Production Engineer – Project Engineer (1)

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

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Additional Information