Telephone: 087 2197421
R&D Project Manager
Our client, a medical device company in Galway is currently looking to recruit an R&D Project Manager for their site.
This role works with internal and external customers and technical resources to ensure an effective execution of the program. This includes responsibility for planning, coordinating, monitoring and directing R&D projects of small to moderate scope and complexity, including project budgets, development plans, timelines, associated documentation, or related activities associated with the development and manufacture of products, including successful transfer into the production environment.
Accountabilities & Responsibilities:
- Adheres to Company Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.
- Plan, develop, coordinate, and direct product and process development project activities from inception through successful transfer into production.
- Lead, document, and facilitate project planning and execution to completion of project tasks.
- Prepare, monitor, and ensure adherence to master project/development plans, quotes, budgets, specifications, and schedules, providing periodic status reports as required.
- Define and deliver necessary project documents in accordance with requirements and applicable domestic/international regulations or standards.
- May also evaluate, create, or modify other necessary project-related documentation, such as checklists, procedures, development information/reports, or other records required to support the company evelopment processes.
- Establish milestones and provide organization, leadership, and guidance to design/development project teams, serving as a member for those or other business teams, as assigned.
- Act as a primary contact on assigned projects.
- Receive and respond to requests for service or information, participate in status meetings (internal/external) and design reviews, and interface with departments, external customers, and suppliers, as necessary.
- Manage planning and communication with other functions (marketing, quality, regulatory, design assurance, manufacturing, etc.), as applicable, as it relates to project initiatives, policies, etc.
- Ensure projects and associated issues are effectively resolved while representing the best interests of patients, customers, and the company.
- Provide training to associates within Research & Development, cross-functional teams, or others, as required.
- Support the ongoing implementation and maintenance of an effective design control and product development system, which helps to ensure safe and effective product.
- Regular and timely attendance.
- Performs other duties as required.
Education & Experience:
- Bachelor’s degree in a technical field.
- Master's degree in business or technical field preferred.
- Certification from an accredited institution in Program Management preferred.
- Minimum of four (4) years of medical products industry experience, including four (4) years minimum in a project management capacity.
Knowledge & Skills:
- Strong interpersonal and team skills with ability to collaborate effectively and demonstrate conflict resolution.
- Proficient management and leadership skills and competencies
- Ability to manage at both a broad and tactical level.
- Effective business consulting skills including the ability to establish rapport with key internal and external business leaders to collaborate and influence.
- Working understanding of general business operations with the ability to apply concepts to establish and meet goals.
- Ability to manage key performance indicators identifying appropriate metrics and manage performance to agreed-upon service levels.
- Highly proficient verbal and written communication skills with the ability to make and deliver clear, accurate, and concise executive presentations and negotiate with customers and technical professionals.
- Solid planning and organization skills including attention to detail, multi-tasking, critical thinking and problem solving skills.
- Skilled in preparing documentation such as project plans, schedules / timelines, checklists, protocols, and reports that are often detailed and complex.
- Proficient use of a PC, office software (MS Office Suite), and specialty project software (MS Project), as required.
- Knowledge of current FDA, ISO, MDD, and other pertinent Design Control requirements.
- Comprehension of development/engineering principles, sufficient to allow participation in new product development or other projects.
- Primarily works from a sitting or standing position.
- Sitting often for extended periods of time.
- Frequent walking.
- Occasional lifting (up to 20 pounds, rarely).
- Capable of domestic and international travel.
For further information on this R&D Project Manager role in Galway please contact Anne Marie Fox on 087 2197421 / firstname.lastname@example.org
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