Engineering Project Manager

Engineering Project Manager role at a medical device manufacturing facility overseeing site engineering projects, equipment validation, and capital initiatives. Requires leadership of engineering teams while ensuring compliance with FDA regulations, GMP, and ISO standards to support supply chain integrity and patient safety.

Responsibilities

• Manage and execute site engineering projects including equipment qualifications, process validations, and efficiency improvements
• Supervise and support engineering team through scheduling, training, operations coordination, and performance management
• Develop engineering deliverables such as process specifications, drawings, and validation activities (IQ, OQ, PQ, PV)
• Track projects against timelines, budgets, and performance targets aligned with capital plan objectives
• Collaborate with cross-functional teams and contractors on facility improvements and process changes

Requirements

• Bachelor's degree in Engineering or technical field with 3+ years experience, or Master's degree with 2+ years
• Leadership experience managing projects or direct reports
• Strong written and verbal communication skills
• Experience in regulated manufacturing environment (medical device or pharmaceutical preferred)
• Knowledge of project budgets, financial considerations, and cost analysis
• Proficiency in Microsoft Office and data analysis or statistical tools
• Basic understanding of health, safety, and environmental regulations

Compensation: $62,000.00 - $85,000.00 USD base