Process Engineer

Avance Consulting; Blackpool; On-site; GBP 60,000 - 80,000; Full time

Job summary

An established industry player is seeking a skilled process engineer to enhance manufacturing processes within the MedTech sector. This role involves designing and optimizing processes, ensuring compliance with FDA and ISO standards, and collaborating with product development teams. The ideal candidate will have a strong background in manufacturing processes, expertise in Lean and Six Sigma methodologies, and a proven ability to implement effective solutions. Join a dynamic team where your contributions will drive continuous improvement and innovation in product manufacturability.

Qualifications

• Strong understanding of manufacturing processes in the MedTech industry.
• Proficiency in statistical analysis and process improvement methodologies.

Responsibilities

• Design and optimize manufacturing processes for transfer projects.
• Implement Lean and Six Sigma methodologies for continuous improvement.

Skills

Manufacturing processes in MedTech

Quality management systems

Lean methodologies

Six Sigma methodologies

Statistical analysis

Problem-solving skills

Effective communication

Process validation

Project management principles

Job description

Design, develop, and optimize manufacturing processes for transfer project.

Conduct process validations and ensure compliance with FDA and ISO regulations.

Draft and execute IQ, OQ, PQ in cleanroom environment.

Collaborate with product development teams to ensure manufacturability of new products.

Monitor and analyze process performance metrics to identify areas for improvement.

Implement Lean and Six Sigma methodologies to drive continuous improvement initiatives.

Troubleshoot process issues and work collaboratively to develop effective solutions.

Prepare technical documentation, including process flows, standard operating procedures (SOPs), and process validations.

Establish Process Monitoring and Control.

Train and support manufacturing personnel in new processes and technologies.

Participate in risk management activities related to process development and implementation.

Conduct root cause analysis and implement corrective actions for process deviations.

Your Profile

Essential skills/knowledge/experience:

1. Strong understanding of manufacturing processes in MedTech industry, including injection moulding, CNC, assembly, and sterilization.
2. Knowledge of quality management systems and regulatory requirements (e.g., FDA, ISO 13485).
3. Proficiency in statistical analysis and process improvement methodologies, such as Lean and Six Sigma.
4. Ability to interpret engineering drawings and technical specifications.
5. Excellent problem-solving skills and analytical thinking.
6. Effective communication skills with the ability to work in cross-functional teams.
7. Proven track record of successfully implementing process improvements and optimization.
8. Experience with process validation and regulatory compliance in a MedTech environment.
9. Familiarity with project management principles and experience leading cross-functional projects.