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
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