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Staff Component Engineer - Irvine Implant Manufacturing

Company: Edwards Lifesciences Corp
Location: irvine
Posted on: May 3, 2021

Job Description:

This is an exciting opportunity within our Irvine Implant Manufacturing Plant supporting manufacturing engineering for components used to build Surgical, Transcatheter Hearth Valve (THV) and Transcatheter Mitral & Tricuspid Therapies (TMTT) heart valves. The Staff Engineer will be a key member of a cross-functional core team accountable for all aspects of the Components operations value stream (safety, quality, delivery, cost) with support of tasks for sustaining and continuous improvement. This engineer will be the Technical Engineering Lead within the Components operations value stream. In this role, the engineer will manage engineering activities from new product introduction, continuous improvement, global process transfers, line sustaining, validation activities and MES support. Additionally, this engineer will provide mentorship and technical expertise to less experienced engineers on the team and help manage the Components MES phase 2 roll out.Essential job functions: Lead in the identification and ensure implementation of opportunities to optimize/improve manufacturing processes including using engineering methods (e.g., SIX Sigma and LEAN methods) employing technical design skills to re-design/design of and ensure equipment, tools, fixtures, etc. are up to standards. Drive the development and manage the execution of complex experiments and tests (including writing and executing protocols) on a simple product line to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports. Oversee manufacturing support tasks; give instruction to engineers/ technicians on conducting tests; train engineers/ technicians and provide feedback; and coordinate engineer/ technician work. Experienced in executing Validation Activities on equipment (IQ/OQ/PQ) Lead and establish complex project plans to ensure deliverables are completed to customer's expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.). Analyze and resolve complex Manufacturing, Equipment and Compliance issues (e.g., CAPA, non-conformances, audit observations) - Will go to the manufacturing floor and understand the process Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes. Mentor less experienced engineers on the team about statistics, validations, equipment, and engineering fundamentals Collaborates with R, NPD, Quality, Manufacturing, Operations, and personnel at other Edwards Manufacturing facilities and plants to support Components Operations projects and activities Perform other duties and responsibilities as assigned. Required Qualifications: Bachelor's Degree in Engineering or Scientific field with minimum of 6 years of engineering manufacturing experience. Preferred Qualifications: Advanced degree. Medical device industry is preferred. Six Sigma Black Belt Certified is preferred. Experience with engineering methods (e.g., Six Sigma, LEAN methods, process flow charts, value stream mapping, statistics, and validation) for problem solving, continuous process improvement and sustaining manufacturing support.Strong understanding of basic statistics (mean, average, range, standard deviation, normality, confidence intervals, histograms).Strong understanding of statistical and Six Sigma Techniques (Control Charting, DOE, Hypothesis Testing, Gage R, Z-Score, Tolerance Analysis, COV, Regression).Demonstrated use of process and design excellence methodologies to optimize processes and Operations Efficiency.Demonstrated use of Design for Manufacturability, Industrial Engineering and lean experience leading to manufacturing efficiency improvement.Experience using Solid Works/CAD softwareExperience with Design for ManufacturingGood computer skills in usage of MS Office Suite including MS Project.Good documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills.Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering.Solid problem-solving, organizational, analytical and critical thinking skills.Solid understanding of processes and equipment used in assigned work.Knowledge of applicable FDA regulations for medical device industry.Ability to interact professionally with all organizational levels.Must be able to work in a team environment, including the ability to manage vendors and project stakeholders.Ability to build productive internal/external working relationships.E dwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

Keywords: Edwards Lifesciences Corp, Irvine , Staff Component Engineer - Irvine Implant Manufacturing, Other , irvine, California

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