Senior Manufacturing Engineer – Medical Devices

About the role

We are seeking a Senior Manufacturing Engineer to support the development and production of medical devices. The role focuses on validation, continuous improvement, and lean manufacturing activities to ensure that products, processes, and prototypes meet all required specifications.

Key responsibilities

• Validate and improve manufacturing processes, equipment, and raw materials.
• Write, review, and verify product specifications and maintain key process indicators.
• Design and build fixtures, develop testing methods, and ensure compliance with quality standards.
• Lead teams of engineers and technicians on existing processes, new product introductions, product changes, line extensions, and tooling enhancements.
• Collaborate with cross‑functional departments to resolve production issues and support equipment maintenance programs.
• Drive investigations, testing, and lean/continuous‑improvement initiatives.
• Lead prototype and pilot‑production activities, including facility planning when required.
• Manage the transfer of new products from R&D to manufacturing.
• Adhere to applicable laws, regulations, and the company’s Quality Management System while demonstrating ethics and integrity.

Required profile

• Bachelor’s degree in engineering, science, or a related field.
• Minimum of five years of experience in the medical device industry.
• Advanced proficiency in English.
• Strong knowledge of statistics and Design of Experiments (DOE); Green Belt or Black Belt certification is a plus.

Required skills

• Proficiency with MS Office (Word, Excel, PowerPoint, Outlook, Teams).
• SolidWorks and/or AutoCAD.
• Computerized Maintenance Management System (CMMS) experience.
• Statistical analysis and DOE methodology.
• Lean manufacturing principles.
• Electrical troubleshooting of process tools and equipment.