We are seeking a highly skilled Design Quality Assurance Engineer II to join our team on the new Renal Denervation business. This is an exciting opportunity to be part of a cross-functional team that drives product development through commercialization.
Key Responsibilities
* Support 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
* 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 and/or software 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
* Apply systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
Required Skills and Qualifications:
* Bachelor's Degree in Mechanical, Electrical or Biomedical Engineering, or equivalent (minimum NFQ Level 8 qualification)
* Minimum of 3 years of experience in design assurance, quality, or related medical device or regulated industry experience
* Self-motivated with a passion for solving problems and a bias for action
* ISO 13485/Quality System Regulations, ISO 14971/Risk Management understanding
In this role, you will have access to the latest tools, information, and training to advance your skills and career.