This engineer works on a cross-functional Manufacturing Engineering team to support a limited aspect of the consumable manufacturing process. Partners with internal team members to optimize product performance. Performs troubleshooting and routine maintenance of basic manual and automated manufacturing processes under supervision of senior engineers and management. 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 manufacturing engineering problems.
- Supports limited aspect of consumable product manufacturing process
- Works with senior engineers to optimize product performance
- Collects and analyzes data to determine performance of the product under direct 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 basic manufacturing engineering problems
- Makes design and technical recommendations 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, and technical reviews.
- Performs primary duties in a clean room environment.
- Executes validation of new equipment and processes consistent with FDA standards
Training and Education:
- Bachelors in Engineering or related discipline
- Individuals with 10+ years of directly relatable experience (i.e. manufacturing engineering technician, engineering maintenance technician, etc.) may be considered in lieu of degree.
No experience required, candidates with experience in a related field are preferred.
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:
- Familiar with FDA standards
- Process validation
- Thermal characterization
- Vacuum physics
- Heat and mass transfer
Able to safely lift 50 pounds.