Medical Device Production Engineer — ECO/NPI & Onsite Lead

HC1374 BK Medical ApS; Herlev Kommune; On-site; DKK 700,000 - 900,000; Full time

Job summary

GE HealthCare seeks a hands-on Production Engineer - Project Engineer to join the manufacturing site in Herlev, Denmark. The role spans ECO/NPI, NC/INV/CAPA, and equipment qualification while working with operators and SMEs on the production floor.

You will implement process changes, lead trials, collect data, and ensure robust documentation and validation across GMP-compliant environments.

Qualifications

• Bachelor's degree in Engineering or related technical discipline.
• Experience with ECO/NPI and manufacturing changes.
• Familiarity with NC/INV/CAPA workflows and root cause analysis.
• Knowledge of GMP and risk management in manufacturing.
• Experience in medical device manufacturing is preferred.

Responsibilities

• Lead ECO implementation and manufacturing change activities from assessment to closure.
• Coordinate first builds and production trials with process updates.
• Troubleshoot on the shop floor with operators to verify solutions.
• Own NC, INV, and CAPA activities including investigations and corrective actions.
• Support Equipment Qualification and Process Validation planning and reporting.
• Ensure documentation, validation, and traceability for changes.

Skills

Manufacturing engineering

ECO/NPI implementation

Root cause analysis

Quality System workflows

Cross-functional collaboration

Process validation

Documentation discipline

Problem solving

Education

Bachelor's degree in Engineering

Tools

TrackWise

Job description

GE HealthCare seeks a hands-on Production Engineer - Project Engineer to join the manufacturing site in Herlev, Denmark. The role spans ECO/NPI, NC/INV/CAPA, and equipment qualification while working with operators and SMEs on the production floor.

You will implement process changes, lead trials, collect data, and ensure robust documentation and validation across GMP-compliant environments.