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Job #03092

About our client Our client is a rapidly growing medical device company headquartered in Texas that is focused on the development and commercialization of various breakthrough minimally invasive technologies. The company has premier investors, an experienced management team and an empowering corporate culture that is focused on the professional development of its employees. This is a strong opportunity for someone that wants to put their drive and initiative to work. Position Location Reliability/Quality Engineer Texas Salary Highly competitive package, commensurate with experience Responsibilities 1) Participate actively 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 including reliability assessment for both new designs and changes to released product 3) Ensure the resolution of all issues raised by the testing 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) Lead cross-functional teams in developing reliability/risk assessments – reliability predictions, hazard analyses, fault tree analyses, FMEAs, etc. 6) Monitor and evaluate field performance, analyze field performance trends, assess risks and recommend corrective action when necessary 7) Lead complaint investigations; document findings and provide reports and analysis 8) Recommend and implement corrective action and appropriate follow up when necessary 9) Ensure documentation and findings are completed in a timely manner and in compliance with FDA and European Regulatory agency standards and procedures 10) Recommend and implement actions or changes to improve quality 11) Review and approve product assurance plans, qualification test plans and test reports 12) Provide statistical input into development of plans and justification of results 13) Ensure resolution of all issues raised during testing 14) Provide technical support for technicians performing 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 ensure 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 in the qualification of new material/ processes to ensure 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) Working knowledge of FDA Good Manufacturing Practices 3) Minimum of 5 years experience in reliability, design assurance or product assurance 4) Experience in structured project management 5) Experience in working with and providing direction to cross-functional teams 6) Experience in the medical device industry 7) Experience in project research and development 8) Experience in process improvement 9) Knowledge of regulatory submission 10) Proficiency in data analysis using statistical techniques, reliability tools and process-improvement techniques 11) Demonstrated problem-solving and critical-thinking abilities 12) Excellent written and oral communication skills