Position Summary:

　　The AME works on a cross-functional team to support all aspects of the consumable manufacturing process. Partners with internal teams and vendors to optimize product & equipment performance. Leverages experience in Automation and skillset to implement best practices within the realm of consumable medical device manufacturing by identifying root causes and recommending solutions. Contributes to the resolution of complex manufacturing engineering problems, with emphasis on automated equipment.

　　Principal Job Duties and Responsibilities:

　　Supports automation aspects of consumable product/reagent manufacturing process.

　　Works with vendors to optimize equipment performance and recommend new technologies.

　　Builds routines, collects, and analyzes data reporting to determine performance of the product and equipment.

　　Works with/on MES software, Automation PLC packages to support equipment and Manufacturing Engineering teams in production.

　　Builds relationships both internally and externally as a member of a cross-functional team.

　　Troubleshooting and maintenance of automated manufacturing equipment.

　　Assisting with NCR investigations, write-ups, and product dispositions.

　　Identifying previously unknown process variables and implementing best practices.

　　Supports with and sometimes performs FMEA to identify root causes of problems and present possible solutions.

　　Contributes to solving complex manufacturing engineering problems.

　　Makes design and technical decisions subject to review by Manufacturing Engineering Manager.

　　Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics’ Quality System.

　　Generates variety of technical documentation including WIDs, technical reviews, studies, and executive summaries.

　　Performs primary duties in a clean room environment.

　　Support in development and execution of validation of new equipment and processes consistent with FDA standards.

　　Act as a representative of Automation Manufacturing Engineering with emphasis on sustainment in new automation/equipment development efforts.

　　Provide on call support, as assigned, to all reagent manufacturing areas.

　　Supplemental Data:

　　Travel: some travel required.

　　Team: usually works on a team with several technicians, engineers, project manager, and automation development engineers.

　　Qualifications

　　Training and Education:

　　Required: Bachelors in Engineering or related discipline

　　Preferred: M.S. or higher in Engineering or related discipline

　　Individuals with an Associates degree with significant years (5+) of experience in specific automation engineering support role may also be considered.

　　Experience:

　　3+ years of experience with Bachelors in supporting Automation/equipment in high volume manufacturing, preferably in a regulated industry or an entry level Master’s degree in related discipline.

　　Skills:

　　PLC programming

　　Electrical Schematics

　　Technical writing

　　Failure investigation

　　Equipment and Process Validation

　　SCADA Systems

　　Experience with the following is preferred:

　　Solidworks

　　Pneumatics

　　Non-conformance Reporting

　　FDA & regulatory standards

　　Six Sigma/Lean – Continuous Improvement

　　Experience with the following is strongly preferred:

　　Onboarding OEM equipment

　　HMI development

　　Robotics programming

　　Machine vision

　　Studio 5000

　　Multi-axis motion control

　　SPC

　　Physical Requirements:

　　Able to safely lift 50 pounds.