PURPOSE OF THE JOB:

Reporting to the R&D Director PMO for Rapid Diagnostics (Emerging Markets) the Senior R&D Program Manager will be an engineering professional, responsible for leading technical projects (e.g. new product development and sustaining engineering) through a matrix of cross functional groups. Leads and delivers significant projects as a project management expert. Responsible for the strategic alignment, development and execution of projects that contribute to the Rapid Diagnostics R&D function. Provides guidance on activities related to tactical projects, business needs and technological advances in the medical device sector. Will be responsible for project planning and management along with all activities needed for product development projects.

Develops mechanisms for monitoring project progress and for intervention and problem solving through collaboration with other technical team members. Ensures project results meet requirements regarding technical quality, reliability, schedule and cost. Solves technical and nontechnical problems throughout the life of the project. Provides timely and accurate information and status updates to project sponsors, end users and management. Participates in budget development and evaluating how project plan changes impact cost and schedule

This job description will be reviewed periodically and is subject to change by management.

MAJOR RESPONSIBILITIES

• Provides leadership and centralized management for the planning, development and execution of technical projects to achieve critical strategic business objectives. Manages multiple, often concurrent projects and consistently meets expectations.
• Competent in making difficult decisions regarding priorities among projects / programs while ensuring the buy in of teams and leaders
• Leads the project team members in using established PM tools and techniques to stay within authorized budget limits and achieve the overall project / program and organizational objectives.
• Competent in conducting risk assessments for technical and project related issues and developing mitigation plans to ensure project schedule and costs are maintained
• Innovator and forward thinker. Leads and contributes to the development of R&D organisation thru innovative thinking and application of technical knowledge.
• Develops methods, procedures and metrics for projects (scope, schedule, quality and cost) and reporting. Monitors and controls implementation plan in accordance with defined scope
• Responsible for the successful execution of significant technical projects. Through proper planning, ensures that scope, schedule, cost and customer expectations are met. Maintains a clear

EDUCATION & COMPETENCIES:

• BS in engineering or technical field with 5+ years of new product development (medical device engineering) AND 5+ years of applicable project or program management experience in medical devices, healthcare or pharma development environment
• A minimum of 10 years’ experience and a proven track record in:
• Applying project management tools to manage New Product Development Programs
• Applying project management tools to manage Sustaining Engineering Projects
• Building, managing and maintaining business partnerships across multiple functions – Clinical, RA, QA, Marketing, Commercial, Finance
• Applying knowledge of ISO standards and Design Control regulations
• Experience in leading cross functional management of CORE teams, Clinical Studies, Development Programs, Human Factors & Device Verification & Validation activities.
• Experience in development of complex sterile disposable medical devices including plastic injection molding, extrusion and assembly methods is a plus
• Experience in outsourced medical device manufacturing, manufacturing technologies and process development is a plus
• Possesses interpersonal skills to negotiate and reconcile differences, while optimizing overall business goals
• Excellent written and verbal communications skills with strong competency in MS Office tools and Project management applications.
• Certification in Process Excellence (Green Belt or Black Belt) or project management certification PMP is a plus.
• A technical / engineering background in new product development and sustaining engineering within the medical device sector.
• Fosters an environment of innovation in others, integrating experiences from multiple disciplines to develop solutions that meet the business objectives.
• Strong understanding of medical device regulations in the emerging markets, design controls, ISO13485, regulatory audits and international environmental regulations.
• Strong communication skills – in English in written and verbal; briefing, presentation, education/training skills
• Ability to successfully manage projects across various functions / businesses
• Able to influence without authority
• Ability to work in a highly matrixed and geographically diverse business environment
• Ability to create & manage a vision, think strategically, plan and organize, innovate, analyze complex data and situations, and exercise sound judgment
• Ability to communicate effectively, motivate, lead, coach, and develop employees, and collaborate with functional leaders and teams