Senior Design Assurance (Quality) Engineer
CurrentParticipate as a product development team member and with technical competencies in electrical hardware, firmware and software to educate, direct, manage team activities and generate the following deliverables:• Quality Planning• Risk management• Reliability and failure analysis• Root cause analysis, problem solving, continuous improvement and related corrective and preventive action as they relate to complaints, non-conforming material, post-market surveillance (PMS), and other quality data • Input and approval for component qualifications, design verification and validation testing of new designs and design changes (including product software/firmware verification) to ensure product design quality and integrity• Develop test software in collaboration with R&D and Manufacturing Engineering, as applicable• Generate protocols, execute testing and generate reports for validation of products• Establishing Acceptance Criteria for verification and validation activities• Evaluating design changes• CAPA/NCMR investigations• Defining and ensuring compliance with applicable technical standards• Input and approval for validation of automated processes and software used in the quality system.• Input to, and development of, specifications, standards, test protocols, test reports, procedures and other documentation and records related design and development• Review specifications as the quality team member to ensure appropriate quality system compliance