Manufacturing Engineer (New Product Transfer)

About the role

The Manufacturing Engineer will lead the transfer of new medical‑device products into a robust, efficient production environment. Reporting to the Group Engineering Lead, you will work with cross‑functional teams to ensure processes, equipment, documentation and controls meet ISO13485, GMP and safety standards.

Key responsibilities

• Execute assigned project tasks and lead work packages to successful completion.
• Implement process controls to achieve repeatable, commercial‑scale manufacturing.
• Drive continuous‑improvement initiatives using Six Sigma and statistical tools.
• Apply scientific problem‑solving methods to optimise efficiency.
• Ensure all engineering work complies with GMP, QA/Regulatory and EHS standards.
• Collaborate with Automation Engineering to develop stable, capable new processes.
• Provide technical support for new product/technology introductions and manage changes.
• Evaluate and correct non‑conforming products and processes.
• Complete equipment and process validations (IQ, OQ, PQ) and risk assessments.
• Develop in‑house subject‑matter experts across core technologies.

Required profile

• Honours (Level 8) degree in Engineering or a related discipline.
• 3–5 years of manufacturing engineering experience in the medical‑device/health‑care sector.
• Experience with thrombectomy/atherectomy devices or laser metal welding is a plus.
• Proven track record of implementing continuous‑improvement projects.
• Familiarity with scale‑up of manufacturing processes and validation methodologies.

Required skills

• Proficiency with CAD software.
• Statistical analysis tools and Six Sigma methodology.
• Validation techniques (IQ, OQ, PQ).
• Knowledge of ISO13485, GMP and regulatory quality standards.
• Laser welding of metals (experience preferred).
• Process control and risk assessment expertise.