Senior Engineer - Legal Manufacturer Change in Neuchâtel

Senior Engineer - Legal Manufacturer Change (LMC)

Jobdescription

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.

Sardo

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