Quidel Corporation is a leading manufacturer of diagnostic healthcare solutions serving to enhance the health and well being of people around the globe with well known and respected products that provide healthcare professionals with accurate and cost-effective diagnostic information at the point of care (POC). Our core competencies and capabilities focus on immunoassay and molecular testing in the areas of: infectious disease, women’s health, and virology.
Quidel is searching for a Manufacturing Engineer to work at our Sorrento Valley location in San Diego. The Manufacturing Engineer will support manufacturing operations in the production of diagnostic systems. Driving continuous improvement of product and process quality, activities will include troubleshooting issues, historical data analysis, test design, documentation, and the implementation/validation of automated assembly equipment and process changes. Individual will work closely with development engineering during the design of new products in an effort to optimize manufacturability, cost, time to stability, and the development of manufacturing documentation (specifications, drawings, instructions, etc.). Specific roles and responsibilities include the following:
Identify and implement efficiency improvements impacting process yields
New Equipment acquisition
Integrity of Manufacturing Instructions (MI’s)
Efficiency and process improvements of Manufacturing Routings and BOM’s
Equipment status, operating condition, and operating procedures
Process troubleshooting, and improvement activities
Write and execute validation protocols (related to process and equipment efficiencies)
Generate documentation for production operations including Bill of Materials (BOMs), Engineering Change Orders (ECOs), manufacturing and equipment instructions, validation protocols, design control, pFMEA, and control plans.
Apply engineering techniques to sustain and maximize current manufacturing efficiencies and product supply. Areas include: wet chemistry processing and filling, automated and manual assembly, plastic injection molding.
Identify and implement new technologies and continuous improvement to optimize manufacturing process output. Develop and maintain Manufacturing Instructions, SPC, Routings and Bill of Materials.
Develop training protocols and assist in operator training
Provide engineering guidance for cross-functional project teams functioning at either the team leader or team member capacity.
Develop and implement MFG documentation for changes related to materials, process, and product
Monitoring of equipment set-ups, documentation, and operating parameters
Education and Experience:
B.S. degree in an engineering discipline, preferably Mechanical, Manufacturing or Control and Automation Engineering. Three to seven years plus experience in device manufacturing, pharmaceutical or medical device environment preferred.
Show proficiency in PLC´s and Control Logix AB products
Strong knowledge of Industrial Networks
Strong knowledge of Human Machine Interface (Panelview, FTView and others)
Working knowledge of vision systems to inspect, identify and guide parts (Keyence, Cognex and others)
Strong Knowledge of MS Office Tools and Visio
Working knowledge and understanding of statistics, DOE methodology, gauge R&R, Cpk.
Prefer experience in Electrical-Mechanical Theory & Application, Process and Assembly Automation, 3D CAD, Hardware Design, Pneumatics, Instrumentation, PLC and Machine Programming, Basic Finance Theory, advanced problem solving, excellent written skills.
Strong working knowledge of plastic injection molding, design, and manufacturing,
Working knowledge of SolidWorks, GD&T, ASME Y14.5 standards.
Experience working in medical device or other FDA regulated environment is preferred but not required.
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