Project Engineer

Project Engineer –Equipment Transfer

Location: Noblesville, IN 

Position Overview

Ambu is seeking a highly motivated Project Engineer to support a large-scale capital equipment transfer project involving the relocation of a medical device production line. This individual will play a key role in planning, coordinating, and executing activities associated with a $1.8 million equipment transfer initiative, ensuring projects are completed on schedule, within scope, and in compliance with quality and regulatory requirements.

The Project Engineer will work closely with cross-functional teams including Manufacturing Engineering, Quality, Validation, Operations, Supply Chain, and Regulatory Affairs to manage project deliverables throughout the transfer lifecycle. This role requires strong project management skills, validation exposure, and the ability to drive progress using Agile/Scrum methodologies in a regulated medical device environment.

Key Responsibilities

· Lead and coordinate activities associated with the transfer of manufacturing equipment and production processes between facilities.

· Develop and manage project plans, timelines, milestones, and deliverables to ensure successful project execution.

· Facilitate and manage change control activities in accordance with company quality system requirements.

· Collaborate with cross-functional stakeholders to identify project risks, dependencies, and mitigation strategies.

· Support all phases of equipment implementation, including commissioning, qualification, validation, and production readiness activities.

· Ensure project activities meet applicable medical device regulations, quality standards, and internal procedures.

· Drive project execution using Agile and Scrum methodologies, facilitating project meetings, status updates, and issue resolution.

· Coordinate documentation and approvals for validation protocols, reports, and associated project records.

· Monitor project performance, communicate progress to leadership, and escalate issues when necessary.

· Support continuous improvement initiatives and process optimization efforts throughout the transfer project.

Required Qualifications

· Bachelor's degree in Engineering or a related technical discipline.

· Minimum of 3 years of project engineering, project management within the medical device industry.

· Experience leading and managing engineering or capital equipment projects in a regulated environment.

· Working knowledge of equipment qualification and validation activities, including commissioning, IQ/OQ/PQ, and process validation concepts.

· Experience managing or participating in change control processes.

· Strong understanding of project planning, scheduling, and execution methodologies.

· Excellent communication and stakeholder management skills with the ability to work effectively across multiple functional groups.

· Strong organizational, problem-solving, and decision-making abilities.