Key Responsibilities
- New equipment specification, sourcing and validation
- Process / product validation
- Concept drawings
- Technical drawing
- Process fault finding and support
- Manufacturing Process Record creation
- Work instruction generation and training
- Technical support
- Technical report generation
- Project management
- Training
- Preparation of auditable records of all activities, such as protocols, lab book records, manufacturing paperwork (R&D and Production), Design History Files
Essential skills:
- Excellent communication skills
- Ability to work effectively with all global cultures
- Pursue expert knowledge of Healthcare regulatory systems
- A passion for continual earning of technical and creative skills
- Commercial awareness
- Relevant IT skills, including CAD
- A high degree of technical knowledge balanced and a hands-on approach
- Programme and project coordination
Essential experience:
- Must have experience in the medical device field with process development, test methods development, protocol and report writing, design verification and experience presenting technical concepts.
- Must have demonstrated capabilities in developing, writing, and executing design validation protocols and reports.
- Demonstrated application of statistical methodologies.
- Experience in Medical Devices and working within FDA/ISO Quality System Requirements.
- Would consider different Engineering disciplines (mechanical, chemical, biomedical) for the position.
Essential qualifications:
Technical/Scientific Degree level qualification in life science subject, or other related fields
#ARCHERSJOBS