Why work for CVRx? CVRx pioneers' unique therapies that harness and harmonize the body's natural systems, benefiting society and making CVRx a universal role model in healthcare. We value our commitments to others and continue to overcome challenges through determination, collaboration and purpose. If our culture and values speak to you, and if you have a passion for cutting-edge medical technologies, join our team and our mission to help others live better lives. This is a full-time role and our selected candidate will be expected to work onsite, Monday through Friday, at our Brooklyn Park, MN Headquarters. A day in the life: As a Manufacturing Quality Engineer at CVRx, you'll take on a hands-on, impactful role supporting day-to-day production and quality efforts. This role is embedded in our manufacturing environment-working directly with operators, equipment, and cross-functional teams to ensure our life-changing technology is built to the highest standards. You'll apply technical expertise, problem-solving skills, and attention to detail to continuously improve our processes and systems. Key Duties and Responsibilities: * Provide quality and reliability support for manufactured products, including new product development projects. * Contribute to the identification and rollout of process improvements aimed at enhancing product quality and reliability. * Lead or participate in the investigation and resolution of Non-Conformances (NMRs) and corrective/preventative actions (CAPAs) related to manufacturing, design and suppliers, including returned product and field complaints * Lead or support process and equipment evaluations, characterizations, qualifications, and validations. * Learn and assist with risk management activities such as reliability analysis, risk and hazard assessment, failure mode effects analysis (FMEA), and hazard analysis. * Act as a technical resource on the production floor-investigating real-time issues, conducting root-cause analysis, and helping implement quality-focused solutions. * Assist in supplier and component qualification activities, including hands-on inspection and evaluation of components, sub-assemblies, and manufacturing processes. * Review and improve incoming inspection and in-process measurements for accuracy or time, as assigned. * Plan, perform, and/or oversee design validation testing and reporting for new products, designs, or process changes. * Support product labeling updates and artwork modifications by helping streamline and validate labeling processes. * Assist in coordinating facility layout changes, tooling qualifications, and capital equipment installations. * Learn and assist in performing internal and supplier audits for compliance to regulations and CVRx standard operating procedures (SOPs). * Support external audits (FDA, EU, MDSAP, etc.) for compliance to regulations. * Learn and gain understanding of regulations and standards in the areas of quality systems, risk management, medical device development, and usability, with responsibilities for assisting with generation and maintenance of regulatory requirements documentation.