Manufacturing Engineer en bioMérieux

This engineer works on a cross-functional Manufacturing Engineering team to support limited aspects of the consumable manufacturing process. Partners with internal team members to optimize product performance.  Performs troubleshooting and routine maintenance of basic to moderate manual and automated manufacturing processes with guidance from senior engineers and management.  Leverages experience and skillset to implement best practices within 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.

Primary Duties

• Perform all work in compliance with company policy and within the guidelines of bioMerieux’s Quality System.
• Supports limited aspects of consumable product manufacturing process.
• Works with senior engineers to optimize product performance.
• Collects and analyzes data to determine performance of the product with some supervision.
• 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.
• Participates on team performing FMEA to identify root causes of problems and present possible solutions.
• Contributes to solving basic manufacturing engineering problems.
• Makes design and technical recommendations subject to review by Manufacturing Engineering Manager.
• Generates variety of technical documentation including WIDs, technical reviews, studies.
• Performs primary duties in a clean room environment. 
• Executes validation of new equipment and processes consistent with FDA standards
• Makes design and technical decisions subject to review by senior engineers and/or management.
• Performs other duties as assigned. 

Supplemental Data

• Travel: some travel required.
• Team: usually works on a team with several technicians, engineers and a project manager.
• Ability to adjust or move objects up to 50 pounds in all directions.

Training, Education and Experience

• Bachelors in Engineering or related discipline.
• No prior work experience required. Candidates with experience in a related field are preferred. 

Knowledge, Skills and Abilities

• Manufacturing Engineering Support of Manufacturing Equipment:

• Solidworks / CAD
• Inspection
• Failure investigation
• Technical writing

• Experience with the following is desirable:
  • Film and plastic bonding and sealing
  • Filling
  • Sheet metal design
  • Materials (e.g. plastics, aluminum, copper, steel, etc.)
  • Pneumatics
  • Machining (esp. CNC)
  • GD&T
  • Process validation
  • Electrical Schematics
  • Familiarity with FDA standards
  • Microfluidics
  • Thermal characterization
  • Heat and mass transfer
  • SPC