• 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 #LI-US

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