Principal Design Quality Engineer

Design Control:Oversee design control activities throughout the product lifecycle, ensuring adherence to regulatory standards (e.g., FDA QSR, ISO 13485).Ensure completeness and compliance of Design History Files (DHF) and Device Master Records (DMR)Risk Management:Facilitate risk management activities including hazard analysis, risk assessments (e.g., FMEA), and risk mitigation strategies.Implement and maintain Risk Management Files (RMF) according to ISO 14971 requirements.Verification and Validation:Develop and implement V &V strategies including electrical safety, biocompatibility, usability, and sterilization testing aligned with global regulatory requirements and industry standards.Support verification and validation activities, including protocol development, testing, and report generation.Ensure all testing activities meet regulatory and internal requirements, and results are statistically valid and adequately documented.Test Method Development:Assist with development and optimization of test methods, considering factors such as device complexity, materials, and intended use.Design experiments and protocols to validate test methods, ensuring accuracy, repeatability, and reproducibility.Plan and execute validation studies to demonstrate the suitability of test methods for their intended purpose.Perform statistical analysis and interpretation of validation data to support method qualification.Quality Assurance:Collaborate with cross-functional teams to establish quality objectives and metrics for design projects.Conduct internal audits and assessments to verify compliance with company procedures and regulatory standards.Regulatory Compliance:Stay current with applicable medical device regulations and standards, and ensure product designs meet regulatory requirements.Support regulatory submissions and responses to regulatory agencies as needed.Continuous Improvement:Drive continuous improvement initiatives related to design assurance processes, identifying opportunities for efficiency and effectiveness enhancements.Implement best practices and lessons learned from previous projects to optimize future design assurance activities.EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.To find out more about Real, please visit