Equipment Development Engineer

Job description

Summary

The Equipment Development Engineer will lead equipment development and automation projects that support site and global strategic objectives. The role focuses on equipment design, validation, integration, risk management, and lifecycle support within a regulated manufacturing environment.

Responsibilities

• Lead equipment development, automation, and integration projects from concept through implementation.
• Manage equipment vendors, including selection, qualification, and ongoing performance.
• Oversee equipment validation activities, including URS, FDS, SDS, FAT, SAT, IQ, and software validation.
• Drive projects supporting key business objectives, including safety, cost reduction, efficiency improvements, and obsolescence management.
• Conduct equipment risk assessments and implement mitigation plans throughout project lifecycles.
• Identify and manage equipment, tooling, component, and software obsolescence programs.
• Ensure equipment is designed and implemented in accordance with safety and ergonomic standards.
• Support Manufacturing with scale-up activities and new equipment integration.
• Manage equipment changes through formal change control and Management of Change (MOC) processes.
• Provide technical leadership and project updates to stakeholders while supporting continuous improvement initiatives.

Experience

• Degree qualification (Level 8 or equivalent) in Engineering or a related discipline.
• Proven experience in equipment development, automation, and validation within a regulated manufacturing environment.
• Experience with equipment and software validation methodologies, including GAMP 4/5 standards.
• Knowledge of GMP and ISO 13485 requirements, preferably within the Medical Device industry.
• Experience with equipment risk assessments, process validation, and change management.
• Familiarity with PLCs, electrical systems, and IT/OT integration is advantageous.
• Exposure to Lean Manufacturing and Six Sigma methodologies is desirable.
• Strong project management, problem-solving, and stakeholder management skills.
• Ability to manage multiple projects and communicate effectively across cross-functional team