Blind Inc.

Seeking a Sr. Electrical Quality Engineer that ensures the highest quality and reliability for all 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. Position Requirements: BS Degree in Science or Engineering or technical equivalent plus 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. Proven communication, analytical, organizational, and problem solving skills. Ability to interface with internal and external customers in all aspects of the product life cycle. Ability to apply statistics to solve problems and determine sampling plans. Experience with risk and hazard analysis. What we would like to see: Education or experience in electrical engineering or electronics with software experience. Knowledge of additional international regulations, radio equipment regulations, risk management and cybersecurity standards. Active implantables experience. Ability to participate in internal and supplier audits. If interested and qualified, please submit your resume to careers@dr-group.com or visit our website to apply: www.dr-group.com (job #6550) For additional job openings, follow DRG on Social Media! Web: www.dr-group.com LinkedIn: https://www.linkedin.com/company/development-resource-group?trk=companylogo Twitter: https://twitter.com/DRGMN