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Job #03586

About our client Our client is an innovative medical device company with products on the market and a supportive pipeline of new product candidates. They have a great work environment, and are dedicated to the professional development of all their employees. This is an excellent opportunity for the right person. Position Location Reliability/Quality Engineer Texas Salary Highly competitive package, commensurate with experience Responsibilities 1) Participate in product development cycle to ensure reliability and quality issues are addressed and resolved prior to product release 2) Work closely with R&D to develop appropriate qualifications, validations, inspection plans and gauging 3) Assess reliability for new design and changes to released product 4) Lead problem-solving efforts to identify and resolve recurring and new quality or reliability issues to ensure production of safe and effective medical devices 5) Ensure the resolution of all issues raised by the testing 6) Lead cross-functional teams in developing reliability/risk assessments (reliability predictions, hazard analyses, fault tree analyses, FMEAs, etc.) 7) Monitor and evaluate field performance, analyze field performance trends, assess risks and recommend corrective action when necessary 8) Lead complaint investigations, document findings, provide reports and analysis 9) Recommend and implement corrective action and appropriate follow-up when necessary 10) Ensure documentation and findings are completed in a timely manner and compliance with FDA, European Regulatory agency standards and procedures 11) Recommend and implement actions or changes to improve quality 12) Provide statistical input into development of plans and justification of results 13) Review and approve product assurance plans, qualification test plans and test reports 14) Provide technical support for technicians performing testing and assure resolution of all issues raised during testing 15) Define, champion and integrate all testing, including the continuum of DVT, qualification, validation, etc. 16) Use reliability testing to understand design/process margins 17) Review and approve changes to designs/processes and assess impact on product and qualification status and to assure reliability requirements are met 18) Understand integration of component, design and process to ensure adequate design/process margin 19) Provide input for regulatory submissions 20) Support the disposition of discrepant material/processes and qualification of new material/ processes to assure reliability requirements are met 21) Provide design input by reviewing legacy product performance and assessing new technologies 22) Participate in establishing and reviewing specifications/requirements for component, product and processes 23) Provide post-market data to establish project reliability/quality goals and metrics to drive continuous improvement Requirements 1) BS in Engineering or a related field 2) Minimum 5 years experience in reliability, design or product assurance 3) Medical device industry experience 4) Working knowledge of FDA and GMP 5) Experience in structured project management 6) Working experience in providing direction to cross-functional teams 7) Experience in project R&D and process improvement 8) Knowledge of regulatory submission 9) Proficiency in data analysis using statistical techniques, reliability tools and process improvement techniques 10) Excellent communication skills (oral and written) 11) Demonstrated problem-solving and critical thinking abilities