• Develop new and/or improved manufacturing methods utilizing knowledge of product design, fabrication processes, tooling and equipment capabilities, assembly methods and quality requirements
• Assures manufacturing efficiency by analyzing and planning workflow, space requirements and layout of equipment
• Develops shop floor work instructions and trains operators on equipment and methods
• Works directly with equipment/machinery suppliers to develop processes, specifications, capability, and suitability for purpose
• Specifies and purchases equipment and machinery.
• Responsible for the installation of equipment.
• Develops and characterizes new and existing assembly processes.
• Writes and executes IQ, OQ, and PQ validations. Partners with Quality Control department on validation strategy.
• Coordinates drafting, approval and ECO release of MWI’s, drawings, procedures, protocols and reports.
• Integral member of product design teams at early stage product development to assure design for manufacturability
• Provides manufacturing decision-making information by assessing labor and material costs, efficiency, capacity, scrap, etc.
• Assists in mentoring and enhancing skill sets of interns and less experienced engineering staff.
• Assists in transfer or sub-contracting of processes to third parties.
• Experienced in designing efficient work flow to meet production and quality requirements using LEAN manufacturing techniques.
• Stays current on applicable safety and environmental codes and regulations to assure compliance on manufacturing equipment and processes

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• BS degree in Mechanical/Electromechanical Engineering or equivalent engineering degree, or equivalent combination of education and experience.
• Proficient (7+ years) in Automation Engineering involving the electromechanical design, simulation, programming, and fabrication of automated machinery.
• Advanced knowledge of robotics, control systems, instrumentation and the automated control of dynamic processes.
• Experience in selection and/or design of manufacturing equipment, tools and fixtures
• Experience in designing efficient workflow to meet production and quality requirements
• Ability to work effectively with teams and individuals, including assembly personnel
• Skilled in creating/reading technical drawings and specifications
• Excellent technical problem-solving skills
• Excellent written and oral communication skills

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• Experience in the disposable medical device industry, or equivalent technical industry.
• Experience writing and executing Master Validation Plans, Process Risk Assessment (PFMEA), Test Method Validations, and Process IQ/OQ/PQ validations.
• Experience in Six Sigma and LEAN manufacturing

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