Senior NPI Engineer - Medical Device Launch & Process

Freudenberg Group; Spiddal; On-site; EUR 70,000 - 110,000; Full time

Benefits offered by this job

Flexible Work Models

Company Pension

Education Reimbursement

Personal Development

Job summary

Freudenberg Medical Ireland Ltd. is recruiting an engineer to join a regulated medical device manufacturing environment. The role focuses on developing, validating and transferring precision manufacturing processes, including laser welding and laser cutting, into high-volume production.

You will contribute to NPIs, support IQ/OQ/PQ activities and apply Lean Six Sigma tools to drive continuous improvement while ensuring compliance with ISO 13485 standards and robust technical documentation.

Qualifications

• 5+ years engineering experience in medical device or regulated manufacturing.
• Experience developing, optimising and transferring manufacturing processes to production.
• Experience supporting NPI programmes in ISO 13485 environment.
• Strong understanding of DOE, Gauge R&R, and process capability studies.

Skills

Problem-solving

Communication

Education

Level 8 degree or higher in Mechanical/Manufacturing/Mechatronics/Biomedical Engineering

Tools

Laser welding

Laser cutting

DOE

Gauge R&R

Process validation IQ/OQ/PQ

Lean Six Sigma

Job description

Freudenberg Medical Ireland Ltd. is recruiting an engineer to join a regulated medical device manufacturing environment. The role focuses on developing, validating and transferring precision manufacturing processes, including laser welding and laser cutting, into high-volume production.

You will contribute to NPIs, support IQ/OQ/PQ activities and apply Lean Six Sigma tools to drive continuous improvement while ensuring compliance with ISO 13485 standards and robust technical documentation.