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Manufacturing Engineer

Company: Fortive Corporation
Location: Irvine
Posted on: May 3, 2021

Job Description:

The Manufacturing Engineer is responsible for the development, improvement, validation, and support of semi-automated/fully automated manufacturing processes for production of bio-medical products. Scope of responsibility included specifying, procuring, qualifying, troubleshooting, and maintaining equipment needed for processes of mixing, dispensing, and/or packaging biochemical components and/or products. Will also be responsible for introducing new manufacturing technologies (ie hardware and software) to support existing manufacturing processes and equipment; addresses daily technical issues and challenges in production and operations. May lead and/or support technology transfers to international or external manufacturing plants. Initiate continuous improvement opportunities utilizing methodologies; such as Lean/Six Sigma, DFM, SPC, etc. Follows domestic and international regulatory standards (e.g., GMP and ISO 13485). Responsibilities + Develop process windows/limits for manual and automated production processes; + Perform process validations as required, IQ/OQ/PQ; generate protocols and test reports; + Respond to and solve daily technical issues in Irvine manufacturing plant + Disposition Non-conforming materials, determine root cause, and implement corrective action; + Act as technical liaison between R&D Engineering and Manufacturing, + Design, develop, implement, and improve manufacturing processes and equipment + Introduce best in class manufacturing technologies for biological operations + Create user-friendly, pictorial based manufacturing procedures for users and operators + Train lab technicians, and manufacturing operators on processes and procedures + Develop, implement, and support Lean processes in production and throughout operations + Lead/support continuous improvement projects and initiatives + Troubleshoot production line issues and customer complaints related to yield, quality, and throughput. + Lead / Implement robust counter measures and appropriate corrective actions, preventative actions on identified root causes. + Develop Process Failure Mode and Effects Analyses; + Support supplier qualifications and assist in new supplier selection process; + Continuously research, learn, and recommend best practices for world-class biological manufacturing. + Maintain training records and always follow operating procedures. Qualifications + Knowledge of processing, dispensing, and packaging of biochemical products + Knowledge of bio- Medical /Chemical laboratory and with general lab equipment + Knowledge of Process Validation (IQ/OQ/PQ) and able to generate protocols and test reports + Ability to troubleshoot simple to complex manufacturing process issues + Excellent conceptual, analytical, and problem-solving ability + Skilled with data analysis including the use of statistical tools such as Minitab + Excellent communication skills, both verbal and written, and the ability to effectively interface within a cross-functional teams. + Skilled with CAD modeling software such as SolidWorks + Familiar with ISO13485, GMP, or FDA regulated environment is desirable. + Knowledge of continuous improvement methodologies (ie, Lean, Six Sigma, OEE) Education B.S./M.S./PhD in Engineering discipline, Chemical Engineering, Biochemical Engineering, Bio-Medical Engineering, Industrial Engineering, Automation Engineering, or MS/PhD in relevant scientific filed. Fortive (/) is a global family of more than 20 industry-leading industrial growth and technology companies, united by a shared purpose: to make the world stronger, safer, and more effective by providing essential technology for the people who accelerate progress. Here, you get the excitement of a startup with the stability and predictability of an organization strongly grounded in its roots and with a proven track record of growth. Theres no limit to what you can learn, or the impact you can make: for you, for us, for growth. Come join our team at Advanced Sterilization Products (ASP) and be part of a global leader in infection prevention solutions for the healthcare industry. With advanced products, technologies, and workflows for medical sterilization and disinfection, ASP is dedicated to defending the lives of patients, families, healthcare workers, providers, and communities. Add your talent to our extraordinary team and help us in our mission to make healthcare safer for everyone. ASP is based in Irvine, California with core sites in Everett, Washington and Schaffhausen, Switzerland plus many more offices around the world. "The company in which you have expressed employment interest is a subsidiary or affiliate of Fortive Corporation. The subsidiary or affiliate is referred to as a Fortive Company. Fortive Corporation and all Fortive Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, ancestry, sex (including pregnancy, childbirth and related medical conditions), age, marital status, disability, veteran status, citizenship status, sexual orientation, gender identity or expression, and other characteristics protected by law. The "EEO is the Law" poster is available at: ol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf. Individuals who need a reasonable accommodation because of a disability for any part of the employment process should call 1-866-272-5573 or e-mail to request accommodation."

Keywords: Fortive Corporation, Irvine , Manufacturing Engineer, Other , Irvine, California

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