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Instruments Manufacturing Engineer

Distalmotion SA · Épalinges

Nouveau
Mid 🇬🇧 English
Lean Manufacturing Six Sigma Process validation Equipment qualification ISO 13485 ISO 14971 FDA 21 CFR 820

Description du poste

About the role

As an Instruments Manufacturing Engineer at Distalmotion, 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 running. You will work closely with the Production team, providing hands-on line support and troubleshooting while helping ramp up production.

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 and process sustainability.
  • 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.
  • 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.
  • Initiate, assess and execute Change Requests and associated Design Transfers, and update the technical documentation of Device Master Records with R&D, CMO and/or 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

  • Knowledge of continuous improvement methodologies such as Lean Manufacturing, Six Sigma or structured problem-solving approaches.
  • Experience leading process validation, verification and manufacturing process development, and manufacturing equipment qualification.
  • Ability to analyse technical problems and propose solutions in a manufacturing environment.
  • 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 shaping the future of robotic surgery.
  • A fast-growing company where innovation meets agility.
  • Structured onboarding program and training.
  • High degree of autonomy and flexibility.

Questions fréquentes

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Source : ats:workable

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Distalmotion SA

Épalinges