Instruments Manufacturing Engineer

About the role

This role plays a key part across the full product lifecycle of surgical instruments, from setting up new assembly lines to driving continuous improvement once production is running. You will work closely with the Production team, providing hands-on line support and troubleshooting while helping ramp up production so that every product can be built reliably and efficiently.

Key responsibilities

• Set up and continuously optimize assembly lines to increase production capacity of surgical instruments
• Lead manufacturing process development, validation, verification and equipment qualification to support production readiness
• Provide day-to-day line support and troubleshooting, and support production ramp-up
• Drive continuous improvement using data-driven problem-solving and root-cause analysis
• Identify and lead value improvement initiatives that improve quality, cost, capacity, efficiency and operational performance
• Review field complaints on medical devices and contribute to root-cause analysis and corrective actions
• Execute Change Requests and Design Transfers, and update the technical documentation of Device Master Records with R&D, CMO and suppliers
• Contribute to the risk management file and act as the voice of manufacturing during product development

Required profile

• Bachelor's degree in engineering (mechanical, industrial or equivalent)
• 2+ years of experience in manufacturing engineering, industrialization, process development or production support of high-volume complex assemblies in a highly regulated industry such as medical devices, aeronautics or automotive
• Track record of bringing complex products into production
• Fluent in English and French

Required skills

• Analytical approach to technical problems and ability to drive improvements
• Knowledge of continuous improvement methods such as Lean Manufacturing, Six Sigma or structured problem-solving
• Experience in process validation, verification, manufacturing process development and equipment qualification
• Knowledge of medical device quality standards (ISO 13485, ISO 14971, FDA 21 CFR 820) is a plus

What we offer

• A dynamic, innovative environment with cutting-edge medical technology
• A fast-growing company combining innovation and agility
• Structured onboarding and training
• High degree of autonomy and flexibility