Our Mission: At VERO Biotech, our mission is to improve the lives of patients by developing innovative technologies that support critical care and respiratory therapy through inhaled nitric oxide delivery in the acute care hospital setting or wherever nitric oxide treatment is needed.
We strive to exceed customer expectations in terms of safety, efficacy, and value by focusing on the science, development, and commercialization of our innovations.
The role is a highly organized, execution-oriented Project Manager to support critical business initiatives, including New Product Development (NPD), Business infrastructure, manufacturing and Quality programs.
This role requires foundational experience in medical device development and is ideal for project managers that thrive in a fast-paced, cross-functional environment. The successful candidate will support planning, coordination, and documentation activities across R&D, Regulatory, Quality, Operations, and Commercial teams.
This individual will play a critical role in ensuring timelines, deliverables, and design control requirements are met while building strong cross-functional alignment.
Essential Duties and Responsibilities
Program Execution and Coordination:
Support of multiple concurrent, critical programs across various phases
Maintain detailed project plans, Gantt charts, and milestone tracking tools
Track risks, action items, and dependencies across cross-functional teams
Prepare and distribute program dashboards and executive level updates
Strong communication skills and positive influence on the team quality and execution
Design Control and Regulatory Support
Support adherence to FDA design control and change control requirements
Assist with maintenance of Design History Files
Coordinate inputs for regulatory submissions
Track testing progress for V&V, human factors and usability testing, biocompatibility, etc.
Support traceability matrix updates and requirement tracking
Cross-Functional Alignment
Coordinate across Engineering (hardware, software, systems), Clinical, Regulatory Affairs, Quality, Operations / Manufacturing, Supply Chain, Finance, and Commercial
Escalate timeline risk and resource constraints early
Help ensure proper stakeholders are integrated into product development planning
Documentation and Process
Maintain program documentation repositories
Assist in preparing leadership summaries and board level materials
Drive continuous improvement in program management
Collect data and provide routine reporting on operational metrics and key performance indicators.
Serves as a promoter of the program management processes and initiatives and assists company resources in the practice of these initiatives.
Other duties as assigned by the manager.
Bachelor’s degree in Engineering, Life Sciences, or related technical field
2-5 years of experience in Medical Device development and technical project coordination
Basic understanding of FDA Design Controls, Verification and Validation processes, Change Control, and Risk Management
Excellent written and oral communication skills.
Strong organizational and problem-solving skills.
Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm.
Acute attention to detail
Proven ability to handle multiple projects and meet deadlines.
Strong knowledge of Microsoft Office (Excel, PowerPoint, etc.) as well as Project Management applications
Ability to travel up to 25%
Experience with agile and waterfall delivery environments.
Experience supporting regulatory submission in combination products or respiratory/critical care devices.
proven ability to work cross-functionally and act as a liaison between technical and business focused teams
Execution discipline and follow-through
Systems thinking and prioritization
Clear communication and escalation
Cross-functional collaboration
Data-driven decision support
Accountability and ownership
Comfortable in a fast-paced environment handling multiple tasks and projects
Able to organize and manage large amounts of files, tasks, schedules, and information
Self-directed and able to work without supervision
Energetic and eager to tackle new projects and ideas
Comfortable interacting with individuals at all levels of the organization and across multiple sites
Physical Demands and Work Environment
Standard office and laboratory environment
Periodic hands-on engagement in lab or manufacturing settings
Occasional travel for customer visits, testing, supplier engagement, or regulatory meetings
The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or physical requirements. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.