Director of Project Management Organization

Director of Project Management Organization

Ensera Design is a world-class user-centred innovation and product development consultancy, specializing in the medical and consumer health sectors with offices in Bristol, Colorado and New Jersey. As part of Ensera, we collaborate globally with contract manufacturing facilities in Europe, the USA, and Asia.

The Opportunity

We are seeking an experienced and driven Director of Project Management Organization to lead our North American project management function. This is a pivotal leadership role, responsible for ensuring the successful delivery of all projects, aligning outcomes with Ensera Design’s strategic goals, and building a high-performing project management team.

You will shape and continuously improve our project management processes, mentor and develop project managers, and act as Project Manager and Proposal Manager for key projects. You’ll also play a key role in resource management, business development, and client engagement.

This role is primarily full-time onsite, though for the right candidate we may consider a hybrid arrangement with a minimum of three days per week in the office.

What You’ll Do

• Lead, mentor, and develop a team of project managers, fostering a collaborative and high-performance environment
• Develop and implement project management strategies, methodologies, and best practices
• Oversee the planning, execution, and delivery of all projects, ensuring they are completed on time, within budget, and to the highest quality standards
• Act as Project Manager for multidisciplinary and key projects, ensuring successful outcomes
• Support business development by identifying new opportunities, participating in client meetings, and generating project development plans
• Allocate resources efficiently across projects and provide regular utilization reports
• Build and maintain strong relationships with clients and stakeholders, serving as a point of escalation for project concerns
• Ensure all project work is compliant with quality management systems (ISO 13485, ISO 14971) and regulatory requirements (e.g., FDA)
• Implement and oversee quality control processes, conduct project reviews, and drive continuous improvement
• Maintain accurate project documentation and provide regular status updates to stakeholders and executive management
• Travel (less than 20%) to visit clients as needed

Your Skills and Experience

• Bachelor’s degree in Project Management, Business Administration, Engineering, or a related field (Masters preferred)
• Minimum 10 years’ experience in project management, with at least 5 years in a leadership role
• Proven experience managing complex projects and leading project management teams, ideally in a consultancy or medical device environment
• Strong management methodologies (e.g., PRINCE2, APM, Agile), tools, and best practices
• Excellent leadership, communication, and interpersonal skills
• Experience in a client-facing role and business development support
• Proficiency in project management software (e.g., MS Project, Asana, Trello)
• Working knowledge of device design and development in the medical field
• PMP or similar certification is a plus
• Experience with ISO 13485 quality management systems
• Strong organizational, time management, and financial reporting skills
• Ability to work under pressure and manage multiple projects simultaneously
• Strategic thinker with a passion for process improvement and team building

Culture

At Ensera Design, we specialize in medical device design and innovation, delivering solutions that improve patient outcomes. We are a mission-driven team with a vision to be the partner of choice for healthcare pioneers seeking fresh thinking and innovative end-to-end solutions delivered at pace.

Our mission is to enable healthcare to move forward with fast, flexible, and responsive design and manufacturing services that simplify complex challenges for pharmaceutical and medical device clients.

We value creativity, collaboration, and accountability, with a strong emphasis on engineering rigor and attention to detail. As part of our team, you will be encouraged to pursue innovation, continuous improvement, and professional growth, while contributing to…