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
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.
Benefits
What we offer:
- A dynamic, innovative environment with cutting-edge medical technology that is shaping the future of robotic surgery.
- Fast-growing Company where innovation meets agility.
- Structured onboarding program and training, ensuring a confident start.
- High degree of autonomy and flexibility.
Skills Required
- Bachelor's degree in engineering, preferably mechanical, industrial, or equivalent
- 2+ years of experience in manufacturing engineering, industrialization, process development, or production support for high-volume complex assemblies in a highly regulated industry
- Ability to analyze technical problems, propose solutions, and drive manufacturing improvements
- Knowledge of continuous improvement methodologies such as Lean Manufacturing, Six Sigma, or structured problem-solving
- Experience leading process validation, verification, or manufacturing process development activities
- Experience with manufacturing equipment qualification
- Track record of bringing complex products into production
- Knowledge of medical device quality standards and regulations, including ISO 13485, ISO 14971, and FDA 21 CFR 820
- Fluency in English and French
What We Do
At Distalmotion, we aim to deliver the benefits of robotic surgery to more surgeons, more hospitals, and more patients globally. Our vision is to establish a new standard of care, removing traditional barriers and complexities of robotics to ensure greater access to best-in-class minimally invasive surgery. Its surgical robot Dexter® is designed to deliver the benefits of robotics to more hospitals by being simple and straightforward to use, and more accessible as a modular, small format, and open system. As an open system, Dexter is designed to work natively with third party 3D imaging systems, energy devices, vessel sealers and other laparoscopic devices. It has a suite of fully wristed single use instruments providing the user with dexterity, precision of movement, reliable instrument performance, and lower reprocessing requirements.
