|Job Ref:||204727478||Employer:||cv-library.co.uk||Industry:||Civil and Structural||Job Type:||Permanent||Country:||United Kingdom||City:||Wales||Address:||Post Code:||CF3||Salary:||£34000 - £40000/annum Benefits||Post Date:||05/10/2016 03:46|
Austin Fraser are again excited to be representing a highly innovative Medical Device and healthcare organisation in South Wales. Our client, who have offices around the world, have an opportunity for a New Product Introduction Engineer at the UK Headquarters in South Wales. |
You will be highly involved in the NPI project of their eagerly awaited game changing Medical Device into full scale manufacturing. This role would suit someone that is a proactive thinker and enjoys being hands on in a fast paced environment.
As the NPI Engineer your responsibilities will include:
Roles and Responsibilities
* Drive reviews and early process development actives
* Prepare Technical Packages and assessments for product transfers.
* Assist in the setting up & documenting of sample trials & DOE's.
* Assist in compiling & reviewing Process Design Specifications, Manufacturing Plans, Risk Assessments & VMP's.
* Oversee validation testing for new products, process improvements, and cleaning validation Prepare, review, execute, and summarise validation protocols (IQ, OQ, PQ, PPQ) as required.
* Assist in validating production-related software
* Manage external equipment and tooling suppliers
* Serve as a technical resource for assessing validation requirements, solving test related problems, and developing strategies for problem prevention.
* Ensure validation efforts are conducted in an appropriate and timely manner.
* Assist in generating & reviewing equipment, process, product, manufacturing and cleaning procedures.
* Review and approval of manufacturing records (Device History Record)
* Interact with individuals from different disciplines (Manufacturing, Quality Assurance, Engineering, and Business) to plan, execute, and complete validation activities.
* Assist in generating and maintaining Equipment Files for Manufacturing Equipment
* Assist in establishing Preventative Maintenance and Calibration requirements and implementing PM / Calibration plans and procedures for manufacturing equipment.
Ideally you should have experience in and NPI environment in the Medical Device industry working to ISO 13485 and FDA 21 CFR Part 820. Pharmaceutical experience will also be considered.
If you have any further questions, please contact Ash Blanchard at Austin Fraser on NA or