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Manufacturing Engineer II

Company: Aerotek
Location: San Diego
Posted on: April 9, 2021

Job Description:

Description:SUMMARY: This position will be responsible for support of on-going commercial production activities by providing technical leadership to optimize, improve and upgrade our manufacturing processes. Lead process sustaining, definition and improvement, design, development, and quality test activities in the making of our products or support of processes/equipment. Additionally, be responsible for the design, validation, and implementation of automation, fixtures, and processes needed for the production manufacture of point-of-care, in-vitro diagnostic instruments and disposable test cassettes. This position requires relevant experience, proficiency in Solid Works 3D Design, and experience working under FDA QSR/ISO 13485 environment.RESPONSIBILITIES:Assist in the evaluation of the manufacturing processes by designing and conducting research; applying knowledge of product design, fabrication, assembly, tooling, and materials; conferring with equipment vendors; soliciting observations from operatorsInvolvement with the engineering team for identifying the most effective production process and guidelinesDevelop manufacturing processes by studying product requirements; researching, designing, modifying, and testing manufacturing methods and equipment; conferring with equipment vendorsAssist in Improving manufacturing efficiency by analyzing and planning workflow, space requirements, and equipment layoutAssure product and process quality by designing testing methods; testing finished- product and process capabilities; establishing standards; confirming manufacturing processesProvide manufacturing decision-making information by calculating production, labor, and material costs; reviewing production schedules; estimating future requirementsPrepare product and process reports by collecting, analyzing, and summarizing information and trendsBe assigned with various other tasks that need to be completed along with the Engineering projectsProvide manufacturing engineering information by answering questions and requestsKeep equipment operational by coordinating maintenance and repair services; following manufacturer's instructions and established procedures; requesting special serviceMaintain professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies.Contributes to team effort by accomplishing related results as neededImplementation and integration of automation systemsProduction scale-up from manual, to semi-automated and fully automated solutionsDesign verification and validation per ISO 13485Skills:Manufacturing engineering, Process improvement, Six sigma, Process engineering, Lean manufacturing, Manufacturing process, Continuous improvement, automationTop Skills Details:At least 10 years of experience in the development and/or manufacture of IVD/Medical devicesExperience with programmable logic controllersExperience with machine vision systemsExperience in the integration of automated production systemsAdditional Skills & Qualifications:EDUCATION/EXPERIENCE REQUIRED: BS in Mechanical Engineering, Industrial Technology, or other relevant Engineering discipline3-5 years' experience working in FDA and ISO 13485 regulated companyWorking knowledge of 13485:20163-5 years previous Manufacturing Engineering experience and cGMP and/or CLIA laboratory experience3-5 years' experience in biotech / IVD / Medical DeviceExperience with medical device manufacturing processes qualification (IQ/OQ/PQ)Product manufacturing, inspection, and testing experience All development activities will meet or exceed ISO 13485 design control and risk assessment requirementsHigh level problem solving, and reasoning skillsExperience with product development processes and project management skills Experience in production support and/or process development Experience with statistics, Statistical Process Control and DOE techniquesExperience Level:Intermediate Level About Aerotek:We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Keywords: Aerotek, San Diego , Manufacturing Engineer II, Other , San Diego, California

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