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Cook Medical, Inc. Design Assurance Engineer - 2021-8340 in Bloomington, Indiana

Design Assurance EngineerPosting Date 17 hours ago (1/9/2021 1:59 AM)Requisition ID 2021-8340 Job Location(s) Bloomington IN United States Travel Less than 10% Position Type Full Time Company Cook Medical Holdings Category EngineeringOverviewThe Design Assurance Engineer at Cook Medical provides input, support and guidance to new product / process development (NPD) teams and ensures that documentation is compliant with established Cook Medical quality system requirements.ResponsibilitiesCoach and advise NPD teams on the application of Cook Medical global Design Controls, Process Development and Risk Management policies, procedures, and systemsServe as a direct team member on assigned new product development projects, providing input into the projectReview project-related deliverables for compliance with Cook Medical policies and proceduresContribute towards and participate in design reviewsSupport development and deployment of Cook Medical global Design Controls, Process Development and Risk Management policies and proceduresParticipate as global trainer/subject matter expert in specific procedures and systems, as requestedDevelop and maintain a broad understanding of Cook Medical Design Controls, Process Development and Risk Management policies, procedures, and systemsMaintain thorough knowledge of applicable regulations, standards, and guidance documentsUnderstand and be accountable for conducting Cook business with integrity and in compliance with applicable standards, including Cook policiesWithin scope of responsibility, ensure all quality, regulatory, compliance, and product-specific requirements are metQualificationsBachelor's degree in Engineering, preferably in Mechanical, Chemical, Manufacturing or Biomedical disciplinesMinimum 3 years experience in RandD and/or new product development, process development or quality assurance / quality engineeringExperience across broad range of Design Controls, Process Development and Risk Management procedures and systemsEffective oral and written communication skillsExcellent problem solving skills and ability to work in collaborative and independent work situations and environments with minimal supervisionPhysical Requirements:Approximately 95% of the time is spent in a normal office environment requiring sitting and moving around the building. Approximately 5% of time is spent in domestic/international travel to various locations to support project activitiesCollaborate with peers and Managers regularly through on-line communication methods at times during and outside of normal working hours being flexible in accommodating these demandsMust be able to perform the essential functions of the job, with or without reasonable accommodationsOptionsApply for this job online ApplyShareShare the job posting with a friend ReferSorry the Share function is not working properly at this moment. Please refresh the page and try again later.Share on your newsfeed"We are proud to be an equal employment opportunity employer for minorities, women, protected veterans, disabled individuals, and any other protected class."Cook will consider for employment qualified applicants with criminal histories in a manner consistent with applicable federal, state/province and local law.Equal Opportunity Employerminorities/females/veterans/individuals with disabilities/sexual orientation/gender identity