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:
- Failure investigation
- Technical writing
- Process validation
- 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)
- Electrical Schematics
- Experience with the following is highly preferred:
- Thermal characterization
- Vacuum physics
- Heat and mass transfer
Physical Requirements: Able to safely lift 50 pounds.