Process Development Engineer: NPI & Scale-Up

Brightwork Limited; Erskine; On-site; GBP 43,000 - 63,000; Full time

Job summary

Brightwork Ltd, partnering with an innovative medical device manufacturer in Renfrewshire, is hiring a Process Development Engineer. The role focuses on moving products from development to full-scale production, ensuring robust manufacturing processes for growth.

You will work in a regulated environment with cross-functional teams spanning Engineering, Quality, Operations, Supply Chain and Regulatory Affairs to drive launches and continuous improvement.

Qualifications

• HND, Degree or equivalent qualification in Engineering or related discipline.
• Experience in Manufacturing Engineer, Process Engineer, NPI Engineer, Industrialisation Engineer or similar role.
• Strong understanding of manufacturing process development and industrialisation.
• Experience with process validation and equipment qualification.
• Knowledge of PFMEA/FMEA risk management tools.
• Experience supporting NPI or product transfer projects.
• Exposure to Lean Manufacturing, Six Sigma or other CI methodologies.
• Strong analytical and problem-solving skills.
• Excellent communication and stakeholder management abilities.
• Hands-on proactive engineering approach.

Responsibilities

• Supporting new product introduction (NPI) and design transfer activities
• Developing, optimising and implementing manufacturing processes
• Creating and maintaining manufacturing documentation, work instructions and process specifications
• Leading process validation activities including IQ, OQ and PQ where required
• Supporting equipment qualification and manufacturing readiness
• Conducting risk assessments and PFMEA/FMEA to identify and mitigate risks
• Investigating manufacturing issues, root cause analysis and corrective actions
• Supporting pilot builds, process scale-up and continuous improvement projects
• Working closely with suppliers and internal stakeholders to ensure successful product launch and transfer activities
• Maintaining compliance with quality and regulatory requirements

Skills

NPI

Process development

Industrialisation

Process validation

Equipment qualification

PFMEA/FMEA

Risk management

Lean/Six Sigma

Root cause analysis

Stakeholder management

Education

Engineering degree

Job description

Brightwork Ltd, partnering with an innovative medical device manufacturer in Renfrewshire, is hiring a Process Development Engineer. The role focuses on moving products from development to full-scale production, ensuring robust manufacturing processes for growth.

You will work in a regulated environment with cross-functional teams spanning Engineering, Quality, Operations, Supply Chain and Regulatory Affairs to drive launches and continuous improvement.