Senior Engineer - Legal Manufacturer Change (LMC) in Neuchâtel

Senior Engineer - Legal Manufacturer Change (LMC) in Neuchâtel

Neuchâtel Vollzeit Vor Ort
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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.

Senior Engineer - Legal Manufacturer Change (LMC) in Neuchâtel Arbeitgeber: InGoedeBanen.nl

Unser Unternehmen bietet Ihnen als Kältesystem-Monteur / Mechatroniker Kältetechnik / Servicetechniker (w/m/d) eine herausragende Arbeitsumgebung, die von Teamgeist und Innovation geprägt ist. Wir fördern Ihre berufliche Weiterentwicklung durch gezielte Schulungen und bieten Ihnen die Möglichkeit, an spannenden Projekten in der Kälte- und Klimatechnik zu arbeiten. Zudem profitieren Sie von flexiblen Arbeitszeiten und einem attraktiven Vergütungspaket, das Ihre Leistungen wertschätzt.

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