**Senior Design Assurance Engineer**
Main Responsibilities
* Ensure design assurance and quality control through comprehensive testing and validation, ensuring test methods are robust and compliant with regulatory standards.
* Lead or support corrective and preventive actions (CAPA) initiatives related to design and test methods, driving continuous improvement.
* Participate in design controls process, including design reviews and design change processes, ensuring compliance with industry standards and regulatory requirements.
* Conduct and manage design failure mode and effects analysis (dFMEA) and ensure seamless transition to process FMEA (pFMEA) during the design-to-manufacturing phase.
* Compile technical documentation for regulatory submissions, ensuring compliance with industry standards and regulatory requirements.
* Support human factors engineering and usability studies to optimize product safety and user experience.
Key Skills and Experience
* Minimum of 3+ years of experience in Design Assurance or R&D within the medical device industry.
* Hands-on experience working within an ISO 13485 Quality Management System (QMS) or equivalent regulated environment.
* Strong experience with design controls, design reviews, and design change processes.
* Proficient in conducting Failure Mode and Effects Analysis (FMEA), particularly design FMEA.
* Demonstrated experience in problem-solving and root cause investigations.
Educational Background and Technical Skills
* Bachelor's degree in Engineering, Scientific, or Technical field (ASQ Certified Quality Engineer (CQE) accepted).
* Proficiency in statistical tools and methods for design and quality data analysis.
* Strong working knowledge of MS Excel and MS Word for technical reporting and documentation.
* Familiarity with Quality Management Systems (QMS) and regulatory requirements, including ISO 13485.