Senior Principal​/Principal Supply Chain and Test Engineer; MedTech; Hybrid in Minneapolis

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 Hybrid in Brooklyn Park, MN with a required 3-4 days onsite. You must reside in the Greater Minneapolis - Saint Paul, MN area to be considered for this hybrid role. CVRx is unable to provide sponsorship (new or transfer) for this work opportunity at this time.

As a key member of the operations and development team, this position will provide supply chain and test engineering expertise for all CVRx products for new product development and operations. Key inputs will be to supplier and purchased product selection and qualification, management of supply chain issues (primarily electrical components), and the development and maintenance of design verification and production testing systems.

This position recommends and implements strategic direction for hardware and software test platforms and methodologies.

• Identify the strategic direction for automated test platforms to ensure re-usability, scalability, favorable cost, and favorable test times.
• Define and manage projects related to the development of automated test platforms.
• Develop and maintain test platforms (both hardware and software) intended for design verification and production test. This includes maximizing availability, improving test coverage (as needed), and reducing test time. Test system software uses LabVIEW, SQL, and other programming languages as required.
• Develop test specifications, schematics, protocols, and reports for design verification and production test.
• Plan, perform, coordinate, and/or oversee design verification testing and reporting.
• Analyze test results to proactively identify issues and optimize yield for design verification and production test.
• Implement root cause analysis, corrective and preventive actions to resolve product and test issues, including purchased parts.
• Coordinate and/or perform failure analysis and troubleshooting of prototypes, products, and equipment.
• Provide statistical analysis and sample size inputs to production and development of qualification/validation testing and data.
• Plan, perform, or assist with Gage R&R studies of equipment.

• Provide engineering support of production as assigned.
• Develop and maintain non-product software and firmware; this includes SW/FW items related to field support, manufacturing, and development.
  
  SW/FW items use C, C#, Visual Basic, and other programming languages as required.
• Participate in or lead implementation and support of manufacturing planning/execution software systems. This include the implementation of electronic travelers, inventory management, purchased product ordering, etc.
• Participate in the disposition of nonconforming materials, products, product holds, and deviations.
• Participate in risk management activities such as reliability analysis, risk and hazard assessment, failure mode effects analysis, hazard analysis, and fault tree analysis.
• Provide input and approval of design and development documentation.
• Provide ownership or oversight to specific corrective and preventive action issues, as assigned.
• Assist in the investigation of returned products, field issues, complaints, and clinical adverse events with respect to root cause analysis, potential health risks, and corrective and preventive action activities.
• Participate in internal audits for compliance to regulations and CVRx SOPs.
• Develop and implement strategies for the continuous improvement of the functions for which the position is responsible.

• BS Degree in electrical engineering, computer science or software engineering or technical equivalent plus 15 years or more experience in a medical device company
• Experience as an engineer in verification activities, verification systems, and production test systems in the medical device environment
• Development and Test experience in SW and FW using C, C#, Visual Basic, and other programming languages
• Test system software experience using LabVIEW, SQL, and…