Job Title: Process Engineer
Location: Blackpool, UK (Onsite - 5 Days a Week)
Job Type: Permanent
Job Summary:
Lead process development, validation, and optimization for medical device manufacturing. Ensure regulatory compliance (FDA/ISO) and drive efficiency improvements through Lean/Six Sigma methodologies for the Network Transfer project.
Key Responsibilities:
* Design, optimize, and validate manufacturing processes for medical device production.
* Conduct process validations (IQ/OQ/PQ) in cleanroom environments.
* Collaborate with product development teams to ensure manufacturability.
* Monitor process performance metrics and implement Lean/Six Sigma improvements.
* Troubleshoot process deviations and lead root cause analysis.
* Prepare technical documentation (SOPs, process flows, validation reports).
* Train manufacturing staff on new processes and technologies.
* Ensure compliance with FDA 21 CFR, ISO 13485, and other regulatory standards.
* Lead risk management activities and implement corrective actions.
* Establish process monitoring and control systems.
Key Requirements:
Essential Skills/Experience:
* Bachelor's degree in Engineering or related field.
* 5+ years of process engineering experience in MedTech or regulated industries.
* Expertise in injection molding, CNC machining, medical assembly, and sterilization.
* Strong knowledge of FDA, ISO 13485, and EU MDR regulations.
* Proficiency in statistical analysis tools (e.g., Minitab) and Lean/Six Sigma.
* Experience leading cross-functional projects and process validation.
* Ability to interpret technical drawings and specifications.
* Proven track record of process optimization and cost reduction.
Desirable Skills:
* Certification in Six Sigma (Green/Black Belt) or Lean Manufacturing.
* Familiarity with cleanroom protocols and validation standards.