Job Information
Nonin Medical Inc Design Assurance Engineer in Plymouth, Minnesota
Execute quality and Design Assurance (DA) activities to support all Nonin Medical product lines and business initiatives. Determine and define quality and DA requirements to stakeholders throughout the company with emphasis on business groups strategic objectives. Ensure company products and operations comply with applicable quality and regulatory standard requirements including FDA, EU MDR and ISO 13485 requirements. Perform execution of pre-market strategic quality and DA product development activities and provide guidance and support for related post-market quality activities in collaboration with post-market team counterparts. Direct and enable compliant, efficient and risk-based execution of quality and DA strategy and supporting processes including design control, product verification/qualification, translation of VoC/clinical use environment into design inputs, external standards compliance and control, design for reliability, and design history file process owner. Execute new product development quality strategies including identification of applicable standards, design verification testing and human factors engineering. Serve as risk management owner and utilize knowledge of electrical, software and usability standards. Provide recommendations for how to overcome quality barriers and resolve any conflicts. Conduct gap assessments for remediation plans for Product Technical files, reclassification, GSPR and updating standard operating procedures (SOPs). Position requires domestic travel up to 15% as needed and customary for the occupation.