"Alerted.org

Position Summary

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 product performance. Performs troubleshooting and routine maintenance of basic to moderate manual and automated manufacturing processes. 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 several aspects of consumable product manufacturing process.

+ Works with senior engineers and vendors to optimize product performance.

+ Collects and analyzes data to determine performance of the product with minimal 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 moderate 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, Principal, and other engineers.

+ 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.

Training, Education and Experience

+ Bachelor’s in engineering or related discipline.

+ 3-5 years of experience in related field with a Bachelor’s degree, or 1-3 years of experience in related with a Master’s degree, and including performance consistent with said experience.

Knowledge, Skills and Abilities

+ Manufacturing Engineering Support of Manufacturing Equipment:

+ CAD/Solidworks

+ Inspection

+ Failure investigation

+ Technical writing

+ Experience with the following is preferred:

+ 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

+ Familiarity with FDA standards

+ SPC

+ Experience with the following is desirable:

+ PLC

+ Microfluidics

+ Thermal characterization

+ Vacuum physics

+ Heat and mass transfer

+ Electrical Schematics

Working Conditions and Physical Requirements

+ Ability to remain in stationary position, often standing, for prolonged periods.

+ Ability to adjust or move objects up to 50 pounds in all directions.