At BioFire Diagnostics, LLC. we make the world a healthier place by providing molecular solutions that lessen the time to medical results and empower healthcare professionals to make better diagnostic decisions.
We are proud to be part of the bioMérieux family and the 5,000+ team members across 12 sites and subsidiaries in North America committed to our mission to help save lives around the globe through the power of diagnostics.
Come be a part of our team and our mission as a Manufacturing Engineer!
This engineer works on a cross-functional Manufacturing Engineering team to support most aspects of the biochemical reagent and formulation 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.
Essential Job Duties and Responsibilities
- Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics’ Quality System.
- Supports most aspects of reagent and 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/biochemistry 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: Bachelor’s in Engineering, Bioengineering, or related discipline
Preferred: M.S. or higher in Engineering or related discipline
Minimum of 7 years of experience in Engineering, Bioengineering, or related field including performance consistent with said experience, or 5 years of experience with a master’s degree in Engineering, Bioengineering, or related discipline.
Knowledge, Skills and Abilities
- Manufacturing Engineering Support of Manufacturing Reagent Processes and Equipment:
- Failure investigation
- Technical writing
- Process validation
- Familiarity 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:
- Automated fluidic handling robotic platforms
- Biochemical process design
- Nucleic acid extraction and oligo synthesis chemistry
- GC/MS, LC/MS instrumentation
Able to safely lift 50 pounds.