Product Development Engineer

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. Our Cardiff facility now requires a

Job Purpose:
To conceive, design and develop medical devices through initial concept design, engineering analysis, prototyping, risk assessment and evaluation.
Your duties:
• Design, develop and prototype new products in accordance with company Product Development Process (PDP) requirements to meet functional, clinical, customer and manufacturing requirements
• Production of 3D Computer Aided Design (CAD) & data to realise the conceptual design as a finished product for transfer to production
• The translation of concepts into virtual or physical prototypes to allow evaluation and/or testing
• Creation of formal bill of materials and release through Product Lifecycle Management (PLM) system
• Maintain a strong and current understanding of relevant new product development and manufacturing technologies and their application to medical device design to meet or exceed customer, company and project needs
• Evaluate and document the feasibility, reliability and risk of concepts and/or prototypes ensuring that the product performance, manufacturability, safety and cost are consistent with the customer, regulatory and production requirements
• Develop timelines and cost estimate for development tasks and appraise management of performance against plan to maintain compliance to project schedule
• Generate and review design history file documentation in compliance with required regulations and company PDP requirements
• Coordinate vendor activities in order to support prototype or product procurement and assembly
• The delivery of manufacturable designs acceptable to operations by applying Design for Manufacture (DFM) and Design for Assembly (DFA) principles

Education/Qualification
• Degree in an appropriate Engineering discipline or equivalent, with a minimum of 2 years’ experience in a regulated and highly mechanical engineering design environment
• Or HND or equivalent qualification if supported by a minimum of 5 years design office experience

Work Experience
• At least two years’ professional engineering experience, preferably in a highly regulated medical device design/development environment.
• Strong working knowledge of SolidWorks 3D CAD system, a formal qualification would be preferably.

Skills
• Understanding of a wide range of engineering technologies used in design and manufacturing
• Knowledge of mechanical design relating particularly to mechanisms
• The ability to critique 2D engineering drawings and 3D modelling
• Experience of BS8888 and its related standards
• Capable of producing accurate & concise detailed drawings as needed for global component procurement
• Ideally cGMP, ISO 13485, and FDA QSR knowledge as practiced in the disposable medical device industry
• Strong analytical, and mathematical skills
• Good planning, organisation and control skills
• Excellent verbal and written communication skills
• Competent in MS Word, Powerpoint and Excel