Senior NPI Engineer – MedTech, Hybrid Leiden

Sentior, Ltd.; Leiden; Hybrid; EUR 83,000 - 117,000; Full time

Job summary

Johnson & Johnson Mentor in Leiden is seeking an NPI Engineer to lead new product introductions and manufacturing processes for class III medical implants. The role combines project management, cross-functional collaboration, and strict GMP/ISO 13485 compliance in a fast-paced MedTech environment.

You will set timelines, write protocols, support packaging and labeling, and ensure design controls are transferred to production.

Qualifications

• Bachelor’s or Master’s degree in an engineering discipline and 3–5 years in a regulated environment.
• Fluent English reading, writing and speaking skills are required.
• Experience working across time zones and leading projects.
• Strong knowledge of GMP, GDP, DI and ISO 13485 principles.

Responsibilities

• Plan, document and execute new process development and validations for NPI.
• Lead cross-functional projects across R&D, regulatory and manufacturing.
• Create timelines, protocols, reports and transfer processes to production.
• Ensure compliance with GMP/ISO and design control requirements.

Skills

English fluency

Project management

Cross-functional teamwork

GMP knowledge

Education

Bachelor's or Master’s in engineering

Tools

MS Office

MS Project

PowerPoint

Excel

Adobe Suite

Job description

Johnson & Johnson Mentor in Leiden is seeking an NPI Engineer to lead new product introductions and manufacturing processes for class III medical implants. The role combines project management, cross-functional collaboration, and strict GMP/ISO 13485 compliance in a fast-paced MedTech environment.

You will set timelines, write protocols, support packaging and labeling, and ensure design controls are transferred to production.