Advanced Manufacturing Engineer 2

1 week ago

Pittsburgh, Pennsylvania, United States Smith+Nephew Full time

OverviewWe are a fast-paced, innovative manufacturing engineering team within Smith+Nephew Robotics working to launch new product development products to our partner manufacturing sites. We are seeking an Advanced Manufacturing Engineer II to help further our company's vision – "Life Unlimited". The successful candidate will be focused on delivering high-quality work on schedule to meet our commitments to the business with the goal of furthering the future of medical technology. This position will be involved in a wide array of activities and projects and interact daily with our Quality, R&D, Product Support and Manufacturing teams and is located in Pittsburgh's thriving Strip District.ResponsibilitiesCreate manufacturing deliverables for New Product Development projects, lead New Product Development effortsCoordinate activities between the NPD and Product Support R&D teams and downstream manufacturing sitesCreate and revise work instructions, BOMs, and routersDesign, develop, construct and implement tools, fixtures, and gagesExecute design transfer process deliverables; capture the voice of the factory in design for manufacturability reviews and design transfer meetingsLead process validation efforts along with quality team support, including authoring and executing protocols as requiredImplement automation as appropriate for siteHelp develop Capital Expenditure requests for new equipment, tooling, and gaugingSelect and qualify equipment and create calibration/preventative maintenance specificationsAnalyze production risk via PFMEA; create process maps and control plansAnalyze highly complex technical manufacturing problems and provide innovative solutionsOwn and respond to CAPA investigationsSupport engineering and prototype builds, actively participate in schedule development efforts for release of new designs to productionSupport development and implementation of functional test solutions for manufacturingMinimum QualificationsEducationBS (MS preferred) in Engineering or related field + 3+ relevant yearsExperienceAt least 2 years' experience in the medical device industry or relevant related industryAt least 2 years' experience working in a manufacturing environment releasing and/or updating productsPreferred QualificationsExperience working on New Product DevelopmentExperience in the medical device industry or relevant related industry; experience with robotics and/or electromechanical products preferredExperience working in a manufacturing environment releasing and/or updating products, as well as troubleshooting complex technical issuesExperience with qualification of plastic, metal, and electronic assembly processesUnderstanding of process validation and the associated regulations (IQ/OQ/PQ)Experience with Design for Manufacturability processesAbility to collect data and utilize Minitab (or similar) to calculate process capability and perform Design of Experiments, Measurement Systems Analysis, and other statistical studiesAbility to design and fabricate simple production fixtures and toolsUnderstanding of Lean/Six Sigma methodologies and toolsKnowledge and understanding of GD&TTravel:

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