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Description

Position Summary & Responsibilities:

The Principal Engineer, Reagent Engineering will work within the Reagent Engineering Equipment Project team. This team is responsible for the manufacturing equipment used to produce a complex medical device and provides project management and technical expertise related to the manufacturing equipment.     

Main accountabilities are to lead and manage equipment related projects and to provide Solidworks / AutoCAD expertise related to equipment design / modification.Act as administrator for Solidworks PDM system. Develop documentation such as equipment master records, equipment drawings, parts lists, etc. as required.Manage change control process and other compliance related documentation for projects. Collaborate with Manufacturing, Purchasing, and Quality to lead projects and ensure the optimum manufacturing process in terms of keeping manufacturing moving. Organize and lead meetings as required to support project timelines. Develop and submit CAPEX requests for projects when required. Address unplanned requests for Engineering support as directed by management. Support projects or tasks required to keep manufacturing running and to ensure quality product is being shipped to customers.Evaluate new technologies. Participate in the development of long-term strategies for equipment and process improvements. Drive continuous improvement of manufacturing equipment.

Education, Skills, & Experience: 

Bachelor’s Degree in a technical field with8+ years of engineering experience preferred.High School Diploma with 12+ years of engineering experience also acceptedTechnical Certification / Associates Degree with 10+ years of engineering experience also accepted Masters Degree with 5+ years of engineering experience also accepted5+ years of experience working with automated processes and machinery.Must have strong ability to use Solidworks / Autocad programs. Solidworks PDM experience is preferred. Project Management experience is preferred. Ability to collaborate professionally in a cross-functional team environment.Knowledge of FDA/ISO regulations and equipment validation is preferred. Strong Knowledge of Microsoft Office (Word, Excel, PowerPoint, and Outlook).Must have strong communication and interpersonal skills.Must have strong analytical and problem-solving skills. #LI-US
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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).