Sector: Life Sciences
Consultant: Stewart McGrath
Salary: £40000 - £450000
Job Status: Permanent / Full Time
Position: Validation Engineer/Moulding Specialist
Salary: £40 – 45K
Responsibilities of 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 & 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
• Experience working within an ISO 13485 (medical devices) environment is beneficial.
• Desirable, Six Sigma process development
You will be working alongside the fastest growing recruitment company in the UK, who provide an unrivalled service to all of their clients and candidates across the United Kingdom. Seven currently offer the best contractor pay rates in the UK for Life Sciences, making us the best option for maximising your earning potential and career fulfilment.
What else can you expect from Seven?
– Specialist Consultant allocated to you with all the expertise you require.
– Excellent Payroll and Compliance System, ensuring that you are paid on time, every time.
– Access to Exclusive Rates, allowing you to gain earnings that no other agency can offer you.
– £250 Referral Bonus for every person you successfully refer to Seven.
If you are interested in this opportunity, please call 020 3887 7365. Please ask for Stewart McGrath in the Life Sciences team.