Manufacturing Engineer

The Manufacturing Engineer in a sustaining role focuses on maintaining and improving existing manufacturing processes to ensure consistent production of high-quality medical devices. This role is integral to troubleshooting issues, implementing process improvements, and supporting ongoing production activities while maintaining compliance with regulatory and quality standards.

This includes advanced manufacturing processes such as, laser processing – cutting/welding, ultrasonic processing, coating processes, metal chemical processes and heat treatment, moulding/extrusion and component assembly.

Job Requirements

Process Support & Troubleshooting:

• • Provide day-to-day technical support to resolve production challenges, minimize downtime, and ensure stable operations.
  • Analyse root causes of production issues and implement corrective actions to address defects or inefficiencies.

Continuous Improvement:

• • Identify and implement opportunities to improve yields, reduce waste, and enhance overall production efficiency.
  • Utilize Lean Manufacturing, Six Sigma, and other methodologies to drive process enhancements.

Change Management:

• • Lead or support engineering changes (ECOs) to existing products, processes, or equipment.
  • Validate and document changes to ensure they meet quality, compliance, and operational requirements.

Equipment & Tooling Maintenance:

• • Ensure the continued functionality of production equipment through preventative maintenance programs.
  • Support equipment upgrades or replacements to improve reliability and performance.

Collaboration with Cross-functional Teams:

• • Partner with Quality, Operations, NPD and Supply Chain teams to address process deviations, non-conformances, and supplier issues.

Documentation & Reporting:

• • Maintain accurate process documentation, including SOPs, work instructions, validation protocols, and technical reports.
  • Track and report key performance metrics, such as yields, downtime, and defect rates.

Health & Safety

• • • Ensure that all Health, Safety and Environmental requirements are fulfilled.

What your background should look like

Qualifications & Key Requirements

• Engineering level 8 degree, or equivalent qualification.
• Preferably a minimum of 3 years’ experience in a similar roles
• Strong problem-solving and troubleshooting skills.
• Ability to prioritize tasks and manage multiple ongoing projects.
• Excellent communication and collaboration skills to work with cross-functional teams.
• Catheter assembly experience a definite advantage including braided/coiled shaft assembly and reflow, tip bonding and handle assembly.
• Must be able to plan, organize, and implement multiple concurrent tasks and projects.
• Jigs & Fixtures design and maintenance experience would be an advantage.
• Demonstrate a practical understanding of lean manufacturing principles and statistics.
• Equipment and Process Validation experience with working knowledge of Minitab software.
• SolidWorks /AutoCAD skills would be an advantage.
• Knowledge of ISO & FDA compliance.
• Demonstrate a dynamic, motivated & flexible approach to work with results oriented attitude

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