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 Program Manager!
BioFire Diagnostics, LLC. is looking for a Program Manager I to join our growing team!
Program Manager II (PM II) manages multiple suites of projects (called “programs”) related to product development and/or production. This role requires an exceptional level of strategic thinking to direct long-term program planning. Managing a program includes drafting/organizing documentation, overseeing the design history file, running a weekly program meeting, prioritizing projects and goals on behalf of a larger group, regularly updating timelines to track goals and milestones, facilitating stakeholder communication, guiding the program team through the change management process, and other relevant tasks. PM II should have an advanced knowledge of design control, change control, and risk management as they relate to medical device development and/or production.
PM II should have experience in leadership positions. This experience is necessary to guide program stakeholders and to serve as a mentor to others on the team. PM II will work closely with junior members of the program management team and should be adept at delegation and mentorship.
Essential Job Duties and Responsibilities
- Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics’ Quality System.
- Manage program communication to align stakeholders and track goals/milestones.
- Run program meetings independently, assist others in running successful program meetings.
- Present program-related updates to large groups and executive groups.
- Own and delegate program-related tasks, including (but not limited to): meeting minutes, timeline updates, and presentation preparation.
- Utilize knowledge of BioFire products, design control, risk management and change control to draft project proposals, design input documentation, project plans, schedules, presentations, technical reviews, etc., and review these types of documents for other members of the team.
- Analyze relevant project information (e.g., project status, project issues, etc.), proactively brainstorm and implement solutions to potential roadblocks.
- Maintain documentation; ensure that appropriate documentation is complete at project close.
- Communicate with program stakeholders to assess and meet program milestones.
- Champion the change control process when managing product changes in a program setting.
- Draft risk management plans and/or risk assessments. Assist others in drafting their risk management plans and/or risk assessments.
- Build relationships with (and maintain the trust of) program stakeholders.
- Gather information on program stakeholders’ wants/needs.
- Independently manage multiple large/complex programs.
- Teach and/or mentor other members of the team.
- Navigate design history file (DHF) documentation in an audit (without guidance).
- Navigate workflows of other business units/departments to execute a successful project or program.
- Collaborate with program team to determine what the future of the program looks like, including goals and milestones. Use this information to create a five-year program or portfolio plan.
- Own multiple of the following: project plans, design change notices (DCNs), and technical reviews.
- Contribute to portfolio and company strategic plan.
- Escalate issues in program to executive-level when necessary.
- Independently generate (or maintain a significant portion) of the product's DHF.
- Negotiate with other departments to align divergent visions.
- Pursue growth opportunities for assigned program(s).
- Regularly review colleagues' documents and coach verbal communication.
- Proactively consider plans for training, onboarding, mentorship, and development.
- Seek out or creates development opportunities for others on the team.
Training and Education
Bachelor’s degree required; B.S. in life science, engineering, or equivalent technical field a plus. Relevant advanced, technical degree, MBA, and/or PMP certification from the Project Management Institute is a plus.
At least seven years of project or program coordinator/management experience. Experience working for a medical device company a plus.
Knowledge, Skills and Abilities
Applicants should address any relevant experience in a well-written cover letter to accompany their application.
- Expert knowledge of BioFire products, design control, risk management, and change control.
- Self-motivated, and able to manage time effectively.
- Can effectively work as part of a team, and supports the team with a helpful attitude.
- Clear and transparent verbal and written communication.
- Critical listening skills, and an ability to recognize important and high-level information.
- Ability to stay positive and calm in stressful situations.
- Ability to adjust to changes in scheduling, and general flexibility in the work environment.
- Organization and extreme attention to detail.
- Ability to complete work quickly and efficiently.
- Critical and innovative thinker.
- Confidence without arrogance.
- Ability to understand multiple perspectives.
- Inquisitive and eager to learn.
- Comfortable with ambiguity.
- Forward thinking.
- Can lead the program team in goal-setting and strategic planning.
- Strong understanding of how programs fit into the larger portfolio.