Product Development Manager

Our client operates in the Medical Devices business sector and the successful candidate will need to work within this regulatory framework in the Technical Department. They will be responsible for the management and the delivery of product realisation from concept to full-scale manufacture and on-going product maintenance inclusive of associated project management, enquiries and quotations processes, design & development, capital appropriation and project engineering, product support/maintenance, design transfer and new technologies.

Main responsibilities include:

• Developing & delivering NPD/NPI, tech-transfer, and product lifecycle strategies that fit the business model and enable growth.
• Deliver departmental projects on time and to budget.
• Provide leadership and development to direct reports / team.
• Provide technical support and PLM for existing products and processes.
• Collaborate with operations to deliver CAR/business case, installation, commissioning and validation of capital equipment associated with projects, on-boarding new technologies and growth.
• Ensure that risk management is integrated into all product development and product and process changes as per QMS and ISO 14971 requirements.
• Ensure that specification documentation is accurately defined, maintained and controlled as required by the QMS and other relevant standards.
• Ensure the appropriate transfer and commissioning of products from development through pilot production phase and on to full production phase.
• Adherence to QMS, HSE policies and procedures and all other company policies and procedures.

The successful candidate will have ALL of the following attributes:

• BSc or equivalent in a Chemical or Mechanical Engineering or similar.
• At least 5 years' experience in a regulated manufacturing company, such as medical devices or pharmaceutical.
• At least 3 years' experience in a management and leadership role
• Demonstrable commercial acumen and experience of successfully leading multi-functional capital projects.
• Experience of tech-transfer and design transfer requirements including product design requirements, process development, validation, change control etc
• Familiar with product design processes.
• Good working knowledge of ISO 13485 and familiarity with other medical device related standards and regulations
• Excellent skills in written and spoken English to enable communication with colleagues and to understand technical and QMS related documents.