For a big medical device company in Leiden area we are looking for a staff engineer NPI. We are seeking an experienced professional to lead various projects related to product lifecycle management (LCM) or new product introduction (NPI) within the MedTech industry. This role involves cross-departmental collaboration to ensure product changes comply with GMP/ISO standards while driving process improvements, cost reductions, and product introductions.
Responsibilities:
Oversee multiple projects ensuring safety, regulatory compliance, and adherence to company standards.
Provide technical support and coordinate material sourcing and transition for new and existing products.
Lead labeling design projects in collaboration with global and local teams to meet regulatory requirements.
Manage product lifecycle documentation and change control processes.
Collaborate with cross-functional teams for the introduction of new products and support commercial launches.
Coordinate responses to product issues, working with R&D, Marketing, and Regulatory Affairs.
Ensure product UDI compliance and manage design change projects globally.
Analyze data and apply statistical methods to assess product performance and risks.
Ensure compliance with safety requirements and Good Manufacturing Practices (GMP).
Requirements:
Bachelor's or Master’s degree in an engineering discipline.
6-8 years of experience in engineering or packaging, preferably in the medical device sector.
Fluent in English, with strong communication skills across all mediums.
Proven leadership and project management skills, with a focus on collaboration across time zones.
Strong technical background, including proficiency with MS Office and project management software.
Experience in manufacturing standards and a solid understanding of GMP, GDP, and data integrity practices.
Ability to manage complex, cross-functional projects and adapt to changing priorities.
INTERESTED? If you’re interested in the above description, please apply with your CV today. For further information, please contact Jane Tiemessen at +31 (0)20 20 44 502 or by email at j.tiemessen@panda-int.com