The Associate Quality Engineer position is designed to provide the selected candidate with a broad exposure to the design and development process for wearable medical devices that are used by patients around the world on a daily basis. This position will be an integral member of the R&D; team directly supporting the product development phases of Insulet’s innovation pipeline of wearable pump technology. This role will provide exposure to several aspects of Insulet’s design control processes including but not limited to writing and interpreting product requirements, device integration, verification test methods, troubleshooting/design analysis, and design documentation.ResponsibilitiesCollaborate with seasoned Systems Engineers on troubleshooting design issues and methods of improvement.Support all phases of the design and development lifecycle of a medical deviceParticipate in product design or technical reviews.Author and review Engineering Change Orders.Author engineering build requests with direct responsibility for managing engineering materials.Design and set up feasibility tests in a lab environment.Author design feasibility protocols and reports.Participate in product design, technical reviews, and triage brainstorming sessions.Design verification testing execution in support of design improvements, FDA and international clearance,



or commercial release.Contribute to team goals by accomplishing related tasks as requiredEducation and Experience:Minimum RequirementsBS in an Engineering (Biomedical, Electrical, Industrial) discipline (Prefered)Ability to work in a fast paced, dynamic environment with a passion for continuous learningAdvanced EnglishPassionate about improving the lives of othersTechnical writing abilityMicrosoft office suite (Word, Excel, PowerPoint)Effective communication skillsPreferred Skills and Competencies:1-2 yrs experience as a Quality/Project Engineer in the Medical Device or other regulated industry and/or equivalentExperience with lab equipment (testing)Demonstrated working knowledge of engineering principles and scientific methods.General understanding of communication, mobile technology, IoT (Internet of Things); a strong plusExperience with software / product lifecycle tools – Jira, Helix, Bamboo, Bitbucket; a strong plus.Hands-on and inquisitive, not being afraid to challenge a designGeneral understanding of medical devices & regulationsExperience with data analysis (MatLAB)Planning and organization skillsExperience with SolidWorks or Pro-EngineerAbility to organize and judge priorities in a dynamic environment

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📌 Quality Engineer (Ciudad de México)
🏢 Insulet
📍 Ciudad de México