Project Manager

About VERO Biotech

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.

Position Summary

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.

Qualifications

• 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%

Desired Qualifications

• 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 PMP certification Competencies 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 Must be a team player 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.