Quality Assurance Engineer

Bachelor’s degree in Mechanical Engineering, Biomedical Engineering or Electrical Engineering.2+ years of experience in design assurance, quality, new product development, or related medical device / regulated industry experienceProblem solver, capable of facilitating the problem-solving processAdaptable and effective collaborator in a team environment and in self-directed workStrong communication skills (verbal & written)Ability to work in a highly matrixed and geographically diverse business environmentDemonstrated use of Quality tools/methodologiesPreferred qualifications:Previous Software or Capital equipment Design Assurance experience is a plusMedical device or other regulated industry experienceStrong knowledge of Quality System Regulation (QSR), Risk Management standards (ISO 14971) and software standards (IEC 62304 or IEC 82304)Experience with 60601, software and cybersecurityExperience working in an Agile environment