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Robotics Manufacturing Engineer

Distalmotion SA · Épalinges

New
Onsite Mid 🇬🇧 English
SolidWorks ISO 13485 pFMEA DFM IQ/OQ/PQ tolerance stack-up

Job description

About the role

The Robotics Manufacturing Engineer drives industrialization and manufacturing engineering for the Dexter surgical robot and its accessories, ensuring smooth production in a regulated ISO 13485 environment.

Key responsibilities

  • Act as the manufacturing link between the CMO, supply chain, quality, and R&D, supporting commercial ramp‑up.
  • Perform level‑2 production troubleshooting and mechanical root‑cause analysis on complex electromechanical assemblies.
  • Initiate and execute Change Requests and Design Transfers within the regulated QMS.
  • Edit SolidWorks drawings, assemblies and BOMs to reflect manufacturing changes and manage revisions.
  • Contribute to pFMEA, DFM reviews, work instructions, inspection plans and participate in IQ/OQ/PQ execution.
  • Maintain and calibrate manufacturing tools and test equipment at the CMO site.
  • Train CMO personnel on updated processes and drive continuous improvement.
  • Ensure compliance with norms, regulations and maintain QMS documents and Device History Records.

Required profile

  • MSc or BSc in mechanical or mechatronics engineering.
  • 3–6 years experience in Class II medical device manufacturing.
  • Hands‑on experience with complex electromechanical assemblies in production.
  • Working knowledge of ISO 13485 and change‑control execution.
  • Comfortable operating with indirect authority at a CMO site and fluent English.

Required skills

  • SolidWorks (sustaining level: editing drawings, assemblies, BOMs).
  • Mechanical integration: tolerance stack‑up, interference assessment.
  • ISO 13485 compliance and change‑control processes.
  • pFMEA and DFM analysis.
  • IQ/OQ/PQ execution and reporting.

What we offer

  • Dynamic, innovative environment with cutting‑edge medical technology.
  • Structured onboarding program and training.
  • High degree of autonomy and flexibility.

Questions fréquentes

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Source : ats:workable

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Published 6 hours ago

Expires 1 month from now

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Distalmotion SA

Épalinges