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.
Job Duties and Responsibilities:
- General: uses experience and education to perform the types of engineering activities which are generally considered within the realm of manufacturing engineering.
- Description: Uses engineering concepts, company SOPs/WIDs, department SOPs/WIDs to solve a variety of difficult engineering problems across functional groups and disciplines.
- Works on: problems of moderate scope and complexity. Generally works on a team with other engineers.
- Influence: receives some oversight from a Senior or Principal Engineer, eligible to be a discipline lead on a project, may provide mentoring for other engineers, and may provide limited department management and leadership.
- Compliance: Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics Quality System.
- Makes design and technical decisions subject to review by Senior, Principal, and other engineers.
- Performs other duties as assigned.
Training and Education:
- B.S. in Engineering or Equivalent
- 3 to 5 years of experience in related field, including performance consistent with said experience.
Knowledge, Skills and Abilities:
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