Robotics Manufacturing Engineer
About this role
The Robotics Manufacturing Engineer drives industrialization and manufacturing engineering for the Dexter surgical robot and its accessories by owning mechanical and mechatronic sustaining engineering, manufacturing testing, root-cause analysis of manufacturing issues, and design transfer. The role operates in a regulated ISO 13485 environment, with the CMO as the primary production site.
Duties and Responsibilities:
Act as the manufacturing link between the CMO, supply chain, quality and R&D (HQ), and support the commercial ramp-up of Dexter production.
Perform level-2 production troubleshooting and mechanical root-cause analysis on complex electromechanical assemblies.
Initiate and execute Change Requests, and associated Design Transfers, end-to-end in the regulated QMS, assess change impact on technical and quality aspects.
Edit existing SolidWorks drawings, assemblies and BOMs to reflect manufacturing-level changes and submit rev-ups to R&D for review and approval.
Contribute to pFMEA, DFM reviews, work instruction authorship and inspection plans; participate in IQ/OQ/PQ execution and reporting.
Maintain manufacturing tools and test equipment and ensure they remain properly calibrated at the CMO site.
Train CMO personnel on updated processes and documentation, and drive best practices and continuous improvement on the line.
Ensure compliance with applicable norms and regulations, and maintain QMS documents and records — including Device History Records (DHR) capturing all Dexter robot configurations
Requirements
- Work Experience and Education requirements:
- MSc or BSc with relevant experience in mechanical or mechatronics engineering.
- 3–6 years in medical device manufacturing (Class II).
- Hands-on experience with complex electromechanical assemblies in production.
- Working knowledge o