Project Manager

As a high-tech specialist and world market leader, our client are synonymous with innovative medical technology. The group of companies combines core fields of expertise: research and development, production and service as well as distribution and training. Through a high level of commitment from our employees, we set the stage for continuing innovations to provide excellent products to benefit patients.
Job Purpose:

The planning, management and execution of medical device development projects
Your duties:
• Liaise with all project stakeholders and sponsors to develop comprehensive project plans so that required resources and schedules to realise project output are identified
• Execution of project in compliance with prescribed project management methodology to defined cost, quality and time
• Identify and manage project risks, issues and opportunities to ensure that the project maintains compliance to the agreed quality, cost and duration targets
• In the absence of a project Technical Authority, provide technical input, review and approval to ensure compliance with agreed specifications and all relevant regulatory standards
• Research and maintain a strong and current understanding of relevant new product development, Project Management principles, materials and manufacturing technologies and their application to medical device design
• Generate and review design history file documentation in compliance with Good Manufacturing Practice (GMP), Quality System Regulations (QSR), International Standards Organisation (ISO) and company Product Development Process (PDP) requirements
• Present clear, concise written and verbal communication to keep customers, stakeholders, senior management and project team members informed of progress, risks, issues and opportunities to ensure project deliverables are achieved
• Manage and develop a team of engineers to ensure their output is accurate and timely in line with industry standards and regulatory requirements

Education/Qualification
• A degree in an appropriate Engineering discipline or equivalent with a minimum of 5 years’ experience in a regulated and highly mechanical engineering design environment
• Project Management – preferably Prince 2 qualification

Work Experience
• Demonstrable project management competence; 3 years’ experience in an engineering or controlled environment; ideally medical device design or development.
• Ideally cGMP, ISO 13485, and FDA QSR knowledge as practiced in the disposable medical device industry

Skills
• Good analytical skills
• Ability to manage multiple projects and budgets
• Ability to effectively and efficiently plan and coordinate multiple tasks/projects.
• Ability to use initiative
• Strong problem solving skills
• Excellent verbal and written communication skills
• Ability to lead, motivate and develop team members to achieve results.
Behaviours
• Works with integrity, customer focus, accountability and teamwork.