Product Engineer

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