Project Engineer

About the role

PurposeBD is seeking a Project Engineer to lead planning, execution and implementation of engineering projects within its medical‑technology manufacturing environment. The role supports process engineers, drives equipment installation, validation and continuous improvement on the shop floor.

Key responsibilities

• Plan, schedule and coordinate technical and managerial aspects of engineering projects to meet deadlines.
• Install manufacturing equipment, provide training and technical support to process engineers and production staff.
• Develop and execute validation protocols, engineering studies and Design of Experiments (DOE).
• Create preventive maintenance strategies, monitor performance metrics such as yield, waste and machine efficiency, and recommend improvements.
• Serve as the primary liaison between Engineering, Maintenance and Manufacturing during equipment or process upgrades.
• Ensure compliance with federal, state, local regulations and corporate quality policies (ISO 9000, QSR).

Required profile

• Bachelor’s degree in Mechanical, Electrical or Biomedical Engineering.
• Minimum three years of experience in medical‑device or pharmaceutical manufacturing.
• Familiarity with ISO 9000, Quality Systems Regulation (QSR) and software validation.
• Bilingual in Spanish and English.
• Willingness to relocate temporarily to Juncos for a three‑month training period.

Required skills

• Statistical techniques and Design of Experiments (DOE).
• Lean Six Sigma methodology with certification.
• Project management and validation protocol development.
• Software validation experience.
• CIAPR license or Engineer‑in‑Training (EIT) designation.
• Knowledge of preventive maintenance and equipment performance monitoring.