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
- Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics’ Quality System
- Lead Reagent projects with moderate scope and/or complexity throughout the project lifecycle
- Provides engineering technical guidance for assigned projects
- Write project plans to document project scope, resources, timeline, risks, and detailed phases
- Create project management deliverables for assigned projects, including developing and maintaining accurate project timelines
- Oversee the implementation of new or improved manufacturing processes and equipment that deliver value to the Reagent Manufacturing and BMX
- Develop or oversee the creation of risk assessments, specifications, validation plans, protocols, and reports that support the qualification and validation of manufacturing processes
- Effectively lead project teams through identifying, creating, and tracking deliverables in a motivating and collaborative manner to drive the project to completion
- Schedule meetings, create agendas, circulate meeting minutes, facilitate project communications, and deliver presentations
- Monitor and communicate project performance through periodic reporting
- Create and maintain relevant quality documentation throughout the project
- Apply project management best practices throughout the project lifecycle
- Uses 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 projects
- Investigate, create, and share new methods and technologies for project advancement
- Effectively tailor project management best practices and processes to assigned projects based on context
Training and Education
Minimum of Bachelor’s degree in Engineering.
CAPM is desired.
Experience
3 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
