Principal Design Quality Engineer

Support the verification, validation, and usability planning and testing to meet or exceed internal and external requirements Develop, update, and maintain Design History File and work with R&D for Design Input / Output documentation (Product Specification, Component Specifications, and Prints) Work within a cross-functional team to identify and implement effective controls and support product development through commercialization. Support regulatory submissions to notified bodies. Develop, update, and maintain product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs) Develop, update, and maintain the usability file: plan, participate in usability assessments, and generate/update usability documentation Actively participate in the Design Change process for systems to ensure the proposed changes to the products are systemically and thoroughly analyzed and assessed through the Design Control process. Apply systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues, while also mentoring others to enhance their skills and expertise. Minimum of a Bachelors Degree in Mechanical, Electrical or Biomedical Engineering, or equivalent. Minimum of 5 years of experience in design assurance, quality, or related medical device or regulated industry experience with an ability to develop clinical understanding Demonstrated independent ownership and completion of project deliverables for multiple design projects. Self-motivated with a passion for solving problems and a bias for action. ISO 13485, ISO 14971, and Quality System Regulations understanding Excellent communication skills (verbal & written) and presentation skills Focus on detailed work with emphasis on accuracy and completeness High energy problem solver capable of driving items to closure Excellent organizational and planning skills; drives for results Ability to collaborate and work on a global team with peers in R&D, Process Development, Manufacturing and other groups.