- 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
Experience : 10+ years of experience in Engineering or related field including performance consistent with said experience.
Preferred: Previous experience leading technical teams
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