Engineering Project Coordinator - On-Site

About the role

GF Health Products, Inc.'s Basic American Medical Products facility is seeking a highly organized and detail-oriented Project Coordinator to join the Engineering team. This position oversees cross-functional projects within a regulated medical device manufacturing environment, ensuring projects are completed on time, within scope and budget, and in compliance with applicable regulatory and quality requirements.

Responsibilities

• Coordinate engineering projects from initiation through implementation and closure.
• Coordinate cross-functional teams including Engineering, Quality, Regulatory, Operations, Purchasing, Manufacturing, and Supply Chain.
• Develop and maintain project timelines, budgets, milestones, and resource plans.
• Monitor project schedules and ensure timely completion of tasks across teams.
• Ensure compliance with applicable medical device regulations, company quality systems, and internal procedures.
• Support product development through sustaining engineering documentation, identification of cost-reduction opportunities, process improvements, and assistance with transferring projects to manufacturing.
• Facilitate project meetings and drive accountability for deliveries and action items.
• Identify project tasks and assist with developing mitigation plans to minimize impact to timelines and business objectives.
• Assist with engineering change management activities, including documentation and implementation tracking.
• Collaborate with Quality and Regulatory teams to support validation activities, audits, and compliance initiatives.
• Maintain accurate project documentation and records in accordance with company and regulatory requirements.

Requirements

• Bachelor's or associate degree in Engineering, Engineering Technology, Project Management, Business, or a related technical field.
• Minimum of 1+ years of project management experience within a manufacturing environment.
• Strong understanding of project management principles, scheduling, and risk management.
• Experience coordinating cross-functional teams and managing multiple priorities.
• Strong organizational, communication, and problem-solving skills.
• Proficient in Microsoft Office Suite and project management tools.

Qualifications

• Preferred: PMP certification or formal project management training.
• Preferred: Experience working in medical device, healthcare, pharmaceutical, or other FDA-regulated industries.
• Preferred: Experience supporting engineering change requests (ECRs), validation activities, or product lifecycle management.
• Preferred: Experience within a medical device manufacturing environment.

Benefits

• Comprehensive health, dental, and vision insurance plans.
• 401(k) with company match.
• Paid vacation, holidays, and personal days.
• Paid life insurance, employee assistance program, and short-term disability.