Product Development Engineer

Personnel Futures Ltd
Cardiff (Caerdydd)
11 Sep 2018
18 Sep 2018
Contract Type
Full Time

As Product Development Engineer you will work as part of a project team to conceive, design and develop medical devices through initial concept design, engineering analysis, prototyping, risk assessment and evaluation to realise the handheld electrosurgical instrument portfolio. Your duties will include:

·Design, develop and prototype new products in accordance with company Product Development Process (PDP) requirements to meet functional, clinical, customer and manufacturing requirements

·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 through engineering testing and analysis in order to demonstrate 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 Good Manufacturing Practice (GMP), Quality System Regulations (QSR), International Standards Organisation (ISO) and company PDP requirements throughout the project life cycle to ensure the design is fully documented.

·Coordinate vendor activities relative to communication of specifications, development schedules and progression tracking in order to obtain components, supplies or equipment to support prototype or product procurement and assembly

·Deliver manufacturable designs acceptable to operations by applying Design for Manufacture (DFM) and Design for Assembly (DFA) principles and feedback from manufacturing engineers, external suppliers and other sources

Your qualifications

·Bachelor’s degree in an appropriate Engineering discipline or equivalent experience in a regulated and highly mechanical engineering design environment

·Ideally medical device design or development experience

·Understanding of a wide range of engineering technologies used in design and manufacturing

·Knowledge of mechanical design relating particularly to mechanisms

·Excellent knowledge of and ability to critique 2D engineering drawings and 3D modelling

·Ideally cGMP, ISO 13485, and FDA QSR knowledge as practiced in the disposable medical device industry

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