Project/Program Manager

The Manager, Project/Program Management is responsible for successfully leading project and program teams through various stages of product development, clinical evaluations, operational readiness, and commercialization for new and improved products, including related accessories and disposables. This role involves initiating, planning, budgeting, executing, documenting, controlling, and managing all aspects of projects and programs to ensure on-time commercialization of new products and technologies while upholding Clients best-in-class quality standards and business objectives.

• Manage one or more large-scale projects and/or programs, ensuring strict adherence to Clients Quality Systems and Change Control Process.

• Facilitate the creation and approval of business cases within the program and coordinate the sharing and prioritization of resources among projects.

• Develop detailed program plans and manage program changes accordingly.

• Implement program strategies related to quality assurance, risk management, communications, staffing, and other core areas, and communicate program status and data to ensure accurate and current information for stakeholders.

• Facilitate core team meetings and other required meetings to support program execution; regularly assess and improve meeting processes, decision-making, and workflows.

• Serve as a project and program management subject matter expert, providing guidance and mentoring to peers.

• Demonstrate high emotional intelligence by building trust, rapport, and respect with project team members and stakeholders, and engaging in honest and transparent communication.

• Create a culture of urgency and accountability to meet or exceed individual and project goals.

• Understand complex problems and drive teams toward effective resolution.

• Display perseverance and maintain appropriate forward momentum by keeping core teams engaged during crises and periods of change.

• Demonstrate a strong ability to influence across all levels of the organization, including downward, Clienttally, and upward.

• Minimum of 6 years of direct experience managing N ew Product Development projects and/or programs of increasing complexity.

• Demonstrated success in managing and leading projects in the medical device industry involving a mix of Software, Firmware, Thermoplastic Hardware, and Disposable components.

• Proficient understanding of Medical Device Regulations and the Product Development Process.

• Proven record of leadership within complex organizations, requiring strong management skills.

• Expertise in the use of MS Office Suite and related project management systems.

• Ability to see the big picture and determine the best course of action from an overall business perspective.

• Strong analytical skills, with the ability to define problems, collect data, establish facts, and draw valid conclusions.

• Ability to work cooperatively across all levels in a matrix environment to build and maintain positive relationships needed to achieve organizational goals.

• Demonstrated proficiency in decision-making, including the ability to negotiate and balance priorities across multiple functional departments, and make timely decisions in the face of risk and uncertainty.

• Experience in the medical device industry is highly preferred.

• Experience in the pharmaceutical, biotechnology, or healthcare sectors may also be considered.

• Familiarity with Agile and Scrum methodologies, as well as project management software such as Jira and Microsoft DevOps.

• Meticulous attention to detail.

• Ability to lead meetings with external representatives.

• Adherence to all EHS rules and requirements, including taking appropriate control measures to prevent injuries, protect the environment, and prevent pollution within the individuals span of influence and control.

• Bachelors Degree in Mechanical, Biomedical, Systems, Electrical Engineering, or a related field.

• Masters Degree or equivalent Preferred.

• PMP, Agile, and/or Scrum Certification Plus.