Job Description
To provide engineering input to ensure that changes required to released products to meet on-going business needs are conducted on time, within budget and with the required level of quality.
1. Provide design and process development support to products post launch, coordinating design and manufacturing changes and improvements to meet defined device and manufacturing requirements
2. Accept the introduction of new products and ensure their efficient ongoing transition into regular production by appropriate provision of engineering services to operations and quality
3. Evaluate and document the feasibility, reliability and risk of changes to product designs and manufacturing processes.
4. Through engineering analysis & testing demonstrate that engineering changes achieve product performance, manufacturability, safety, customer and regulatory requirements.
5. Develop timelines and cost estimates for project tasks and appraise management of performance against plan to maintain compliance to project schedule
6. Generate and review design history file documentation in compliance with GMP, QSR, ISO and company requirements throughout the project life cycle to ensure the design is fully documented
7. Assessment of NCRs and implementation of agreed corrective / preventative actions to maintain regulatory compliance
8. Work in accordance with Company Quality Standards, procedures and proce...