Manufacturing Engineer II
Want to see more? Find all job opportunities for both BioFire and bioMérieux worldwide by clicking here.
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.
Essential Job Duties and Responsibilities
- Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics’ 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.
- Travel: some travel required.
- Team: usually works on a team with several technicians, engineers, and a project manager.
Training and Education
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.
3 years of experience in related field with a Bachelor’s degree, 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
Able to safely lift 50 pounds.
BioFire Diagnostics, LLC. is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.
Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioFire Diagnostics’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).