Program Manager I (PM I) oversees the fulfillment of larger organizational goals in a highly technical environment. They manage a program, giving detailed attention to program strategy, project delegation, and program implementation. They coordinate activities between multiple projects without directly managing them. PM I guides all of the projects – and project managers – housed within one program.
Managing a program includes drafting/organizing documentation, overseeing the design history file, running a program meeting, prioritizing projects and goals, 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 I is competent in design control, change control, and risk management as they relate to medical device development and/or production.
PM I is comfortable in leadership positions, both to guide program stakeholders and to serve as a mentor to others on the team. PM I may work closely with a project coordinator or less experienced team member and should be adept at delegation and mentorship.
- 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.
- 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.
- Utilizes 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.
- Analyze relevant project information (e.g., project status, project issues, etc.), brainstorm and implement solutions to potential roadblocks.
- Maintain documentation; ensure that appropriate documentation is complete at project close.
- Communicate with program stakeholders to set, assess, and meet program milestones.
- Facilitate and champion change control efforts in assigned program.
- Independently draft risk management plans and/or risk assessments.
- Build relationships with (and gain the trust of) program stakeholders.
- Gather information on program stakeholders’ wants/needs.
- Independently manage a large/complex program.
- 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 (ensure the needs of other departments are met in this process).
- Own multiple of the following: project plans, design change notices (DCNs), and technical reviews.
- Facilitate collaboration across teams to integrate business goals with program goals.
- Identify missing points of view in crucial, decision-making conversations.
- Proactively considers plans for training, onboarding, mentorship, and development.
Training and Education
- Bachelor’s degree required
- B.S. in life science, engineering, or equivalent technical field a plus
- Relevant advanced technical degree or MBA a plus
- PMP certification a plus
At least five years of project or program management experience. Experience working for a medical device company a plus.
Knowledge, Skills, and Abilities
- Advanced 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.