Manufacturing Engineer

Manufacturing EngineerIntegrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.Job DescriptionJob Title: Manufacturing EngineerLocation: Jacksonville, FL Duration: 12+Months (Possibility of extension)Job Role & Responsibilities:This position has the responsibility and authority to support the Manufacturing Engineering group: Develops, refines, maintains and relocate new and existing manufacturing processes, including the creation of manufacturing processing documentation, equipment operating instructions, and product routers.Designs, constructs and maintains assembly fixtures and test equipment.Generates, collects and analyses process data, prepares specifications, and evaluates materials and components.Qualifies and/or validates manufacturing processes and trains production operators.Main Job Duties/Responsibilities – Essential:Designs, develops, and controls projects associated with the development of new, current, or acquired manufacturing processes.Participates in new product project team activity, supporting design for manufacturing elements.Generates, collects and analyses data and prepares specifications, and orders materials and components.Working understanding of Process Verification and Validation, including Validation Master Planning, Installation Qualification, Operational Qualification, and Performance Qualification.Provide engineering support for complex medical devices during their development, product launch, and product lifecycle managementProvide technical oversight for manufacturing production performance, including product yield and cycle time management, and driving continuous improvementsAbility to understand product requirements and establish risk-based production controls through data-driven capability analysis, manufacturing control plans, and product acceptance activitiesWorks with new process development engineering in the evaluation of new processesDrives a Quality focused culture by monitoring compliance to Quality System processes, such as system transaction compliance, documentation practices, non-conforming material, product holds, Line Clearance, etc.Designs, constructs, and maintains assembly fixtures and equipment supporting a Lean manufacturing environment.Ability to understand product requirements and establish risk-based production controls through data-driven capability analysis, manufacturing control plans, and product acceptance activitiesPlans and performs a wide variety of technical tasks to develop robust processes and solve non-routine complex manufacturing problems in an effort to maximize consistency, cost effectiveness, and productivity.Assist in project planning and budgeting.Collaborates in the design of all special production machinery (jigs, tools, fixtures, machines, and handling equipment) to maintain manufacturing operations at competitive levelsReviews process yields and tracts defects with the Quality Department against cost of qualityPartners with other departments to ensure that the manufacture and purchase of components meet functional requirements at the lowest possible costsLimited travel will be required.Complies with the Healthcare Site Quality System.Performs duties in compliance with environmental, health and safety related site rules, policies or governmental regulations.Required to interact and communicate with peers and co-workers.Required to spend extended periods of time on computer-based work.Performs other duties as assigned.Basic Qualifications – Education:Bachelor of Science in Electrical Engineering, Mechanical Engineering or similar relevant discipline required.Master of Science in Electrical Engineering, Mechanical Engineering or similar relevant discipline preferredYears of Experience:Minimum of 4 years of experience in a medical device (aerospace or equivalent) manufacturing environmentSkills and Qualifications:Experience in medical product manufacturing/assembly operations is a plusDemonstrated Project Planning and execution experience on major projectsGreen Belt Certification2 years of Lean Sigma Project Execution experience.Demonstrated Project Planning and execution experience on major projects.Kaizen facilitation experienceStrong interpersonal SkillsExperience comprehending quality system process documentsExperience interpreting mechanical drawingsExperience understanding proper documentation/quality requirements for a regulated environment is a plusAptitude for quickly learning and assimilating a broad array of informationExcellent data analysis skills, and proficient in the use of statistical tools in problem solvingUnderstanding of development validation