Sector: Life Sciences
Consultant: Harvey Havell
Salary: £40000 - £45000
Job Status: Permanent / Full Time
JOB TITLE: Validation Engineer / Moulding Specialist
SALARY: £45k+ depending on experience
LOCATION: Outskirts of Cheltenham
REPORTING TO: Engineering Manager
KEY PURPOSE OF ROLE:
- Responsible for completing validation & technical activities in support of routine manufacturing production, introduction of new products into manufacture and development of the existing products & processes. Particular focus on working with injection moulded components to support existing products and NPI.
RESPONSIBILITIES OF THE ROLE:
- Reporting to the Engineering Manager, taking a lead role in industrialization phase of New Product Introduction projects.
- Responsible for providing DFM/DFA guidance to Design department.
- Point of contact for suppliers to ensure products and processes supplied to the company are specified and manufactured correctly.
- Responsible for ensuring all products, equipment and processes either supplied to the company, or conducted on site, are adequately verified/validated.
- Able to take ownership of existing mould tooling, supporting suppliers on maintenance and repair schedules. Identifying opportunities to reduce breakdowns and improve utilization.
- Provide subject matter expertise for Process Validation of Injection mouldings and associated assembly methods.
- Able to generate all required documentation to complete a Process Validation in accordance with current Medical Device regulations.
- Prepare detailed project plans using MS Project to include all tasks required to deliver the NPI phase of NPD.
- Using metrology skills (inc CMM/VMM) and statistical data analysis (using Minitab) to support both process validation and routine manufacturing investigations.
- Ensuring NPI documentation is correctly reported and filed into Design History Files, Device Master Records and Summary Technical Documentation (STED) as appropriate.
- Able to deputise for the Engineering Manager when required.
- Manage revalidation, process FMEA and other Engineering duties in line with the change process.
- Assist with production problem solving or subsequent resolution.
QUALIFICATIONS AND EXPERIENCE:
- 5 years of experience in an engineering role within a regulated environment.
- Experience and exposure to plastics processing and tooling.
- Desirable to be experienced in shop floor moulding problem solving with 3rd parties using tools such as 8D
- Experience with process development and validation.
- A time served engineer or degree qualified within a relevant technical discipline.
- Excellent communication and interpersonal skills.
- Experience working within an ISO 13485 (medical devices) environment is beneficial.
- Desirable, Six Sigma process development
For more information, please get in touch with Harvey @ Seven Life Sciences