| Medical Devices Validation : OH at Cincinnati, Ohio, USA |
| Email: [email protected] |
| From: Chandra s, Siri Info [email protected] Reply to: [email protected] Role name:EngineerRole Description: Component Development, Tool Design, Design verification and Validation, Process Qualification, Engineering BuildCompetencies:EIS : Medical Device & RegulationsExperience (Years):4-6Essential Skills:Component Development EngineerComponent Development Engineer Experience in development of medical device components, building device assemblies and instruments. Change control in a regulated environment (preferably medical device) Experience in Plastic/Metal Injection molding Experience in resolving injection molding problems. Manufacturing and process development experience Experience with assembly techniques and equipment technologies Six Sigma Green Belt Process validation (GMP) Statistical process control / capability analysis Measurement system analysis, including GR&R Risk analysis, including use of FMEA Engineering drawing interpretation including GD&T fundamentals Know- how about Product Life Cycle Management Must have experience in the medical devices industry as well as a basic understanding of the regulatory requirements Must have experience in Engineering Documentation for medical devices (Product Design & Development Documents, Protocols, Test Reports, MEMOs and Rationales for Engineering Activities) Experience on equipment/ tool development and qualification Good knowledge in design program/project approach and governance Experience in Design verification and Validation Knowledge of statistical analysis and its applicability to derive engineering rationale Knowledge of change management plans Preferred experience with design, engineering and functioning of surgical devices Development & Conduct of Engineering /Test Studies Experience in Process Qualification (IQ/OQ/PQ) and Factory Acceptance Testing Knowledge of Design of Experiments or Process Characterization Experience in different manufacturing and assembly process, DFMA principles Experience in custom fixture/gauge design/Fail proof principles Exposure to trouble shooting and root cause analysis Preferred experience in process improvement strategies to improve efficiency and throughput Exposure in automation involving pneumatics/hydraulics/PLCs Exposure to Optical Vision based measurement systems Exposure to Software requirements Development for assembly equipment Knowledge of Ergonomics and Safety requirements in equipment designDesirable Skills: Project management activities, including planning, developing and tracking schedules, and communication Responsibilities include resolving plastic/metal Injection molding problems. Collaborating with cross-functional teams to gain alignment on project plans and testing strategies. Coordinating with other projects to determine the product configuration strategy (which version of each product will be tested) Authoring and leading the activities (i.e. component development, Engineering built and verification, validation etc.) through the Ethicon change control system Driving the activities of each line transfer, including tactical planning and logistics to navigate obstacles Coordinating with other team members executing the transfer Root cause analysis and troubleshooting for issues post transfer Critically reviewing test protocols and reports Travel to different Manufacturing plants Leading or supporting other LCE projects, as needed Make decisions on the basis of result and outcome in alignment with customer needs Meet delivery promise in terms of budget and timescales Track Project progress and make necessary changes to project execution as needed to ensure achievement of project goals Work within a multi-discipline team, consisting of the R&D and Lifecycle Design and Development engineers, Project Managers, document control specialists Liaison with customer designated point of contact and functional area point of contact Multiple Project Planning and executionCountry:United StatesBranch | City | Location:TCS - Cincinnati, OH Blue Ash Blue Ash, OH Keywords: rlang Ohio Medical Devices Validation : OH [email protected] |
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| Fri Sep 13 17:24:00 UTC 2024 |