Senior Design Quality Engineer - Axonics Integration

Minimum of a bachelor's degree in mechanical, electrical, or biomedical engineering (or other related technical discipline) 5+ years of experience in design assurance, new product development or related medical device / regulated industry experience Self-motivated with a passion for solving problems and a bias for action Strong communication skills (verbal & written) Demonstrated use of Quality tools/methodologies Ability to effectively work and collaborate in a mixed onsite + remote environment Demonstrated experience creating detailed technical documents Experience working with medical electrical equipment and/or active implantables Quality Integration experience ISO 13485, ISO 14971 and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis Experienced problem solver, capable of facilitating the problem-solving process Adaptable and effective collaborator in a team environment or in self-directed work Experience with design changes, complaint reduction, and corrective action