Senior Design Assurance Engineer - Medical Device

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 role is full‑time onsite at our Brooklyn Park, MN headquarters and ourideal candidate is local to the Minneapolis area.

This position provides quality and reliability support for all CVRx products for new product development, manufacturing and supplier operations. Will provide key inputs to the risk management, design validation, supplier and component qualification, and process qualification/validation processes. Responsible for disposition of nonconforming materials and devices. Assists in addressing field issues, Corrective Action Preventive Action (CAPAs), complaints, and clinical adverse events, as appropriate.

• In-depth understanding and practical application of Design Control and Risk Management Concepts.
• Lead risk management activities such as reliability analysis, risk and hazard assessment, failure mode effects analysis (FMEA), and hazard analysis.
• Develop, update and maintain Design History File and Designing Input/Output documentation
• Lead the quality and reliability support for new hardware, firmware, and software product development projects.
• Lead cross functional team to identify and implement effective controls and support product development from concept through commercialization.
• Identify and implement strategies for the continuous improvement of the quality functions for which the position is responsible.
• Assess compliance with regulations and standards in the areas of quality systems, risk management, medical device software development, wireless coexistence, usability, and cybersecurity with responsibilities to generate and maintain regulatory requirements documentation.
• Provide input on or generate, review and approve design and development documentation, protocols and reports for product hardware, software, and firmware.
• Plan, perform, coordinate, and/or oversee design validation testing and reporting for product hardware, software and firmware and generate protocols and reports as required.
• Generate or review and approve Test Plans and associated Test Reports for production and qualification screens and tests.
• Lead and support cross functional root-cause investigation and resolution activities.
• Generate or review and approve Nonconforming Material Reports (NMRs), Deviations, Product holds and Issues to provide quality and reliability support of manufacturing operations.
• Provide input on or generate and review process evaluations, characterizations, qualifications, and validations.
• Plan, perform, coordinate, and oversee supplier and component selection and qualification.
• Perform, review, and approve equipment selection and qualification activities, as required.
• Provide statistical analysis and sample size inputs to production and development qualification/validation testing and data.
• Lead investigation of returned products, field issues, complaints, and clinical adverse events with respect to root cause analysis, potential health risks, and CAPA activities, including health hazard analysis and document the results.
• Plan, perform, or assist with Gage Repeatability and Reproducibility (R&R) studies of equipment and document results.

• BS Degree in Science or Engineering; the technical equivalent of education and experience may be considered
• 5 years or more experience in a medical device company
• Knowledge of FDA QSR and ISO 13485 as well as EU MDR regulatory requirements, guidelines and standards that pertain to medical devices
• Class II or Class III medical device experience - Active implantables experience is preferred
• Proven communication, analytical, organizational, and problem‑solving skills
• Ability to interface with internal and…