Production Engineer – Project Engineer (1)

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

Job Description Summary

The Production Engineer - Project Engineer works 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 supports manufacturing across scanner/system assembly, mechanical and electrical/electronic assembly, software configuration and loading, packaging and labeling, and testing/final acceptance. This is a hands-on manufacturing engineering role, working directly with operators, technicians, engineers, and SMEs on the production floor to troubleshoot issues, execute trials and first builds, collect and evaluate data, implement process changes, and verify solutions in the actual manufacturing environment The position combines practical manufacturing engineering with three core areas: ECO/NPI implementation and manufacturing readiness; NC, INV and CAPA activities and Equipment Qualification/Process Validation.

Job Description

This is an onsite opportunity at our manufacturing site in Herlev, Denmark.

Roles & Responsibilities

• Lead ECO implementation, NPI, and manufacturing change activities from production impact assessment and cut-in strategy through implementation and closure.
• Coordinate first builds and production trials, including process updates, SOP/WI changes, training, data and evidence collection, and implementation reporting.
• Work hands-on with operators and technicians on the production floor to troubleshoot manufacturing issues, implement process changes, and verify solutions.
• Own and drive NC, INV, and CAPA activities (TrackWise), including investigations, root cause analysis, corrective actions, implementation, effectiveness checks, and closure.
• Facilitate root cause investigations and define corrective actions together with Quality, Engineering, Manufacturing, and relevant SMEs.
• Lead and support Equipment Qualification and Process Validation, including risk assessments, validation planning, protocol execution, documentation, and reporting.
• Support URS, IQ/OQ/PQ, equipment qualification, test method validation, revalidation, and ongoing process review, as applicable.
• Develop and improve manufacturing processes using pFMEA, Control Plans, risk management, process controls, and continuous improvement.
• Ensure manufacturing changes, investigations, equipment, and processes are appropriately documented, controlled, validated, traceable, and audit-ready.

Required Qualifications

• Bachelor's degree in Engineering or a related technical discipline, or equivalent relevant experience.
• Experience with manufacturing engineering, ECO implementation, NPI, or sustaining engineering.
• Experience with NC, INV, CAPA, root cause analysis, and Quality System workflows.
• Experience with or strong understanding of Equipment Qualification and Process Validation.
• Knowledge of GMP, Quality Management Systems, risk management, and manufacturing process controls.
• Experience working in medical device or other regulated manufacturing environments.
• Proven ability to work cross-functionally across Engineering, Manufacturing, and Quality.

Desired Characteristics (nice to have)

• Hands-on experience with medical device manufacturing and manufacturing process development/improvement.
• Strong project execution and manufacturing change implementation skills.
• Strong analytical, problem-solving, and root cause investigation capabilities.
• Experience with equipment qualification, process validation, and risk-based manufacturing activities.
• Structured and disciplined approach to documentation, workflows, actions, and deadlines.
• Proactive and solution-oriented with strong ownership and accountability.
• Strong cross-functional collaboration and communication skills.
• Ability to balance ECO/NPI, Quality System activities, validation, compliance, and production priorities

#LI-ONSITE #LI-BJ1

Additional Information

Relocation Assistance Provided: No At GE HealthCare, we see possibilities through innovation. We're partnering with our customers to fulfill healthcare's greatest potential through groundbreaking medical technology, intelligent devices, and care solutions. Better tools enabling better patient care. Together, we are not only building a healthier future but living our purpose to create a world where healthcare has no limits.