About the Role: We are looking for a Maintenance Engineer to support and improve the reliability and performance of manufacturing equipment at a medical device production site in Nijmegen. In this role, you will be responsible for troubleshooting, repairs, preventive maintenance, and driving continuous improvement to ensure safe and efficient operations in a regulated environment. Key Responsibilities:
Develop and implement effective maintenance and reliability strategies for manufacturing equipment.
Troubleshoot, repair, and maintain complex machinery on the production floor.
Train and support technicians in equipment handling, diagnostics, and best practices.
Resolve equipment-related quality issues and help prevent reoccurrence.
Manage spare parts inventory to ensure critical components are available for timely repairs.
Liaise with external equipment and tooling suppliers to develop and implement technical solutions.
Plan and execute calibration and preventive maintenance activities with full compliance.
Support equipment validation efforts (URS, FAT, SAT) and adopt supplier recommendations where applicable.
Maintain clear documentation and ensure compliance with quality, safety, and environmental regulations.
Communicate risks, issues, and opportunities to Engineering Management.
Carry out additional engineering tasks as needed.
Requirements:
Bachelor’s Degree in Engineering or related field (Life Sciences also considered).
2–4 years of experience in a regulated manufacturing environment, ideally in medical devices or pharmaceuticals.
Strong knowledge of GMP, maintenance best practices, and manufacturing processes.
Experience with equipment and process validation (URS/FAT/SAT).
Ability to interpret and integrate vendor documentation into operational processes.
Project management and process improvement experience is a plus.
Strong problem-solving and communication skills.
Fluent in English (spoken and written); Dutch is a plus.