This engineer works on a cross-functional Manufacturing Engineering team to support all aspects of the consumable manufacturing process. Partners with internal team members and vendors to optimize product performance. Performs troubleshooting and routine maintenance of 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 complex manufacturing engineering problems.
- Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics’ Quality System.
- Supports all aspects of consumable product manufacturing process.
- Works with vendors to optimize product performance and recommend new technologies.
- Mentors, directs, and oversees junior engineers.
- Collects, analyzes, and reporting of data to determine performance of the product.
- Builds relationships both internally and externally as a member of a cross-functional team.
- Troubleshooting and 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 complex manufacturing engineering problems.
- Makes design and technical decisions subject to review by Manufacturing Engineering Manager.
- 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.
- Performs other duties as assigned.
- Travel:some travel required.
- Team: usually works on a team with several technicians, engineers and a project manager.
Training and Education:
Required: Bachelors in Engineering or related field
Preferred: Masters or higher in Engineering or related field
10+ years of experience in Engineering or related field including performance consistent with said experience
Preferred: Previous experience leading technical teams
Skills and Qualifications:
Manufacturing Engineering Support of Manufacturing Equipment:
- Failure investigation
- Technical writing
- Process validation
- Familiar with FDA standards
Experience with the following is preferred:
- 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
Able to safely lift 50 pounds.