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Technician Manufacturing, TMTT NPD

Company: Edwards Lifesciences
Location: Irvine
Posted on: May 3, 2021

Job Description:

This is an exciting opportunity within the Transcatheter Mitral and Tricuspid Therapy devices (TMTT) NPD team, currently involved in the manufacturing of transcatheter heart valve technologies. On this innovative team, you will be responsible for providing support to the production and the Manufacturing engineering group. Technician will provide technical manufacturing support to engineering operations.Essential job functions:Execute experiments and tests (following protocols) to develop findings for the validation and improvement of equipment and manufacturing processes/methods based on engineering principles; analyze results, make recommendations, and develop reports for Engineering review. Operate a variety of test equipment to assess characteristics of the manufacturing environment.Compile documentation for archives to ensure appropriate documentation for development work, including ECRs, SOPs, drawings, and tooling, for Engineering approval.Consult with Engineers, Technicians, and Assemblers on processes to execute experiments and/or production runs. Support related to equipment investigations, testing, objective evidence of product dispositions and rework support work necessary.Utilize manufacturing software (e.g., JDE, QMS, PLM) to update documentation in systems.Collaborate with Engineering in the development of training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes.Provide feedback to Engineering on potential opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes.Perform other duties and responsibilities as assigned.Qualifications:High school diploma or equivalent with 5 years of manufacturing experience, such as GMP, clean room, medical device, and experience with automated equipment.Preferred Qualifications:Excellent computer skills required, including experience with MS Office Suite; ERP/MRP systems experience preferred.Ability to read, comprehend, write and speak English, and good communication skills.Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment.Ability to provide feedback in a professional, direct, and tactful manner.Must be able to work in a team environment and with minimum supervision.Proven success adhering to project schedules and managing small projects.Moderate knowledge of validation and improvement of automated equipment.Ability to troubleshoot manufacturing equipment.Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.

Keywords: Edwards Lifesciences, Irvine , Technician Manufacturing, TMTT NPD, Other , Irvine, California

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