Project Manager in London

Planning, management and execution of medical device development projects to realise the devices appropriate to the Business Unit portfolio.

Responsibilities

• 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 in order to realise product development objectives.
• 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 the technical input, review and approval for all project output 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 to meet or exceed customer, company and project needs.
• 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 throughout the project life cycle to ensure the design is fully documented.
• 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.
• Work in accordance with Company Quality Standards, procedures and processes and comply with the requirements of Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP). Adhere to the standards of behaviours, policies and procedures as laid out in the employee handbook.
• All other essential related duties as required.

Scope of the Job

• Supervision Of Up To Three Roles Including:

• Senior Product Development Engineers
• Product Development Engineers
• Process Development Engineers

Education / Qualifications

• Bachelor’s degree in an appropriate Engineering discipline or equivalent with a minimum of 5 years' experience in a regulated and highly mechanical engineering design environment with Project Management experience.

Behaviours / Skills / Experience

• Ideally medical device design or development experience.
• 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.
• Ideally cGMP, ISO 13485, & FDA QSR knowledge as practiced in the disposable medical device industry.
• Competent in MS Word, PowerPoint, Excel and Project.

Benefits

• Bonus – up to 10% (of annual salary) bonus – dependant on achievement of financial measures (terms and conditions apply).
• Pension – Company puts 10% of salary into pension; there is no obligation for employee to contribute but can do under salary sacrifice.
• Holidays – Currently 25 days holiday plus 8.