Instruments Manufacturing Engineer

As an Instruments Manufacturing Engineer, you will play a key role across the full product lifecycle of surgical instruments, from setting up new assembly lines to driving continuous improvement once production is up and running. You will make sure every product can be built reliably and efficiently and meet yield and performance as volumes grow. Working closely with the Production team, you will provide hands-on line support and troubleshooting and help ramp up production.

Duties & Responsibilities :

· Set up and continuously optimize assembly lines to increase production capacity of surgical instruments.

· Lead manufacturing process development, validation, verification and equipment qualification activities to support production readiness and process sustainability.

· Provide day-to-day line support troubleshooting to keep production running and support production ramp-up.

· Drive continuous improvement of production, using data-driven problem-solving and root-cause analysis to identify issues and improve processes and design.

· Identify and lead value improvement initiatives that enhance quality, cost, capacity, efficiency and operational performance.

· Review field complaints related to medical devices, and contribute to root-cause analysis and corrective actions.Initiate, assess impacts on technical and quality aspects, and execute Change Requests, and associated Design Transfers to production.

· Update the technical documentation of the Device Master Records (DMR) in coordination with R&D, CMO and/or suppliers.

· Participate in the creation and the continuous update of the risk management file in coordination with R&D, CMO and/or suppliers.

· Be the voice of manufacturing during product development to ensure products can be manufactured reliably and efficiently.

Requirements :

· 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 within a highly regulated industry (e.g. medical device, aeronautical, automotive).

· Demonstrated ability to analyse technical problems, propose solutions and drive improvements in a manufacturing environment.

· Knowledge of continuous improvement methodologies, including Lean Manufacturing, Six Sigma, or structured problem-solving approaches.

· Experience in leading process validation, verification, or manufacturing process development activities.

· Experience in manufacturing equipment qualification.

· A track record of successfully bringing complex products into production.

· Knowledge of medical device quality standards and regulations (ISO 13485, ISO 14971, FDA 21 CFR 820) is a plus.

· Fluent in English and French.