Design Quality Engineer III - WATCHMAN

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, with guidance/collaboration of the team Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. Minimum of a Bachelors Degree in Mechanical, Electrical or Biomedical Engineering, or equivalent. Minimum of 3 years of experience in design assurance, quality, or related medical device or regulated industry experience Some experience in new product development: e.g. creating risk management deliverables (risk management plan/report, hazard analysis, task analysis, dfmea, etc.), design verification ISO 13485, ISO 14971, CFRs, and Quality System Regulations understanding & demonstrated use Excellent organizational and planning skills; drives for results Strong communication skills (verbal & written) and presentation skills Ability to travel up to 10% Experience in developing test methods Experience supporting clinical trials Self-motivated with a passion for solving problems and a bias for action. Focus on detailed work with emphasis on accuracy and completeness Ability to collaborate and work on a global team with peers in R&D, Process Development, Manufacturing and other groups. Experience with Class III Medical Devices