Product Engineer

First Base; Stonehouse; On-site; GBP 80,000 - 100,000; Full time

Job summary

A reputable manufacturing organization in Stonehouse is seeking a Product Engineer to join its Product Development team. This role focuses on re-engineering and re-qualifying single-use laboratory consumables within the biopharmaceutical sector. The ideal candidate should have experience with injection moulded components and possess strong mechanical engineering qualifications. You will coordinate product requalification activities and collaborate closely across engineering, quality, and operations teams. This is a full-time position requiring onsite presence.

Qualifications

• Qualified in Mechanical Engineering or a related discipline.
• Experienced with injection moulded plastic components.
• Proficient in creating FMEAs and qualification documentation.

Responsibilities

• Coordinate product engineering activities for requalification.
• Conduct root cause analysis and create FMEAs.
• Define qualification protocols and criteria for testing.

Skills

Mechanical Engineering qualification

Experience with injection moulded plastic components

FMEAs and risk assessments

Knowledge of validation processes

CAD experience, ideally using Creo

Strong communication skills

Proactive and organized

Education

Qualification in Mechanical Engineering or related discipline

Tools

Creo

Job description

Product Engineer - Product Development

Location: Stonehouse, Gloucestershire (onsite)

Hours: Full-time - 18-month FTC

Salary: Competitive, dependent on experience

Overview

An established manufacturing organisation is seeking a Product Engineer to join its Product Development team based in Stonehouse. This role will focus on the re‑engineering and re‑qualification of single-use laboratory consumables used within the biopharmaceutical industry. You will work closely with Product Development, Quality, Operations and Product Management teams to support validation, qualification and continuous improvement activities.

Key Responsibilities

• Coordinate product engineering activities relating to the requalification of injection moulded plastic devices
• Carry out root cause analysis and create FMEAs for injection moulded components
• Define product qualification protocols and acceptance criteria for functional testing
• Coordinate and execute validation test protocols with internal stakeholders
• Work closely with Operations and the tool shop to support qualification activities for replacement injection moulds, including IQ, OQ and PQ
• Establish quality control processes, measurement instructions and testing documentation
• Support and contribute to Engineering Change Requests
• Arrange and report on testing activities, including pull and push force testing to determine tolerances
• Update and maintain CAD models and associated documentation

Key Skills and Experience

• Qualification in Mechanical Engineering or a related discipline preferred
• Experience with injection moulded plastic components, ideally within disposable or single-use products
• Experience creating FMEAs, risk assessments and qualification documentation
• Working knowledge of validation and qualification processes
• CAD experience, ideally using Creo
• Strong communication skills and the ability to work effectively with cross-functional teams
• Proactive, organised and able to manage multiple tasks
• Able to work independently while collaborating with wider engineering, quality and operations teams

Additional Information

This role is based onsite due to business requirements and involves close collaboration with UK and European stakeholders.