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o Hands on experience in design and developmento Hands on experience in FDA regulated Design Control, Change Control, NPD flow.o Good understanding of ISO 13485, 21 CFR Part 820 standards and risk management (ISO 14971)o Design-related experience and knowledge of general design engineering and DFMA principles, component manufacturing processes, tooling methodologies, material properties, and regulatory complianceo Experience in NPD of Plastic/Metal componentso Basic engineering (e.g., statistical techniques, validation protocol, process capability studies, process validation, developing solutions that meet quality, performance, and cost commitments).o Experience with CAD/CAM and design analysis software with a basic knowledge and understanding of medical regulatory requirementso Risk Management activities Proven ability to perform root cause investigations, and CAPA processo Writing technical documents is requiredo Expected to lead the engineering change projects with minimal support from client SMEso Organizes and conducts Engineering buildsLead Change management activitieso Ability to understand and manage medical device manufacturing requirements for product or process change managemento Organize, plan, and execute change management plans for key Cost Saving initiativesProject management Skills Experience in project management. Develop and ensure the execution of program organizational, work structure, top-level programand execution plans Work on unusually complex problems and provide highly innovative solutions Establish program management processes and tools and best practices to supportproduct development and drive consistency among projectsThanks and Regards,Mukesh PandeyP: 732-385-3423: E: mukesh.p@e-solutionsinc.comDisclaimer:E-Solutions provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. We especially invite women, minorities, veterans, and individuals with disabilities to apply. EEO/AA/M/F/Vet/Disability.
Vacancy expired!