Medical Device Project Engineer - Process & Validation

BD; Añasco (PR); On-site; USD 65,000 - 90,000; Full time

Job summary

BD is seeking a Project Engineer to plan, execute, and implement engineering projects. You will support Process Engineers in troubleshooting and optimizing manufacturing equipment and coordinate transfers of equipment and processes as needed.

The role includes performing validation processes and ensuring compliance with quality standards. Minimum requirements include a BS in Engineering and at least 3 years of experience in medical device or pharmaceutical manufacturing, with ISO 9000 and QSR

Qualifications

• BS in Engineering or equivalent, with relevant manufacturing background.
• Experience in medical devices or pharmaceutical environments is preferred.
• Bilingual in Spanish and English.

Responsibilities

• Plan, schedule, and coordinate complex engineering projects.
• Lead machine improvement and uptime initiatives on the manufacturing floor.
• Install equipment and provide training and technical support to engineers and staff.
• Develop and execute validation protocols, DOE, and engineering studies.
• Create preventive maintenance strategies and monitor performance metrics.
• Serve as liaison among Engineering, Maintenance and Manufacturing during implementations.
• Ensure compliance with Federal, State, and Local regulations and corporate policies.

Skills

Project management

Manufacturing experience

Process engineering

Education

BS in Engineering

Job description

BD is seeking a Project Engineer to plan, execute, and implement engineering projects. You will support Process Engineers in troubleshooting and optimizing manufacturing equipment and coordinate transfers of equipment and processes as needed.

The role includes performing validation processes and ensuring compliance with quality standards. Minimum requirements include a BS in Engineering and at least 3 years of experience in medical device or pharmaceutical manufacturing, with ISO 9000 and QSR