Job Title: NPI Engineer
All the relevant skills, qualifications and experience that a successful applicant will need are listed in the following description.
Type: 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. xqknzec
* Takes a logical and pragmatic approach to problem-solving.