The RoleApplies knowledge of technical principles and Edwards systems/procedures to optimize manufacturing processes.Working Hours: Monday to Thursday - 4:30PM - 3AM (Finish at 2AM on Thursdays)How You Will Make An ImpactOptimize manufacturing processes, including using engineering methods (e.g., SIX Sigma and LEAN methods) for continuous process improvement and/or re-design/design of equipment, tools, fixtures, etc. to improve manufacturing processes, employing technical design skillsDevelop moderately complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyse results, make recommendations, and develop reportsAnalyse and resolve moderately 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 processesEstablish project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.)Oversee manufacturing support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician workOther incidental duties assigned by LeadershipWhat You Will Need (Required)Bachelor's Degree in Engineering or Scientific field, 2 years experience Required orMaster's Degree or equivalent with internship, senior projects, or thesis in Engineering or Scientific field including either industry or industry/education RequiredWhat Else We Look For (Preferred)Good computer skills in usage of MS Office Suite including MS Project; CAD experience preferred (if applicable)Good documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skillsBasic understanding of statistical techniquesPrevious experience working with lab/industrial equipment required (if applicable)Solid understanding and knowledge of principles, theories, and concepts relevant to EngineeringSolid problem-solving, organizational, analytical and critical thinking skillsSolid understanding of processes and equipment used in assigned workKnowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturingKnowledge of applicable FDA regulations for medical device industryStrict attention to detailAbility to interact professionally with all organizational levelsAbility to manage competing priorities in a fast paced environmentMust be able to work in a team environment, including the ability to manage vendors and project stakeholdersAbility to build productive internal/external working relationshipsAdhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
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