Description
- Ensure all product development projects follow the design control process according to company enquiry and design control procedure and in line with ISO13485.
- Through regular dip auditing ensure all physical and electronic project documentation is correctly maintained.
- Maintaining the company drawing & CAD issue and control system.
- Facilitate the design risk assessment process (dFMEA) according to company risk management procedures (ISO 14971).
- Ensure all project sample registers are kept up to date.
- Support other departments with all design requirements including but not limited to; Concept Designs, Drawings and technical documentation.
- Maintain project control documents so that progress versus agreed targets, timescale and cost is clear.
- Ensure project scope is defined and maintained through the life of the project.
- Provide regular project reporting to management and customers as required.
- Provide technical support as required for existing products
- Minimum 3 years' experience within industry-sector.
- Bachelor's degree or equivalent in an Engineering or Science discipline.
- Experience in project management.
- Experience with creation of 3D CAD and 2D Engineering drawings (Solidworks or similar).
- Experience of Design for Manufacture.
- Knowledge of Standards Applicable to Medical Devices, covering but not limited to;
- Product Design & Development
- Safety & Risk Management
- Sterilisation of medical devices
- Experience of managing a risk management process for medical devices (dFMEA)
- Experienced in the practical application of Mechanical Engineering principles
- Awareness of plastics and metals for use in medical devices and tooling.
- Effective oral and written communication skills in English
Rate £33-35 hr
6 months