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R D Staff Mechanical Engineer

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Irvine, CA

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The Cardiovascular & Specialty Solutions (CSS) Group,part of the Medical Devices sector within Johnson & Johnson, is recruitingnfor a R&D Staff Engineer for Acclarent, Inc locatednin Irvine, CA. The CSS Group consists of six diverse businesses includingnAcclarent, Advanced Sterilization Products (ASP), Biosense Webster (BWI),nCodman Neuro, Mentor, and Sterilmed. The CSS Group serves a diverse base ofncustomers in Ear, Nose and Throat (ENT), Infection Prevention,nElectrophysiology (EP), Neurovascular and Neurosurgery, Surgical andnNon-Surgical Aesthetics, and Reprocessing. Acclarent, Inc. is a medical device company, whose focus is to free patients tonlive better lives by designing, developing, and commercializing medical devicesnthat address conditions affecting the ear, nose, and throat. Learn more aboutnAcclarent at ****Acclarent, Inc. is seeking a R&D Staff Engineer whonis hands-on and will execute specific & general assignments/projects thatnprovide innovative, functional, cost effective product designs in a team basednenvironment. The ideal candidate has a strong technical leadership backgroundnin a regulated industry. ESSENTIALnDUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned. Intensive and diversified implementation of knowledge of engineering principles and practices in broad areas of assignments and related fieldsIndependent decision making on engineering problems and methods, and representation of the organization in conferences to resolve important questions and to plan and coordinate workLeading development projects core teams as the R&D representative and project lead.Leading the engineering team efforts around defining specifications and requirements and performing risk analysis. Translating user needs to performance and usability requirements.Writing requirement documents and creating drawings for device architecture and design. Acting as Project team leader. Performing measurements, creating engineering designs, developing plans and keeping laboratory notebooks on all work.Building simulations and models of device and its clinical environment, and leading feasibility studies.Guiding all types of technical experts (Software, Hardware, Mechanical designers and others) in design activities.Planning and conducting verifications and validations.Planning and conducting integration and Proof of Design tests.Developing tools for design verification and production testing.Performing failure analysis and investigations.Conducting tests (Bench, V&V, in vivo), developing and utilizing test protocols and generating written reports.Ability and discipline to adhere to schedules and tasks based on instructions/guidance from company leadership.Ability to maintain & operate lab equipment, after short training, such as Oscilloscopes, Multimeters, digital microscopes, 3D printers, and CNC machine.Develop Test Methods and conduct hands-on bench testing on Products to analyze Performance.Multi-task on multiple projects or multiple activities on one project.Act as liaison between external vendors and the product development core teamMentor Junior engineers to develop technical skills as well as influence skillsTravel to customer sites, domestic and international, to gather VOC, perform testing and/or perform troubleshooting activitiesBe responsible for communicating business related issues or opportunities to next management levelBe responsible for ensuring subordinates (if assigned) follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good conditionBe responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.Perform other duties assigned as needednQualificationsA minimum of a Bacheloru2019s degree in a relevant discipline with 6 years of related engineering experience; or MS in relevant discipline with 4 years of related engineering experience; or Ph.D. in relevant discipline with 2 years of related engineering experience is required. Has significant complex level engineering experience is requiredExperience leading cross functional project teams is preferred.Experience in the medical device or aerospace industry would be an assetExperience in medical device design, development, testing or manufacturing is highly preferred.Working knowledge in using test lab equipment and integration for testing purposes using them is preferred. Knowledge of software programming and/or scripting languages is preferred.Demonstrated proficiency in solid modeling or similar CAD design is preferred.May be required to work in a clean-room environment. This position is located in Irvine CA and may require up to 25% travel internationally/domestically. Johnson &nJohnson Family of Companies are equal opportunity employers, and all qualifiednapplicants will receive consideration for employment without regard to race,ncolor, religion, sex, sexual orientation, gender identity, genetic information,nnational origin, protected veteran status, disability status, or any otherncharacteristic protected by law.

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