Your responsibilities will include: Develops solutions to complex and diverse technical problems which require the regular use of ingenuity and creativity. Builds quality into all aspects of work by maintaining compliance to all quality requirements, defending work of their team, as well as supports internal external regulatory audits Participates as a division representative in cross-divisional projects defining the quality system and may advise management on potential improvements to the quality systems and processes Supports functional and divisional design quality goals and priorities Bachelor's degree in mechanical, electrical, biomedical engineering, or related discipline 5+ years of related experience in design assurance, new product development, or related medical device or regulated industry experience Understanding of electrical safety standards IEC 60601 Experience with reliability testing Demonstrated use of Quality tools/methodologies Strong written/verbal communication skills. Experience with class III medical devices BS in Electrical Engineering Previous R&D experience Strong knowledge of QSR and ISO standards Medical device experience ASQ certification
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