Director, PMO

Description

• You will oversee a portfolio of complex engineering and regulatory-driven medical device projects and ensure that projects are completed on time, within scope, and meet regulatory and quality standards.
• You will directly manage key corporate initiatives that align with strategic business goals.
• You will manage the complexities of the medical device industry while fostering cross-functional collaboration and operational efficiency. 
• You will foster a culture of collaboration, accountability, and excellence.

• Lead the PMO function and develop a strategic roadmap to ensure best-in-class project management practices are integrated into the company’s product development process.
• Direct PMO team to ensure successful project execution in alignment with client requirements, industry standards, and regulatory guidelines.
• Develop and continuously improve standardized project management methodologies, ensuring alignment with regulatory requirements (FDA, CE marking, ISO 13485, etc.) and best practices.
• Establish and improve PMO processes, provide strategic leadership, and ensure projects are delivered on time, within scope, and budget while maintaining high levels of transparency, quality, and regulatory compliance.
• For your specific functional area, you must deliver effective ownership and execution of Velentium’s customer promise- 100% on-time, 100% on-spec, 100% of the time, leveraging your functional resources to execute program deliverables at, or better than quoted cost, quality, and timeliness
• Provide visionary leadership to a team of project and program managers, guiding them in delivering complex medical device development projects on time and within budget while adhering to high-quality standards.
• Collaborate with executive leadership to ensure PMO objectives align with overall business goals and regulatory requirements.
• Ensure the successful delivery of projects within the context of rigorous regulatory guidelines, quality standards, and risk management processes.
• Define and monitor key project milestones, deliverables, and timelines, providing regular updates to executive leadership on project status, risks, and mitigation strategies.
• Identify, assess, and mitigate risks related to both technical and regulatory aspects of medical device development.
• Establish and manage robust change management processes to address scope changes, evolving regulatory requirements, and customer needs.
• Implement risk management best practices to ensure product safety and quality standards.
• Collaborate with finance teams to manage project budgets, forecasts, and cost tracking to ensure financial objectives are met.
• Provide transparency to stakeholders regarding project costs, financial and technological risks, and resource allocation.
• Analyze and report on project performance, including financial metrics and variance analysis, to inform executive leadership of potential issues.
• Serve as the primary point of contact for executive leadership, internal and external stakeholders, ensuring clear, consistent, and transparent communication on project status, project goals, risks, and outcomes.
• Foster strong relationships with cross-functional teams, including R&D, QA/RA, and manufacturing operations, ensuring alignment on project objectives and timelines.
• Drive continuous process improvements within the PMO, increase efficiency and effectiveness.
• Leverage lessons learned to enhance project delivery capabilities and mitigate repeated issues. 
• Build and develop a high-performing PMO team through coaching, mentoring, and professional development opportunities.
• Promote the use and standardization of project management tools and techniques to improve project tracking, reporting, and team collaboration.

Requirements

Basic Qualifications: 

• Bachelor's degree in Engineering, Biomedical Engineering, or a related field or equivalent experience is required 
• 10 years of relevant experience, with at least 5 years of managerial experience, preferably within the medical device or life      sciences industry. 
• Financial acumen with experience managing budgets, optimizing workforce/working capital.
• Exceptional communication, negotiation and relationship building skills.
• Strong analytical skills and ability to use data to drive decision making.

Additional Qualifications: 

• Advanced degree preferred
• PMP (Project Management Professional) or similar project management certification, desirable.
• Proven experience leading complex, multi-disciplinary teams in the successful development and commercialization of medical devices.
• Abreast of industry trends and new project management tools to implement best practices and improve PMO performance.
• Excellent leadership, communication, and stakeholder management skills.· Ability to manage multiple priorities and complex projects in a fast-paced, regulated environment.
• Strong analytical and problem-solving skills, able to proactively detect and resolve issues.
• Proficiency in project management software and tools (e.g., MS Project, JIRA, or similar).
• Solutions oriented attitude to resolve challenging engineering problems
• A fit with Velentium culture: Honor, Results , Humble Charisma, Velocity, Ingenuity
• Demonstrated experience that displays an ability to learn and apply new skills
• A demonstrated ability to work alone and in teams
• A desire to thrive in a rapidly changing and quick paced environment