Failure Analysis Engineer at Auris Health, Inc. Redwood City, CA Company Description: Auris is a technology company defining the future of medical intervention. By combining advancements in medical robotics, instrumentation, navigation and data science, Auris is building a platform technology capable of expanding the applicability of robotics to a spectrum of medical procedures. Overview: As Failure Analysis Engineer, this individual will be responsible for oversight of the complaint handling process. He or she will lead the company complaint handling system, perform investigations into product failures and support post market surveillance activities to ensure that product meets customer, regulatory and business requirements. This position reports to the Senior Manager QMS. Core Job Responsibilities: Drive complaints analysis process: tracking, investigation, analysis, critical issue escalation, documentation, and trending of complaints Collaborate with Engineers, Scientists, Clinical Specialists, Field Service Engineers and Manufacturing personnel to facilitate the complaint investigation process Evaluate all information from a clinical and technical perspective to ensure appropriate analysis, investigation and root cause is documented Perform complaint investigations including: analyzing complaint records for root causes of failures, assessing risk, updating complaint investigation records, and escalating issues to meet MDR requirements Participate in post market surveillance activities to monitor and develop long-term improvements to our product Develop and manage methods to analyze customer feedback and complaint historical data to identify trends, areas for investigation and escalation Develop, establish, prepare and distribute dashboards and reports to assure complaints are processed in a timely manner Participate and collaborate with team members to identify process improvements to drive efficiency and compliance. Assist in the deployment of an electronic complaint handling system Understand manufacturing and software processes Support reviews and audits as required. Strong interpersonal, planning, and organization skills Must have excellent oral and written communication skills Strong and creative problem-solving skills Must be able to work independently Other related duties as may be assigned Required Knowledge/Skills, Education, And Experience Bachelors degree in a life science discipline (such as chemistry or biology) or Bachelors degree in Computer Science, Mechanical Engineering, Software Engineering or related area of study 3-5 years relevant experience in a regulated environment (medical device or pharmaceutical) Thorough understanding of FDA 21 CFR 820, 803, 806 and ISO 13485 requirements Demonstrated ability to articulate risk and make critical decisions regarding product quality or quality system compliance Proficiency in risk analysis tools and techniques (e.g. Hazard Analysis, FMEA, Fault Tree, Pareto diagrams, cause-and-effect diagrams, 5 whys, etc.) Tenacious attention to detail and consistency Basic statistical methods including trend analysis, pareto, and other basic charting techniques is a plus. Outstanding communication, presentation and interpersonal skills working within all levels of the organization An approachable individual who provides a high level of teamwork and cross-functional collaboration. Flexibility to support changing assignments and priorities in an independent and reliable manner while maintaining a positive and collaborative attitude Advanced analytical and problem-solving skills. Apply for this Job * Required (Optional) Almost there! Review your information then click 'Submit Application' to apply. First Name * Last Name * Email * Phone Location (City) Resume/CV * Drop files here Cover Letter Drop files here When autocomplete results are available use up and down arrows to review Education LinkedIn Profile Website How did you hear about this job? Preferred Name Let us know if you have a preferred nickname. 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