Design Quality Engineer

Job Title: Design Quality EngineerLocation: TexasDuration: 2+ YearsStart Date: ASAPJob SummaryWe are seeking an experienced Design Quality Engineer to lead and support risk management activities across new product development, sustaining engineering, and continuous improvement initiatives. This role plays a critical part in ensuring compliance with global medical device regulations while driving robust risk management processes throughout the product lifecycle—from concept through commercialization and end-of-life.The ideal candidate will bring a strong design and manufacturing background, deep expertise in risk management standards, and the ability to collaborate effectively with cross-functional and external partners in a regulated environment.Key ResponsibilitiesLead and provide expert guidance on Risk Management and Human Factors Engineering activities throughout all phases of product development and lifecycle management.Plan, organize, execute, and report risk management activities in collaboration with cross-functional project teams.Develop, implement, and continuously improve risk management processes, procedures, tools, and technologies.Establish and manage key performance indicators (KPIs) and metrics to evaluate the effectiveness of risk management practices.Conduct SWAT assessments to identify gaps and drive continuous improvement across risk management and related business processes.Support and lead New Product Development (NPD), Sustaining Engineering, and Continuous Improvementprojects of varying complexity.Partner with internal stakeholders and external design/development vendors to ensure timely delivery of Design and Reliability Assurance deliverables.Provide technical support related to planning, execution, documentation, reporting, and communication of design assurance activities.Work independently while managing priorities and resources to meet organizational goals and project timelines.Required Qualifications & ExperienceBachelor’s degree in Engineering (Mechanical, Electrical, Chemical, or Systems) or Science (Biology or Chemistry).Minimum 8 years of experience in a Quality Assurance or Design Quality role within the medical device or other regulated industry.Strong working knowledge of:ISO 14971 (2019) – Risk ManagementISO 13485 – Quality Management SystemsIEC 62366 – Usability EngineeringFDA QSR and cGMPMedical Device Directive (MDD)Experience with Design for Six Sigma (DFSS) methodologies.Solid background in design and manufacturing processes.Demonstrated expertise in risk management tools, processes, and best practices.Strong analytical and problem-solving skills with proficiency in statistical sampling and data analysis methods.Excellent written, verbal, and organizational communication skills.Proficient in MS Office Suite and statistical software tools.Ability to work independently with minimal supervision and manage multiple priorities effectively.Preferred / Nice-to-Have SkillsFamiliarity with EU MDR requirements.Conversational Spanish language skills.Experience supporting global, cross-functional development teams.Navya MarripudiLead Recruiter | S4 Analyticsnavya@s4analytix.com+1 (551) 300-0477 Ext.108