Process Development Engineer
Develop, characterise and validate manufacturing processes including injection moulding, robotics, test instrumentation, vision systems and automated assembly equipment for the production of Class II respiratory drug delivery products.
- Leadership and support of suppliers on manufacturing capacity expansion including full qualification of increased injection moulding cavitation and capacity.
- Leadership and support of suppliers on a range of assembly and test processes including manual, semi-automated and fully automated equipment as well as standard and bespoke inspection systems.
- Lead process implementation and validation projects through companies validation and verification life cycle as part of a cross functional team.
- Responsible for design, research and development and project management of new processes through the stage gated development process to achieve the required capacity, quality, and cost requirements.
- Participate in supplier selection for device manufacture, tooling and components.
- Maintain concise and accurate records of the iterative design process, trial and error and experimental steps to support the design history file and for R&D grant and tax credit submissions.
- Prepare technical documentation in clear and concise terms in accordance with good engineering practice. Be prepared to represent such documentation in an audit by customers, revenue or regulatory authority.
- Liaise closely with and communicate effectively to the R&D, manufacturing, operations, quality, sales and marketing functions through the product development life-cycle.
- Perform other assigned tasks as directed by supervisor or head of function
- 5 years' equivalent experience in a medical process development or manufacturing environment
- Minimum of a primary degree in an engineering or technological discipline
- Technical leadership and/or project management experience
- Knowledge of design verification and process validations, particularly as it pertains to equipment and manufacturing processes.
- Injection moulding process characterisation and validation experience.
- Excellent understanding of ISO 13485 and FDA design and development processes as well as GAMP methodology.
- Excellent planning, project management and coordination skills
- Ability to work as part of a multi-disciplinary team.
- Methodical and analytical approach.
- Ability to present ideas and concepts clearly and effectively to all levels of the company.
- Ability to manage risk in striving to meet objectives
- Ability to grasp and statistically analyse data to achieve desired outcomes.
- Highly motivated self-starter
- Office environment with work also performed in development labs and manufacturing areas in addition to customer/supplier facilities.
- Some travel may be required with role.
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales