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.
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