Sr. Manufacturing Engineer

About the role

The Senior Manufacturing Engineer will lead the manufacturing of medical device products, driving cost, manufacturability and quality improvements. The role involves planning, designing, developing and maintaining processes across machining, packaging, welding, assembly and molding while supporting existing product lines.

Key responsibilities

• Initiate and complete technical activities for new or improved processes to meet strategic goals.
• Execute and document equipment and process validations.
• Collaborate with quality and manufacturing to integrate new products or processes.
• Maintain and approve device routers, bills of materials and manufacturing procedures.
• Monitor equipment performance, troubleshoot non‑conforming products and low yields.
• Design and implement process fixturing, gauging and ERP part numbers.
• Participate in Material Review Board, resolve non‑conformances and support cost estimation.
• Ensure compliance with ISO13485, GMP and medical device quality systems.
• Promote 5S workplace organization and contribute to Operational Excellence initiatives.

Required profile

• Bachelor’s degree in Mechanical, Industrial or related Engineering.
• Minimum 7 years of engineering experience in a manufacturing environment.
• Experience with state‑of‑the‑art manufacturing technologies and cost reduction.
• Background in medical device manufacturing and ISO13485/GMP environments.
• Lean manufacturing knowledge and ability to work in a regulated setting.

Required skills

• Machining
• Packaging
• Welding
• Assembly
• Molding
• Equipment validation
• Process validation
• ERP (part number creation)
• ISO13485 compliance
• GMP compliance
• Lean manufacturing
• 5S workplace organization