Project Engineer

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.
• Care for 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.

Requirements

• Bachelor's degree in Engineering or a related technical discipline.
• Minimum of 3 years of project engineering or project management experience 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.