Project Coordinator - Engineering

Basic American Medical Products•Fond du Lac, WI

41d

About The Position

GF Health Products, Inc.'s ("GF") Basic American Medical Products facility is in search of a highly organized and detail-oriented Project Coordinator to join our Engineering team. This position is responsible for overseeing 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.

Requirements

Bachelor's or associate degree in Engineering Technology, Project Management, Business or a related technical field.
Minimum of 1+ years of project management experience within 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.

Nice To Haves

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

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 resources 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.