Take the lead on the project while being fully involved in its hands-on operational execution.
Perform impact assessments per SKU to identify the elements that need to be updated (bill of materials, routings, item master, etc.).
Pilot the update of labels and packaging artworks (the physical packaging itself does not change, but the graphic elements may evolve), as well as Instructions for Use (IFUs).
Contribute to the update of Design History Files (DHF) and Device Master Records (DMR), work instructions, and manufacturing documentation.
Ensure coordination with Regulatory Affairs and Quality to guarantee that their requirements are fully taken into account as part of the change.

Engineer with at least 5 years of proven experience in the medical device industry (ISO 13485 environment).
Strong proficiency in technical documentation and change management (Change Control).
Experience with labeling / artwork and ERP systems is highly appreciated.
Ability to work cross-functionally with Quality, Regulatory Affairs, and Production.
Excellent level of English, both spoken and written (mandatory) and fluent French.
Comfortable working with stakeholders based in USA, managing a 9-hour time difference.
Available for travel to USA.

Senior Engineer - Legal Manufacturer Change

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