Quality Engineering Senior

Senior Quality EngineerPleasanton, CANoctrix 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 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 practicesAct as the lead Quality representative for new product development and sustaining product changes involving hardware, firmware, software, labeling, components, suppliers, and related manufacturing updatesGuide project teams through design planning, design inputs, design outputs, design reviews, design verification, design validation, design transfer, design changes, traceability, and risk management activitiesReview proposed product changes and advise teams on the appropriate design control, risk management, verification, validation, and documentation requirementsParticipate in project planning, design reviews, change reviews, and cross-functional technical discussions as the Quality representativeProvide Quality Engineering guidance on verification and validation strategies, protocols, reports, acceptance criteria, traceability, risk assessments, and change implementation plansLead Quality Engineering activities associated with manufacturing updates resulting from new product development and sustaining product changesCoordinate with Engineering, Operations, Manufacturing, contract manufacturers, suppliers, and external partners to ensure product changes are implemented effectively and compliantlySupport supplier, component, and manufacturing changes that may impact product design, safety, performance, regulatory requirements, or manufacturing implementationSupport CAPA and nonconformance activities, including investigation planning, root cause analysis, corrective action development, implementation, and effectiveness evaluationOwn or support risk management activities and documentation for Class II or higher medical devicesReview and approve design control, verification and validation, engineering change, risk management, and manufacturing implementation documentationIdentify process roadblocks, compliance risks, unclear requirements, and inefficiencies affecting NPD, sustaining activities, and product change implementationRecommend and support practical improvements to design control, change management, risk management, verification and validation, and product development processesServe as a Design Control SME during internal audits, external audits, certification audits, regulatory inspections, and Quality System readiness activitiesProvide technical guidance and mentorship to Quality personnel and cross-functional teamsPromote consistent application of Design Control and Quality Engineering best practices across the organizationRequirements:Bachelor's degree or higher in Engineering, Life Sciences, Quality, or a related technical disciplineMinimum of 6 years of Quality Engineering experience within the medical device industrySignificant experience supporting new product development and sustaining product changesStrong working knowledge of FDA Design Control and Quality System requirements, ISO 13485, ISO 14971, risk management, verification and validation, design transfer, and change controlDemonstrated experience serving as a Design Control SME and advising cross-functional teams on regulatory requirements, company procedures, documentation expectations, and best practicesExperience supporting medical device development and product changes involving hardware, firmware, software, labeling, components, suppliers, and manufacturing updatesExperience owning or managing risk management documentation for Class II or higher medical devicesExperience reviewing or approving Design Control, verification and validation, engineering change, and manufacturing implementation documentationExperience supporting Design Transfer and manufacturing implementation activitiesExperience leading or supporting CAPA and nonconformance investigations, root cause analysis, corrective actions, and effectiveness evaluationsStrong understanding of the relationship between product risk, design controls, manufacturing changes, and regulatory complianceStrong analytical and problem-solving skills with the ability to identify compliance risks and recommend practical solutionsExcellent technical writing, documentation, facilitation, and communication skillsStrong organizational skills with the ability to independently manage multiple complex prioritiesDemonstrated ability to influence and guide cross-functional teams without direct authorityPreferred Qualifications:ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or similar professional certificationExperience with therapeutic wearable, connected medical device, or electro-mechanical medical device productsExperience supporting software and firmware development within a medical device Design Control environmentExperience working directly with contract manufacturers and external development partnersExperience supporting FDA inspections, ISO 13485 certification audits, or other regulatory inspectionsExperience with supplier quality and component qualification activitiesExperience mentoring Quality Engineers or serving as a technical leader within a Quality organizationExperience working within a high-growth medical device organizationCompensation:Base Pay: $150,000-$180,000 per yearAnnual Bonus Eligibility Noctrix Health