Program Manager I

Description

This Program Manager position is within the BioFire Platforms Program team and will work on new product development or lifecycle management projects focused on software for the BioFire Platform.

Program Manager leads projects or program (group of projects) independently and is responsible for the project from project initiation to project closure. PM1 defines, sets up and animates cross functional projects teams including key functions such as R&D, Marketing, Medical Affairs, Clinical Affairs, Regulatory Affairs, Manufacturing, and Purchasing. Managing a project(s) includes leading a cross-functional project meeting (facilitation, presentations and meeting minutes), writing project proposals, plans and other project documentation, tracking project budget, creating and regularly updating project timelines, escalating changes to project scope/timeline/budget within the governance structure, facilitating stakeholder communication, overseeing the design history file, guiding the project team through appropriate processes, and other relevant tasks. Program Manager I will assist the Program Director on long term planning for their projects.

Program Manager I should give detailed attention to project planning, project budget management, project risk management, project cross-functional coordination, stakeholder management and project execution. Program Manager I should have a working knowledge of design control, change control, and risk management as they relate to medical device development and/or production. Program Manager I should be comfortable with public speaking and delegation, developing relationships with cross-functional stakeholders, be able to condense information into a cohesive plan, and be able to effectively communicate and execute plans. PM I should be comfortable in leadership positions, both to guide program stakeholders and to serve as a mentor to others on the team.

Roles & Responsibilities

• Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics' Quality System.
• Independently manage a project and/or program
• Define, set up and animate cross functional projects teams including key functions (such as R&D, Marketing, Medical Affairs, Clinical Affairs, Regulatory Affairs, Manufacturing, and Purchasing)
• Run project meetings independently and present project-related updates to large groups.
• Lead program/project communication to align stakeholders and track goals/milestone
• Own project related tasks, including (but not limited to): writing project proposals, project plans, meeting minutes, timeline updates, budget management, risk management and presentation preparation.
• Budget management:

1. • responsible for estimating costs, setting a budget, and controlling spending.
   • regular financial reporting to stakeholders to provide updates on the project's financial health to maintaining transparency and managing expectations.

• Utilize knowledge of BioFire products, design control, risk management and change control to write project proposals, project plans, design input documentation, schedules, presentations, technical reviews, etc. Maintain project documentation; ensure that appropriate documentation is complete at project close.
• Navigate workflows of other business units/departments to execute a successful project or program.
• Analyze relevant project information (e.g., project status, project issues, etc.); suggest solutions to potential roadblocks.
• Use knowledge of the change control process to assist with impact analyses for changes in assigned program.
• Independently draft risk management plans and/or risk assessments.
• Build relationships with and gain the trust of stakeholders. Gather information on stakeholders' wants/needs. Identify missing points of view in crucial, decision-making conversations.
• Teach and/or mentor other members of the team.
• Navigate design history file (DHF) documentation in an audit.
• Propose new ideas/solutions

Education & Experience

• Bachelor's degree required
  • B.S. in life science, engineering, software or equivalent technical field a plus
• PMP certification a plus
• At least five years of relevant experience. Experience working for a medical device company a plus.

Knowledge, Skills, Abilities

• Advanced knowledge of BioFire products, medical device 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.
• Coachable.
• Confidence without arrogance.
• Ability to understand multiple perspectives.
• Inquisitive and eager to learn.
• Comfortable with ambiguity.
• Proactive.
• Forward thinking.
• Can lead the program team in goal-setting and strategic planning.