Description 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 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.
QualificationsTraining and Education
- Perform all work in compliance with company policy and within the guidelines of its 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.
Bachelors in Engineering or related discipline. Individuals with an associate’s degree or equivalent (i.e. Manufacturing Engineering Certificate) and 10+ years of directly relatable experience (i.e. manufacturing engineering technician, engineering maintenance technician, etc.) may be considered. Skills and Qualifications
3 years of experience in related field with a Bachelors degree, including performance consistent with said experience.
- Manufacturing Engineering Support of Manufacturing Equipment:
- Failure investigation
- Technical writing
- 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)
- Process validation
- Electrical Schematics
- Familiar with FDA standards
- Experience with the following is highly preferred:
- Thermal characterization
- Vacuum physics
- Heat and mass transfer
Able to safely lift 50 pounds.