ICU MEDICAL INC Sr. Manufacturing Engineer in TAYLORSVILLE, Utah

Job Title Senior Manufacturing Engineer FLSA Status Exempt Position Summary The Senior Manufacturing Engineer will support the ICU Manufacturing Engineering Department and report to the Manufacturing Engineering Manager. The Senior Manufacturing Engineer is responsible for owning and driving process improvements through adherence to established design control processes and through good engineering and documentation practices. The key responsibility of this position is to exercise judgement and take action while adhering to defined procedures during project support & improvements. Essential Duties & Responsibilities Functional area tasks and responsibilities Day to day Initiate and manage projects with adherence to program-management guidelines Identify assembly process variation; propose and implement viable corrective actions. Must be multi-task oriented. Own and manage CAPA tasks and deliverables (Corrective and Preventive) Lead vendor assessment and review of materials-machine technical information Design small fixtures for inspection, tooling details for machines, and reverse engineering. Identify and implement process and product modifications to improve manufacturability and impact on automation equipment Consult with Product and Molding Engineers on in-process non-conformances Process technical expert for multiple manufacturing production lines Create and edit documents to support Production Work with Quality Engineers on qualification activities for new or modified processes and equipment (IQ-OQ-PQ) Long term expectations Spearhead initiatives for continuous process improvements Develop a broad understanding from start to end of the product manufacturing process in the company Perform design assessments, active participation in design reviews and risk management processes Network with senior internal and external personnel Knowledge, Skills & Qualifications Substantial knowledge in one or more key process areas: automation, medical-device assembly, controls, etc. Understanding of strength of materials, plastic injection molding, fixturing, testing, and process control techniques Having wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways. Six-Sigma Methodology (DOE, Process Capability, Gage R&R, etc.) and advance statistical skills Understanding of plastic injection molded parts, extrusion, and an insert-molding process is desired Independently work on complex problems; drive and implement solutions Knowledge of the Medical Device Industry and familiarity with FDA QSR regulations Proficiency in SolidWorks required. Determines methods and procedures on new assignments and may coordinate activities of other personnel Technical writing competency . Education and Experience Bachelor's degree in Engineering or Technology. MS is preferred. Medical Device Experience is a must 6 years combined experience in the Medical Device or Engineering Industry Advanced Degree may substitute for experience Minimum Qualifications Must be 18 years of age Must pass pre-employment drug screen and background check Travel Requirements Typically requires travel less than 5% of the time Physical Requirements and Work Environment While performing the duties of this job, the employee is regularly required to talk or hear This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines Work is performed in a clean room environment While performing the duties of this job, the employee may be required to sit or stand for long periods of time Must be able to occasionally move and lift objects of up to 25 lbs We are an Equal Employment Opportunity Employer, Female-Minority-Veterans-Di