This engineer works on a cross-functional Manufacturing Engineering team to support several aspects of the consumable manufacturing process. Partners with internal team members and vendors to optimize product performance. Performs troubleshooting and routine maintenance of basic to moderate manual and automated manufacturing processes. Leverages experience and skillset to implement best practices with the realm of consumable medical device manufacturing by identifying root causes and recommending solutions. Contributes to the resolution of basic to moderate manufacturing engineering problems.Essential Job Duties and ResponsibilitiesPerform all work in compliance with company policy and within the guidelines of BioFire Diagnostics’ Quality System.Supports several aspects of consumable product manufacturing process.Works with senior engineers and vendors to optimize product performance.Collects and analyzes data to determine performance of the product with minimal supervision.Builds relationships both internally and externally as a member of a cross-functional team.Troubleshooting and routine maintenance of manufacturing equipment.Assisting with NCR investigations, write-ups, and product dispositions.Participates on team performing FMEA to identify root causes of problems and present possible solutions.Contributes to solving moderate manufacturing engineering problems.Makes design and technical recommendations subject to review by Manufacturing Engineering Manager.Generates variety of technical documentation including WIDs, technical reviews, studies.Performs primary duties in a clean room environment.Executes validation of new equipment and processes consistent with FDA standardsMakes design and technical decisions subject to review by Senior, Principal, and other engineers.

Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics’ Quality System. Perform other duties as assigned. Perform moderately-complex to complex repairs involving semi-automated and automated manufacturing and /or packaging equipment. Perform moderately complex to complex preventative and scheduled maintenance on semi-automated and automated production equipment, which may include the replacement of failed/broken components (i.e. bearing, belts, motors, etc.), cleaning and lubricating parts, etc. Perform complex troubleshooting activities to identify issues with equipment and use judgment to repair or correct those issues which are often beyond the scope of establish WIDs and documentation. This may include hardware, electrical and PLC systems. Provide emergency support to repair production equipment in order to keep production lines operational at all times. Dismantle defective and /or outdated equipment Build and install new/repaired parts or equipment according to blueprints, specifications, WIDs, and SOPs. Performs some moderately-complex automation tasks, including some work with PLC systems and automation calibration or set up tasks Acts as a departmental subject matter expert to support business needs and objectives beyond standard team activities. Perform off-line mechanical and electrical rework activities.