New Product Introduction Engineer

Job Title: NPI Engineer

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.
• Takes a logical and pragmatic approach to problem-solving.