At BioFire Diagnostics, LLC. we make the world a healthier place by providing molecular solutions that lessen the time to medical results and empower healthcare professionals to make better diagnostic decisions.
We are proud to be part of the bioMérieux family and the 5,000+ team members across 12 sites and subsidiaries in North America committed to our mission to help save lives around the globe through the power of diagnostics.
Come be a part of our team and our mission as a Project Manager!
BioFire currently has Project Manager opening(s) in the Technology Transfer department on the following team(s):
- Instrument Development, Sustainment, and Reliability. Project managers work closely with our engineers, instrument manufacturing team, and program managers leading change control and project management activities related to our FilmArray 2.0 and Torch and other benchtop medical diagnostic equipment.
- Reagents & Consumables. Project managers work closely with our scientists, engineers, reagent manufacturing team, and program managers leading change control and project improvement activities related to new consumable product development and existing diagnostic products.
At BioFire, Technology Transfer Project Managers work with some of the most innovative and dedicated scientists and engineers in the medical device industry!
Project Managers on all Technology Transfer teams facilitate the transfer, sustainment, and improvement of products and processes from research and development to a final product ready to send to customers. They ensure changes are documented and maintained according to regulatory standards and quality system requirements. They do this by collaborating with research and development in both chemistry and engineering, program management, supply chain, purchasing, materials management, quality assurance, software, service, reagent and instrument manufacturing, labeling, marketing, and regulatory departments to ensure that all changes are properly understood and documented appropriately within the guidelines of BioFire Diagnostics’ quality management system (QMS).
Primary responsibilities include:
- Lead and monitor multiple projects throughout the project lifecycle
- Write, revise, and present change notifications, change orders, protocols and reports, work instruction documents, standard operating procedures, qualifications, product specifications, and verification and validation plans
- Develop and maintain timelines, schedule meetings, create agendas and presentations, facilitate discussions, and document meeting minutes and action items
- Adhere to BioFire’s Change Control Process and Quality Management System to identify the associated impact, risk, and testing
- Collaborate with other departments and stakeholders to ensure transfer projects and activities are scoped and completed on schedule
The ideal candidate must have:
- Bachelor’s degree in relevant scientific or engineering field
- A minimum of three years of relevant work experience
- Three or more years of experience in ISO 900, 13485 and/or cGMP/cGLP compliant environments, including manufacturing, medical device, or regulated environments, are preferred
- A minimum of two years of project management or related experience
- Relevant MBA and/or PMP certification from Project Management Institute a plus
- Ability to work in a fast-paced and dynamic environment
- Strong analytical and problem-solving skills
- Excellent communication skills -- verbal, written, and presentation