Title: Manufacturing Engineer
The responsibilities of The Manufacturing Engineer include performing various support and technical roles to the production/manufacturing department.
- Manage production processes to ensure that targets, capacity and productivity are achieved.
- Previous experience in Manufacturing processes and Product Transfers set up and scale up.
- Apply "Lean" principles to production lines.
- Specification, Procurement, Installation, and Validation of Manufacturing Equipment. This includes on site Factory Acceptance Testing of equipment.
- Set up Calibration and Preventive Maintenance routines.
- Provide continuous day to day support to Production, seeking ongoing improvement in operation performance while also maintaining highest levels of regulatory conformance. Trouble shoot production related issues, executing "robust permanent fix" solutions.
- Ability to establish and maintain all Manufacturing documentation including the following; Equipment documentation, pFMEAs, TMVs, Bills of Materials, Part Numbers, Product routine's, Work Instructions, Manufacturing procedures and Logs.
- Order and set up Components, Consumables and Material Product, Components, Consumables which are necessary for validation and production.
- Link with R&D and Quality Operations to ensure that the processes are all timely and cost effective.
- Draft IQ/OQ/PQ protocols. Develop and implement required validations which comply with regulatory requirements to include Equipment, Process & Product validations.
- Proven technical expertise and competence across all aspects of manufacturing engineering function including lean.
- Demonstrated expertise and knowledge of the medical device industry.
- Has previously conducted IQ/OQ/PQs and/or validations in a regulated environment.
- Detailed knowledge of the regulatory environment in which the business operates.
- Proven written and oral communication skills and an ability to prepare competent business cases while also being a team player.
- An analytical approach to problem solving.
- Good oral communication skills with the capacity to represent the company to customer and representatives of regulatory bodies.
- Is creative, constantly learning and exploring new ideas.
- High level of flexibility required concerning role and prioritisation of projects and activities.
- Ability to maintain the highest levels of confidentiality both internally and externally.
- Engineering Degree or equivalent.
- Minimum of 3 years' engineering experience, working in a similar role. Catheter manufacturing knowledge is highly desirable.
- High level of technical understanding of set up and maintenance of manufacturing processes. Experience in equipment design, validation and Lean Manufacturing highly desirable.
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As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.