Senior Quality Engineer
Job description
About the role
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. The Senior Quality Engineer will serve as a Design Control subject matter expert, 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. This individual will guide quality engineering activities throughout the product lifecycle, from initial development through sustained product changes and manufacturing implementation. The role will identify process roadblocks and opportunities to improve efficiency while maintaining compliance with evolving regulations. This position reports to the Director, Quality.
Location: USA
Engagement: Full-time, hybrid
What you'll do
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 control activities including design planning, design inputs, design outputs, design reviews, design verification, design validation, and design changes.
Assess product changes for quality impact and ensure execution in accordance with Noctrix procedures, regulatory requirements, and industry best practices.
Support verification and validation activities, oversee risk management processes, and integrate quality considerations across the product development lifecycle.
Lead Quality Engineering activities associated with manufacturing implementation, working closely with Operations, Manufacturing, Engineering, and contract manufacturers.
Identify process roadblocks and drive continuous improvement initiatives to enhance efficiency while maintaining compliance.
Partner with Regulatory Affairs, Clinical Affairs, Engineering, Operations, project leads, suppliers, and external stakeholders to ensure alignment on quality expectations and deliverables.
Perform root cause analysis, investigate nonconformances, and oversee corrective and preventive actions to prevent recurrence and ensure product integrity.
Champion quality metrics, monitor performance indicators, and implement data-driven improvements to strengthen the overall quality management system.
Requirements
This position requires a bachelor's degree in engineering, life sciences, or a related technical field, or equivalent practical experience.
Candidates must possess demonstrated experience in medical device quality engineering, design controls, and regulatory compliance.
The role requires strong knowledge of applicable regulations and standards, including quality management system requirements and guidance documents.
Experience leading design control activities and risk management processes in a medical device environment is essential.
The candidate must have excellent analytical, problem-solving, and communication skills to interface effectively with cross-functional teams.
Strong attention to detail, organizational skills, and the ability to manage multiple priorities in a fast-paced, dynamic environment are required.
The individual must be comfortable working with computer software, document control systems, and quality management tools.
A commitment to following procedures, sustaining compliance, and driving process integrity across the product lifecycle is essential for success in this role.
About the role
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. The Senior Quality Engineer will serve as a Design Control subject matter expert, 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. This individual will guide quality engineering activities throughout the product lifecycle, from initial development through sustained product changes and manufacturing implementation. The role will identify process roadblocks and opportunities to improve efficiency while maintaining compliance with evolving regulations. This position reports to the Director, Quality.
Location: Pleasanton, CA
Engagement: Full-time, hybrid
About the role
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 SOURCE: 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. The Senior Quality Engineer will serve as a Design Control subject matter expert, 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. This individual will guide quality engineering activities throughout the product lifecycle, from initial development through sustained product changes and manufacturing implementation. The role will identify process roadblocks and opportunities to improve efficiency while maintaining compliance with evolving regulations. This position reports to the Director, Quality.
Location: Pleasanton, CA
Engagement: Full-time, hybrid
What you'll do
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 control activities including design planning, design inputs, design outputs, design reviews, design verification, design validation, and design changes.
Assess product changes for quality impact and ensure execution in accordance with Noctrix procedures, regulatory requirements, and industry best practices.
Support verification and validation activities, oversee risk management processes, and integrate quality considerations across the product development lifecycle.
Lead Quality Engineering activities associated with manufacturing implementation, working closely with Operations, Manufacturing, Engineering, and contract manufacturers.
Identify process roadblocks and drive continuous improvement initiatives to enhance efficiency while maintaining compliance.
Partner with Regulatory Affairs, Clinical Affairs, Engineering, Operations, project leads, suppliers, and external stakeholders to ensure alignment on quality expectations and deliverables.
Perform root cause analysis, investigate nonconformances, and oversee corrective and preventive actions to prevent recurrence and ensure product integrity.
Champion quality metrics, monitor performance indicators, and implement data-driven improvements to strengthen the overall quality management system.
Requirements
This position requires a bachelor's degree in engineering, life sciences, or a related technical field, or equivalent practical experience.
Candidates must possess demonstrated experience in medical device quality engineering, design controls, and regulatory compliance.
The role requires strong knowledge of applicable regulations and standards, including quality management system requirements and guidance documents.
Experience leading design control activities and risk management processes in a medical device environment is essential.
The candidate must have excellent analytical, problem-solving, and communication skills to interface effectively with cross-functional teams.
Strong attention to detail, organizational skills, and the ability to manage multiple priorities in a fast-paced, dynamic environment are required.
The individual must be comfortable working with computer software, document control systems, and quality management tools.
A commitment to following procedures, sustaining compliance, and driving process integrity across the product lifecycle is essential for success in this role.