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Senior Engineer - Legal Manufacturer Change (LMC)

Randstad · Neuchatel, Neuchatel

HybridFixed termSeniorFREN
Mandated by our client, a fast-growing international MedTech company, we are seeking a Senior Engineer - Legal Manufacturer Change (LMC).   Location: Neuchâtel, Switzerland (Hybrid: approx. 2 days per week on-site) Contract Type: 18-month(CDD) with extension possibility Travel Requirements: Frequent travel to the USA ( 25%) Languages Required: Excellent English (mandatory) & Fluent French Start Date: ASAP   Key Responsibilities:   - 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. Required Profile:   - 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.   working at null

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