Service Project Engineering

360Pharma; Netherlands; On-site; EUR 65,000 - 95,000; Full time

Job summary

360Pharma is seeking a Service Project Engineer to support growth and operational excellence across EMEA Service Centers by developing, validating, and improving service and repair processes for capital medical devices.

You will lead engineering workstreams, onboarding new products, and providing hands-on technical support to ensure processes, equipment, and documentation meet safety, quality, cost, and delivery requirements in collaboration with the Service & Repair Manager and international

Qualifications

• Bachelor’s degree in an engineering discipline related to manufacturing or industrial engineering.
• Experience in process development, equipment support, validation, and technical documentation.
• Experience coordinating deliverables across multiple stakeholders in a regulated environment.

Responsibilities

• Design, develop, implement, and continuously improve service and repair processes for safe, compliant operations.
• Support onboarding of new products and service volumes across EMEA service centers.
• Plan and execute computer system validation, equipment qualification, and process validation (IQ/OQ/PQ).
• Lead engineering projects of low to medium complexity and participate in cross-functional projects.
• Manage project scope, deliverables, schedules, risks, resources, and costs with clear status updates.

Skills

Process development

Equipment support

Validation

Cross-functional coordination

Education

Bachelor’s degree in Manufacturing/Mechanical/Industrial Engineering

Tools

MS Office

Job description

Position Overview

The Service Project Engineer supports the growth and operational excellence of the EMEA Service Centers by developing, validating, and improving service and repair processes for capital medical devices.The role supports the onboarding of new products and additional service volumes, leads engineering workstreams, and provides hands-on technical support to ensure that processes, equipment, and documentation meet applicable safety, quality, cost, and delivery requirements.Working closely with the Service & Repair Manager and cross-functional partners, the Service Project Engineer combines process engineering, project execution, validation, problem solving, and continuous improvement. The role requires adaptability, sound engineering judgment, clear communication, and the ability to support a broad and evolving service portfolio.

Tasks & Responsibilities

• Design, develop, implement, and continuously improve service and repair processes to support safe, compliant, efficient, and cost-effective operations.
• Support the introduction of new products, technologies, and service volumes across the EMEA Service Centers, including process definition, equipment readiness, documentation, and operational handover.
• Plan and execute Computer System Validation, equipment qualification, and process validation activities, including IQ, OQ, and PQ, in accordance with applicable procedures and quality requirements.
• Lead engineering projects of low to medium complexity and represent Service & Repair as a core team member on larger cross-functional projects.
• Manage project scope, deliverables, schedules, risks, resources, and costs, while preparing status updates and communicating progress or escalations to stakeholders and management.
• Provide technical support for equipment design and development, material and process testing, specifications, operator instructions, process studies, investigations, and technical documentation.
• Perform troubleshooting, root cause analysis, risk assessments, gage and measurement system analyses, and structured problem solving to address process, product, equipment, and quality issues. Provide day-to-day engineering support across the service portfolio, which may include Power Tools, Sports, VELYS Robotics, packaging, and other capital equipment platforms.

Qualifications & Experience

• Bachelor’s degree from an accredited institution in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or a comparable engineering discipline.
• Minimum of 4 years of relevant experience in manufacturing engineering, process engineering, project engineering, or capital equipment service.
• Demonstrated experience in process development, equipment support, troubleshooting, validation, and technical documentation.
• Experience contributing to or leading engineering projects and coordinating deliverables across multiple stakeholders.
• Experience working in a regulated industry, preferably within the medical device industry.
• Experience with Computer System Validation and/or process validation, including IQ, OQ, and PQ, is preferred.
• Six Sigma or Lean Six Sigma certification, practical Lean experience, or project management experience is preferred.
• Professional proficiency in English and Dutch is required. Working knowledge of German is considered an advantage.

Knowledge, Skills & Capabilities

• Strong written, verbal, and presentation skills, with the ability to communicate technical information clearly to both technical teams and management.
• Strong organizational skills, attention to detail, and a results-oriented approach.
• Effective troubleshooting, analytical thinking, risk assessment, and data-based decision-making skills.
• Proficiency in Microsoft Office applications and relevant databases or digital systems.
• Ability to work independently while collaborating effectively within cross-functional and international teams.
• Proactive, flexible, and open-minded approach, with the ability to manage varied priorities in a changing environment.
• High standards of professionalism, integrity, ethics, quality, compliance, and safety.