What are the responsibilities and job description for the Manufacturing Engineer III position at BioFire Diagnostics, LLC?
Description
Internal and External posting
This engineer works on a cross-functional Manufacturing Engineering team to support most
aspects of the biochemical reagent, formulation, and consumable 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
1. Perform all work in compliance with company policy and within the guidelines of BioFire
Diagnostics’ Quality System.
2. Supports most aspects of biochemical reagent, formulation, and consumable product
manufacturing process.
3. Provides direction and oversight of junior engineers.
4. Works with vendors to optimize product performance.
5. Collects and analyzes data to determine performance of the product.
6. Builds relationships both internally and externally as a member of a cross-functional team.
7. Troubleshooting and routine maintenance of manufacturing equipment.
8. Assisting with NCR investigations, write-ups, and product dispositions.
9. Implements best practices and corrective actions.
10. Identifying previously unknown process variables and implementing best practices.
11. Performs FMEA to identify root causes of problems and present possible solutions.
12. Contributes to solving moderate to complex manufacturing engineering and / biochemistry
production problems.
13. Makes design and technical decisions subject to review by Manufacturing Engineering
Manager.
14. Generates variety of technical documentation including WIDs, technical reviews, studies,
and executive summaries.
15. Performs primary duties in a clean room environment.
16. Develops and executes validation of new equipment and processes consistent with FDA
standards.
17. Performs other duties as assigned.
Supplemental Data
Information that will enhance the understanding of the nature of the job (e.g., number of people directly supervised, total staff supervised, sales volume impacted, operating budget, extent of travel required, etc.) 1. Travel : some travel required. 2. Team : usually works on a team with several technicians, engineers and a project manager.
Qualifications
Training and Education
Minimum education and / or training requirements for this position (i.e. high school diploma, college degree,
and / or certification).
Required : Bachelors in Engineering, Bioengineering, Chemistry, Life Science, or Equivalent
Preferred : M.S. or higher in Engineering or related discipline
Experience
Minimum time and type experience required for this position.
7 years of experience in Engineering or related field including performance consistent with said
experience, or 5 years of experience with a master’s degree in engineering, bioengineering,
Chemistry, Life Science, or equivalent.
Knowledge, Skills and Abilities
Knowledge, special skills and / or abilities required to perform the job functions (e.g., negotiation, technical
writing; statistical evaluation).
Skills :
- Manufacturing Engineering Support of Manufacturing, Reagent Production, Quality
control, Process control, and Equipment :
o Failure investigation
o Technical writing; validations, testing plans, root cause investigations, CAPAs,
and NCRs
o Inspection
o GD&T
o Process validation
o Familiar with FDA standards
o PCR chemistry
o Film and plastic bonding and sealing
o SolidWorks
o Sheet metal design
o Materials (e.g. plastics, aluminum, copper, steel, etc.)
o Pneumatics
o Machining (esp. CNC)
o PLC
o Electrical Schematics
o Microfluidics, Tecan Fluent Liquid handling robotic platforms
o Thermal characterization
o SPC
o Oligo synthesis / synthesizers, HPLC, LCMS
o Nucleic acid purification and Lyophilization (freeze-drying)
