Manufacturing Engineer - Medical Device NPI & ECO Lead

GE HealthCare (United States); København; Sur place; DKK 600 000 - 800 000; Plein temps

Résumé du poste

GE HealthCare in Herlev, Denmark, is seeking a Production Engineer – Project Engineer to work hands-on with manufacturing and cross-functional teams to implement product and process changes for medical devices used in ultrasound, surgical visualization, and image-guided procedures. The role covers scanner/system assembly, mechanical/electrical assembly, software config, packaging, labeling, and testing.

You will troubleshoot on the floor, drive ECO/NPI, CAPA, and qualification activities, and

Qualifications

• Bachelor's degree in Engineering or a related technical discipline.
• Experience with ECO/NPI, or sustaining engineering.
• Experience with NC, INV, CAPA, root cause analysis, and Quality System workflows.
• Knowledge of Equipment Qualification and Process Validation.
• Experience in medical device manufacturing environments.

Responsabilités

• Lead ECO/NPI and manufacturing change activities from assessment through closure.
• Coordinate first builds and production trials, including process updates and documentation.
• Troubleshoot manufacturing issues on the production floor and verify solutions.
• Own NC, INV, and CAPA activities (TrackWise) including investigations and corrective actions.
• Lead equipment qualification and process validation activities with risk assessments and reporting.

Connaissances

Cross-functional collaboration

Root cause analysis

GMP knowledge

Quality Systems

Medical device manufacturing

Formation

Bachelor's degree in Engineering or related field

Description du poste

GE HealthCare in Herlev, Denmark, is seeking a Production Engineer – Project Engineer to work hands-on with manufacturing and cross-functional teams to implement product and process changes for medical devices used in ultrasound, surgical visualization, and image-guided procedures. The role covers scanner/system assembly, mechanical/electrical assembly, software config, packaging, labeling, and testing.

You will troubleshoot on the floor, drive ECO/NPI, CAPA, and qualification activities, and