Bachelor's degree and 5 years or Master's degree and 3 years of experience in design assurance, new product development, or related medical device experience. (Degree in an engineering discipline or related field of study.) Self-motivated with a passion for solving problems and a bias for action Hands-on approach to product development Strong communication skills (verbal & written) Demonstrated use of Quality tools/methodologies ISO 13485, ISO 14971, and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis Ability to travel up to 10% Quality integration experience Risk Management and ISO 14971 experience Proven ability to influence without authority Ability to effectively work and collaborate in a mixed onsite + remote environment
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