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Principal Reliability Engineer Irvine Implant Manufacturing

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

Job Description:

Joining Edwards Lifesciences means innovating, pushing boundaries, and being creative while always putting patients first. It means solving challenges with colleagues who share your sense of urgency, optimism, and enthusiasm, colleagues who are just as focused on testing their limits and taking ownership. And it means that you will be empowered to get the job done by taking charge of your work and your career. Innovation is at the core of Edwards! Without it, we would not be able to produce the life-saving products and therapies that transform lives around the world. That is why we surround ourselves with people who are not afraid to question the status quo or express a different point of view.Edwards Lifesciences is hiring a Principal Reliability Engineer who will provide expertise in the optimization of manufacturing equipment processes. This is a unique opportunity to be part of our high performing production Irvine Implant Plant. The Principal Reliability Engineer will be managing scalable sustaining and new development manufacturing equipment.KeyResponsibilities:Drive the development and manage the execution of highly complex equipment experiments and tests (including writing and executing protocols) on a platform which includes multiple product lines to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports and collaborate with team members to drive project itiate and lead 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 on new products and/or processes, etc. are up to standards.Train, coach, and guide lower level employees on highly complex procedures.Lead and establish highly complex project plans to ensure deliverables are completed to customers expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.).Analyze and resolve complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations).Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes.May be selected as an Independent Reviewer for design review.May support and lead Business Excellence activities through tier meetings and support business continuity implementation such us Total Productive Maintenance (TPM).Subject matter expert for life cycle reliability on new equipment development and acquisitionPerform other duties and responsibilities as assigned.Qualifications:Bachelor's Degree in Engineering or Scientific field with 8 years of reliability & facilities engineering manufacturing experience.Experience in a regulated manufacturing environment within medical device, biotechnology, pharmaceutical, or related industry.Preferred Qualifications:Advanced degree or Certified Maintenance & Reliability Professional (CMRP). Experience in FDA and cGMP regulations and documentation practices.Proven expertise in usage of MS Office Suite; CAD experience preferred.Recognized as a subject matter expert in reliability equipment operations.Expert understanding of processes and equipment used in assigned work.Proven leadership experience managing different engineering and professional support teams salary, hourly and contractor.Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills.Ability to translate complex and technical information to all levels of the organizations.Advanced problem-solving, organizational, analytical, and critical thinking skills.Strong leadership skills and ability to influence change.Ability to interact professionally with all organizational levels.Ability to manage competing priorities in a fast-paced teracts with senior external representatives on significant technical matters often requiring coordination between organizations.Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.Full timeSDL2017

Keywords: Edwards Lifesciences, Irvine , Principal Reliability Engineer Irvine Implant Manufacturing, Other , Irvine, California

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