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Position Summary The Engineering Project Manager is assigned to projects within Reagent Manufacturing. This individual will collaborate with various leaders within manufacturing including operations, engineering, continuous improvement, and other subject matter experts to create project documentation and implement projects on schedule as well as within accordance with design control and QMS requirements. This individual is expected to utilize their engineering expertise on projects assigned and may mentor other Engineers assigned to their projects. In addition to meeting regularly with assigned project resources, this individual is also expected to provide regular project updates to leaders and stakeholders within the organization.

Primary Duties 1. Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics’ Quality System2. Lead Reagent projects with large scope and/or complexity throughout the project lifecycle3. Provides engineering technical guidance for assigned projects 4. Write project plans to document project scope, resources, timeline, risks, and detailed phases5. Create project management deliverables for assigned projects, including developing and maintaining accurate project timelines 6. Oversee the implementation of new or improved manufacturing processes and equipment that deliver value to the Reagent Manufacturing and BMX7. Develop or oversee the creation of risk assessments, specifications, validation plans, protocols, and reports that support the qualification and validation of manufacturing processes8. Effectively lead project teams through identifying, creating, and tracking deliverables in a motivating and collaborative manner to drive the project to completion9. Schedule meetings, create agendas, circulate meeting minutes, facilitate project communications, and deliver presentations 10. Monitor and communicate project performance through periodic reporting11. Create and maintain relevant quality documentation throughout the project12. Apply project management best practices throughout the project lifecycle13. Uses professional concepts in accordance with company objectives to solve complex problems in creative and effective ways. 14. Promote Quality System Regulations (QSR) and regulatory compliance into assigned projects15. Investigate, create, and share new methods and technologies for project advancement16. Effectively tailor project management best practices and processes to assigned projects based on context17. Conduct project risk assessments and determine risk mitigations and responses with the project team

Education and Experience

+ Minimum of Bachelor’s degree in Engineering.

+ Minimum of CAPM Required.

+ PMP is desired.

+ 5 years in project management.

+ Experience in relevant industry may be considered in lieu of project management experience for part, or all required project management experience.

Knowledge, Skills, and Abilities• Knowledge of validation strategies as they pertain to the medical device manufacturing industry• Ability to relate with people at all levels within an organization• Must work well independently as well as effectively in a team environment• Must be able to work on multiple projects simultaneously• Must be an effective and respectful communicator with project stakeholders• Must be able to adapt to changes in projects and priorities with resilience • Ability to manage cross-functional projects and effectively engage with many types of stakeholders, internal and external to Reagent Manufacturing