Our client lead the way in the development of new technologies, medicines and therapies designed to make wound healing more manageable.
They are looking to recruit a Manufacturing Engineer to provide oversight and technical management of external contract manufacturing partners.
The Manufacturing Engineer will deliver engineering solutions to the business regarding external contract manufacturers. Lead and/or support engineering projects including process validation, continuous improvement, manufacturing transfer or COGS for Bought-in-Finished-Goods (BIFG).
Duties and Primary Responsibilities:
- The Manufacturing Engineer will partner with BIFG and Quality to achieve required business operational control and agreed service levels regarding Contract Manufacturers (CM).
- Deliver technical and engineering solutions to the business regarding the process at CM.
- The Manufacturing Engineer will collaborate with BIFG to support product availability from CM against build commitment & schedule.
- Plan, facilitate and execute engineering projects with CM to drive effective cost structures and control.
- The Manufacturing Engineer will provide engineering oversight of change control on technical matters, such as process validation and manufacturing transfer...
- Lead, coordinate and execute manufacturing transfer of projects on the new product development or/and design change of sustaining products.
- Actively manage the portfolio of engineering projects within CM.
- Review and approve supplier change requests and company nitiated change requests.
- Actively manage technical issues within CM using structured methodologies. Activities may include conducting device evaluations related to product / process issues and performance.
- Provide technical oversight, support and guidance to CM on process development, process validation, test method validation (TMV), risk assessment and design for manufacture (DFM).
- Partner with BIFG in initiating & driving product cost reduction and continuous improvement strategies with suppliers.
- Facilitate and drive continuous improvement with CM in terms of product quality and service.
- Exercise project management discipline on technical projects as appropriate in achieving business objectives.
- Monitor and control progress of supplier engineering projects, ensure sound application of engineering practices and provide project reviews where necessary.
- Manage company owned assets at CM sites to ensure appropriate maintenance and obsolescence planning is deployed.
- Follow strict adherence to the requirements of cGMP.
- Actively contribute to the enhancement of compliance initiatives for areas of responsibility.
- Participates in the assessment of feasibility, selection and application of proposed technology initiatives related to CM.
- Provide technical information on appropriate areas to all functions within the business.
- Communicate with stakeholders globally to ensure alignment, resolve problems, and share best practices.
- Develops presentations, status reports and measurement processes in support of the business.
- Participates in any and all reasonable work activities as may be deemed suitable and assigned by management.
- Conforms, supports, and enforces all Company policies and procedures.
- Bachelor's Degree in Biomedical, Materials Engineering, Chemical Engineering, Mechanical Engineering or relevant technical discipline.
- experience in a manufacturing or production engineering environment.
- experience in medical devices with strong preference in wound dressings.
- Demonstrated understanding of cGMP, Design Control and Validation practices.
- Demonstrated experience in manufacturing transfer and project management.
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