Principal Design Quality Engineer

Your responsibilities will include: Develops solutions to complex and diverse technical problems which require the regular use of ingenuity and creativity. Participates as a division representative in cross-divisional projects defining the quality system and may advise management of potential improvements to the quality systems and processes Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues Supports functional and divisional design quality goals and priorities Bachelor's degree in an Engineering discipline 9+ years of experience in design assurance, quality, or related medical device experience; or Master's degree and 7+ years experience. Knowledgeable in Quality System Regulations, Medical Device Regulation, ISO 13485 and ISO 14971 Quality Standards Proven use of Quality tools and methodologies Demonstrated problem-solving, critical thinking, and data analysis capabilities Hands-on approach to product development and qualification Ability to collaborate and influence across multiple, cross-functional teams Strong communication skills (verbal and written) Comfort with self-directed work in addition to collaboration in a team environment Experience with clinical trial support, multi-site teams, and contract manufacturers Self-starter with the ability to identify improvement opportunities Strong ability to successfully multi-task and adapt Comfort speaking to groups of individuals. Presentation skills that comfortably and concisely translate performance and issues to peer and senior management audiences.