Job Title: NPI EngineerType: Contract (6-monhts initially, potential extension)Location: Hasselt, Belgium (hybrid, 3 days per week onsite)
Responsibilities:Support internal product change management and non-conformance handling.Draft procurement-related business cases and work orders, raise PRs and track POs to closure.Provide clear communication and oversight to suppliers, and key Contract Manufacturing partners, travel on-site as needed.Ensure completeness of Medical Device File by working with quality counterparts and suppliers.Report activities and progress in a timely manner to Manager.Other activities as assigned to support NPI work in projects.
Requirements:Must have experience with Class II/III medical devices.Experience in fast-moving project environments in medical devices/pharmaceutical industry under ISO 13485 and/or 21 CFR part 820 guidance framework.Degree in Biomedical engineering or other related engineering degrees.Ability to create a mental map of issues and express thoughts in a clear and concise manner.Ability to navigate ambiguity by asking the right questions.Ability to apply theories and experience in a practice, at work.Takes a logical and pragmatic approach to problem-solving.