BioFire Diagnostics, LLC. Manufacturing Engineer III (Consumables) - Day Shift in Salt Lake City, Utah
BioFire Diagnostics, LLC. is looking for a Manufacturing Engineer III to join our growing team! This engineer works on a cross-functional Manufacturing Engineering team to support most aspects of the consumable manufacturing process. Partners with internal team members and vendors to optimize product performance. Performs troubleshooting and routine maintenance of moderate to complex 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 moderate to complex manufacturing engineering problems.
Principal Job Duties and Responsibilities:
Supports most aspects of consumable product manufacturing process
Provides direction and oversight of junior engineers
Works with vendors to optimize product performance
Collects and analyzes data to determine performance of the product
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
Implements best practices and corrective actions
Identifying previously unknown process variables and implementing best practices
Performs FMEA to identify root causes of problems and present possible solutions
Contributes to solving moderate to 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.
Develops and executes validation of new equipment and processes consistent with FDA standards
Training and Education:
Required: Bachelor’s Degree in Engineering or related discipline
Preferred: M.S. or higher in Engineering or related discipline
Experience: 7 years of experience in Engineering or related field including performance consistent with said experience, or 5 years of experience with a Master’s degree in Engineering or related discipline.
Manufacturing Engineering Support of Manufacturing Equipment:
Familiar with FDA standards
Experience with the following is preferred:
Film and plastic bonding and sealing
Sheet metal design
Materials (e.g. plastics, aluminum, copper, steel, etc.)
Machining (esp. CNC)
Experience with the following is highly preferred:
Heat and mass transfer
Physical Requirements: Able to safely lift 50 pounds.