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Position SummaryThe 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 DutiesPerform all work in compliance with company policy and within the guidelines of BioFire Diagnostics’ Quality SystemLead Reagent projects with moderate scope and/or complexity throughout the project lifecycleProvides engineering technical guidance for assigned projectsWrite project plans to document project scope, resources, timeline, risks, and detailed phasesCreate project management deliverables for assigned projects, including developing and maintaining accurate project timelinesOversee the implementation of new or improved manufacturing processes and equipment that deliver value to the Reagent Manufacturing and BMXDevelop or oversee the creation of risk assessments, specifications, validation plans, protocols, and reports that support the qualification and validation of manufacturing processesEffectively lead project teams through identifying, creating, and tracking deliverables in a motivating and collaborative manner to drive the project to completionSchedule meetings, create agendas, circulate meeting minutes, facilitate project communications, and deliver presentationsMonitor and communicate project performance through periodic reportingCreate and maintain relevant quality documentation throughout the projectApply project management best practices throughout the project lifecycleUses professional concepts in accordance with company objectives to solve complex problems in creative and effective ways.Promote Quality System Regulations (QSR) and regulatory compliance into assigned projectsInvestigate, create, and share new methods and technologies for project advancementEffectively tailor project management best practices and processes to assigned projects based on contextTraining and EducationMinimum of Bachelor’s degree in Engineering.
CAPM is desired.Experience3 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 AbilitiesKnowledge of validation strategies as they pertain to the medical device manufacturing industryAbility to relate with people at all levels within an organizationMust work well independently as well as effectively in a team environmentMust be able to work on multiple projects simultaneouslyMust be an effective and respectful communicator with project stakeholdersMust be able to adapt to changes in projects and priorities with resilience

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).