Quality Engineer
Intuitive Surgical, S. de R.L de C.V.
Skills, Experience, Education, & Training: English Level: High Demonstrated interest in medical devices, and the medical field Bachelor’s degree in Engineering or Life Sciences Demonstrated understanding of medical device QMS requirements and regulatory requeriments, including but not limited to FDA CFR 21 820 and ISO 13485 Minimum Education: Minimum degree in electrical, mechanical or system engineering, math, or physics. Advanced degree preferred. At least two areas of deep technical expertise applicable to the manufacture of medical robotic systems. A minimum of 5 years’ experience in one of these disciplines and a few years in a second discipline. Example areas of expertise:- Quality science and quality management Quality statistics Medical device software development, software quality best practices Controls, algorithm development Mechanical engineering, with experience relevant to robotic systems Electrical engineering, with experience relevant to robotic systems Design for reliability, manufacturability, serviceability Proven ability to work in teams and to project-manage cross-functionally Strong interpersonal and communication skills Ability to influence others: Passionate about our mission to improve product quality Able to use persuasive, logical arguments based on data Demonstrated understanding of product development lifecycles, design change and document change control, process verification and validation methodologies, production process control methodologies in a medical device environment Previous work experience with product design changes, process verification and validation, as well as production process controls methodologies in an FDA/ISO regulated environment Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.
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