Staff Engineer, Advance Operations

What You Will Do

• Design and develop new products, components, and systems based on defined functional requirements.
• Create and maintain engineering drawings, models, specifications, and bills of materials using CAD/CAE tools.
• Plan, execute, and evaluate design verification, validation, and fitness-for-use testing activities.
• Develop and implement process formulations, methods, controls, and validation plans to meet quality requirements.
• Analyze design performance, reliability, safety, manufacturability, and cost considerations throughout development.
• Collaborate with manufacturing teams, suppliers, contract manufacturers, and technical specialists to optimize product and process designs.
• Review product development requirements and assess compatibility with manufacturing methods, schedules, and cost targets.
• Recommend, document, and implement engineering improvements, process modifications, and technical solutions based on data analysis.

What You Will Need

Required:

• Bachelor’s degree in Engineering or a related technical field and fluent English
• Minimum 4 years of engineering experience in product development, design engineering, process engineering, or a related discipline.
• Experience with product design, testing, validation, and technical documentation.
• Experience using CAD or CAE software for modeling, design, or engineering analysis.

Preferred:

• Experience in a regulated industry such as medical devices, pharmaceuticals, aerospace, automotive, or healthcare manufacturing are highly desirable.
• Experience developing and executing process validation plans.
• Experience working with manufacturing partners, suppliers, or contract manufacturers.
• Knowledge of quality systems, design controls, and engineering change management processes.