior Quality Engineer to provide Quality Engineering leadership across new product development (NPD), sustaining product changes, and related manufacturing updates throughout the product lifecycle. This individual will serve as a Design Control subject matter expert (SME), partnering closely with cross-functional teams to ensure product development and change activities are executed in accordance with Noctrix procedures, applicable regulatory requirements, and industry best practices.

The Senior Quality Engineer will work closely with Regulatory Affairs, Clinical Affairs, Engineering, Operations, Manufacturing, project leads, contract manufacturers, suppliers, and external partners to guide design control activities, assess product changes, support verification and validation, integrate risk management, and lead Quality Engineering activities associated with manufacturing implementation. This role will also identify process roadblocks and opportunities to improve efficiency while maintaining compliance.

This position reports to the Director, Quality.

This is a full-time, hybrid position that is located at our Pleasanton headquarters.

Responsibilities:

• Serve as the Design Control subject matter expert and advise product teams on the application of Noctrix SOPs, applicable regulatory requirements, and design control best practices
• Act as the lead Quality representative for new product development and sustaining product changes involving hardware, firmware, software, labeling, components, suppliers, and related manufacturing updates
• Guide project teams through design planning, design inputs, design outputs, design reviews, design verification, design validation, design transfer, design changes, traceability, and risk management activities
• Review proposed product changes and advise teams on the appropriate design control, risk management, verification, validation, and documentation requirements
• Participate in project planning, design reviews, change reviews, and cross-functional technical discussions as the Quality representative
• Provide Quality Engineering guidance on verification and validation strategies, protocols, reports, acceptance criteria, traceability, risk assessments, and change implementation plans
• Lead Quality Engineering activities associated with manufacturing updates resulting from new product development and sustaining product changes
• Coordinate with Engineering, Operations, Manufacturing, contract manufacturers, suppliers, and external partners to ensure product changes are implemented effectively and compliantly
• Support supplier, component, and manufacturing changes that may impact product design, safety, performance, regulatory requirements, or manufacturing implementation
• Support CAPA and nonconformance activities, including investigation planning, root cause analysis, corrective action development, implementation, and effectiveness evaluation
• Own or support risk management activities and documentation for Class II or higher medical devices
• Review and approve design control, verification and validation, engineering change, risk management, and manufacturing implementation documentation
• Identify process roadblocks, compliance risks, unclear requirements, and inefficiencies affecting NPD, sustaining activities, and product change implementation
• Recommend and support practical improvements to design control, change management, risk management, verification and validation, and product development processes
• Serve as a Design Control SME during…