Process Development Engineer

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

Process Development Engineer – Renfrewshire

Brightwork are partnering with an innovative medical device manufacturer to recruit a Process Development Engineer. This is an exciting opportunity to play a key role in bringing new products from development into full-scale production, ensuring robust manufacturing processes are established to support commercial growth.

Working within a highly regulated environment, you'll collaborate with multidisciplinary teams across Engineering, Quality, Operations, Supply Chain and Regulatory Affairs to drive successful product launches and continuous process improvement.

Key responsibilities include:

• 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 process FMEAs to identify and mitigate risks
• Investigating manufacturing issues, completing root cause analysis and implementing 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

Qualifications/Experience:

• HND, Degree or equivalent qualification in Engineering or a related discipline
• Experience in a Manufacturing Engineer, Process Engineer, NPI Engineer, Industrialisation Engineer or similar role
• A strong understanding of manufacturing process development and industrialisation
• Experience of process validation and equipment qualification activities
• Knowledge of risk management tools such as PFMEA/FMEA
• Experience supporting new product introduction or product transfer projects
• Exposure to Lean Manufacturing, Six Sigma or other continuous improvement methodologies
• Strong analytical and problem-solving skills
• Excellent communication and stakeholder management abilities
• A proactive and hands-on approach to engineering challenges

If you're a Process Engineer, Manufacturing Engineer, NPI Engineer, Industrialisation Engineer or Validation Engineer looking for your next challenge, we'd love to hear from you.

Brightwork Ltd offers the services of an employment agency for permanent roles and an employment business for temporary roles.

Brightwork (part of the Staffline Group), do not charge any recruitment or job-seeking fees at any stage of the hiring process.

Brightwork Ltd offers the services of an employment agency for permanent roles and an employment business for temporary roles. Brightwork (part of the Staffline Group), do not charge any recruitment or job-seeking fees at any stage of the hiring process.