Position Description :

　　This engineer works on a cross-functional Manufacturing Engineering team to support several aspects of the consumable manufacturing process. Partners with internal team members and vendors to optimize manufacturing and product performance. Performs troubleshooting and routine maintenance of basic to moderate 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 basic to moderate manufacturing engineering problems.

　　Job Title Manufacturing Engineer II (Consumables – Biochemistry/Formulation)

　　Direct Supervisor Manufacturing Engineering Manager

　　Description of Responsibilities

　　Job Summary

　　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

　　Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics’ Quality System.

　　Supports most aspects of biochemical reagent, formulation, 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 and / biochemistry production problems.

　　Makes design and technical decisions subject to review by Manufacturing Engineering Manager.

　　Generates variety of technical documentation including WIDs, NCRs, 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.

　　Qualifications: Training and Education

　　Minimum education and/or training requirements for this position (i.e. high school diploma, college degree, and/or certification).

　　Required: bachelor’s 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.

　　5 years of experience in Engineering or related field including performance consistent with said experience, or 2 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:

　　Failure investigation

　　Trouble shooting and repair of production equipment and instrumentation.

　　Technical writing

　　Inspection

　　Process validation

　　Familiar with FDA standards

　　Nucleic acid chemistry

　　Experience with the following is preferred:

　　GD&T

　　Film and plastic bonding and sealing

　　Solidworks

　　Sheet metal design

　　Materials (e.g. plastics, aluminum, copper, steel, etc.)

　　Pneumatics

　　Machining (esp. CNC)

　　PLC

　　Electrical Schematics

　　Experience with the following is highly preferred:

　　Trouble shooting and repair of reagent production equipment and instrumentation used in olgio synthesis and PCR chemistries. (liquid handling robots, HPLCs, GCMSs, oligo synthesizers, Lyophilizers, labelers, and tube and plate sealers etc.)

　　Thermal characterization

　　SPC

　　Nucleic acid purification and characterization

　　Physical Requirements:

　　Able to safely lift 50 pounds.