Project Engineer

We are seeking a Project Engineer to lead the planning, design, and execution of construction and facility improvement projects within the medical device industry.

This role combines technical leadership and project management , ensuring compliance with quality, safety, and regulatory standards such as GMP, FDA, and ISO 13485 .

Key Responsibilities

• Lead the planning, design, and execution of construction and renovation projects, including cleanrooms, utilities, production areas, and offices.
• Manage project schedules, budgets, and resources, ensuring timely delivery of key milestones.
• Ensure full compliance with Good Manufacturing Practices (GMP) , FDA , ISO 13485 , and company EHS standards.
• Review and validate technical specifications, engineering drawings, and construction packages.
• Collaborate with contractors, architects, and consultants to align designs with operational and regulatory needs.
• Support commissioning, qualification, and validation activities for facility systems and utilities.
• Lead Design for Manufacturability (DFM) and product / process transfer to commercial manufacturing.
• Prepare and present technical reports, project updates, and risk assessments to senior leadership.
• Provide input on re-engineering opportunities to improve process performance and product quality.
• Mentor engineers and provide technical guidance to cross-functional teams.
• Oversee installation and validation of new or existing production lines, ensuring regulatory compliance.

Requirements

Qualifications