Project Engineer - Medical Device Manufacturing
Plans, designs, coordinates, validates, and implements high technology equipment and/or processes to support the production, finishing and inspection of the product and delivery system products. This requirement is as a result of the release of the product and forecast demand once released into the market. Must also demonstrate analytical skills in problem solving.
Major Accountabilities – as required
1. Responsible for opening Change Controls
2. Responsible for completion of all required GxP validation assessments.
3. Responsible for preparing and gaining approval for the Project plan
4. Responsible for preparing and gaining approval for the Validation Plan
5. Responsible for coordination and completion of Risk Management documents and generation of all validation protocols.
6. Execute pre-validation studies as required
7. Manage and execute the equipment and process validations
8. Coordinate all necessary associate training and release the necessary production SOPs and associated documentation.
9. Generate all required validation reports
10. Change Control Closure
Specific Position Knowledge/Skills/Abilities
1. Knowledge and experience of process engineering, equipment and automation specification
2. Knowledge of GMP validation and change control requirements.
3. Knowledge of regulatory requirements of bodies such as FDA/CE/TUV
4. Knowledge of data analysis by statistical methods.
5. Well-developed Project Management skills
6. PC and software proficiency - Microsoft software and Microsoft project
7. Report writing expertise and highly developed people skills. Knowledge of process analysis and optimisation, and basic industrial engineering.
8. Must also demonstrate analytical skills in problem solving.
9. Attention to detail with excellent organizational skills
10.Knowledge of requirements of machinery directive – i.e. CE marking
Minimum: 3-5 years’ experience in high volume manufacturing environment with experience of process engineering and process/product introduction.
Preferred: 5-10 years’ experience in medical device manufacturing executing product and process technology transfers in a regulated industry environment. Experience to include cross site projects and R&D Liaison. Project management and team leadership experience. Regulated industry experience.