Senior Electrical Quality Engineer

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.

A day in the life:

This dynamic position ensures the highest quality and reliability for all CVRx products across new product development, manufacturing, and supplier operations. You will play a crucial role in risk management, design validation, and supplier and process qualification. You'll oversee the disposition of nonconforming materials and devices, and tackle field issues, CAPAs, complaints, and clinical adverse events. Join us to make a significant impact on product excellence and patient safety!

• Lead the charge in ensuring top-notch quality and reliability for new hardware, firmware, and software development projects.

• Take the helm in managing and documenting risk management activities, including reliability analysis, risk and hazard assessment, FMEA, and hazard analysis.

• Ensure seamless compliance with quality systems, risk management, and medical device standards, encompassing cybersecurity and usability, while maintaining crucial regulatory documentation.

• Review and green-light design and development documents, protocols, and reports for hardware, software, and firmware.

• Oversee design validation testing and reporting, generating essential protocols and reports.

• Craft or review Test Plans and Reports for production and qualification tests.

• Manage Nonconforming Material Reports, Deviations, and Product holds to bolster manufacturing operations.

• Document process FMEA and offer insights for process evaluations, qualifications, and validations.

• Spearhead supplier and component selection and qualification, along with equipment selection and qualification.

• Execute statistical analysis and provide sample size inputs for qualification/validation testing.

• Tackle CAPA issues, investigate returned products and complaints, and perform root cause analysis and health hazard assessments.

• Produce and review non-product software documentation related to field support, manufacturing, and development applications.

• Assist with internal audits to ensure regulatory compliance.

• Drive continuous improvement strategies for quality functions.

• Conduct Gage R&R studies and meticulously document results.

• Embrace miscellaneous duties as assigned to uphold excellence in quality and reliability.