Job Description
Job Summary:
AQUABILITI
is a medical device company that produces pre-filled IV flush syringes and water-based products. Under the direct supervision of the Project Engineering Manager, the Manufacturing Engineer will be responsible for the day-to-day management of all site engineering, maintenance, and repair activities. This position is responsible for developing, implementing, and managing process improvement projects, as well as evaluating innovation opportunities to advance the corporation's quality and financial performance. Essential Responsibilities/Functions:
To perform this job successfully, an individual must be able to perform each essential function satisfactorily: Provide hands on troubleshooting, repair coordination, and technical support for aging and legacy manufacturing equipment to minimize downtime and maintain production continuity Lead root cause failure analysis on equipment breakdowns and implement corrective actions to improve equipment reliability and reduce repeat failures Develop and oversee preventive and predictive maintenance programs to improve overall equipment effectiveness and extend asset life Manage repair activities for obsolete or hard to source components, including identifying retrofit solutions and alternative parts strategies Oversee and work closely with the maintenance team, providing technical guidance, prioritization support, and coordination to ensure timely resolution of mechanical, electrical, and controls related equipment issues across manufacturing operations Work closely with Quality and cross functional teams to support development, implementation, and maintenance of manufacturing processes for new and existing products, including validation activities (IQ, OQ, PQ) Support equipment selection, installation, qualification, and ongoing lifecycle management for manufacturing and packaging systems Troubleshoot complex manufacturing and equipment issues, identifying root causes and implementing corrective and preventive actions Collaborate with Quality Assurance, Regulatory Affairs, and Production teams to ensure compliance with FDA, ISO
13485, and other applicable standards Develop and maintain standard operating procedures, work instructions, and engineering documentation Manage capital projects including scope definition, budgeting, installation, and commissioning of new equipment or facility upgrades Education and Experience:
3+ years manufacturing engineering or maintenance engineering experience Bachelor's degree in Mechanical, Manufacturing, Industrial, or related Engineering field Hands on troubleshooting and repair of manufacturing equipment required Strong computer skills required, with ability to quickly learn and utilize electronic QMS, ERP
systems, and Microsoft Office applications Skills and Abilities:
Strong mechanical and electrical troubleshooting skills PLC and industrial controls diagnostic capability Knowledge of FDA & ISO
regulated manufacturing environments Strong problem solving and root cause analysis skills Ability to manage multiple priorities in a production environment Strong communication across engineering, quality, and operations teams Desired Knowledge, Skills, and Abilities:
Ability to adapt to changing priorities in a fast-paced environment Working knowledge of electronic QMS, ERP, & maintenance systems Knowledge of medical device manufacturing processes and FDA/ISO regulated environments Experience in manufacturing operations management or production support environments Knowledge of electrical systems and PLC controlled manufacturing equipment troubleshooting Knowledge of equipment validation processes and change control systems in regulated manufacturing environments Leadership and team management of maintenance personnel Experience with AutoCAD and/or SolidWorks Design Statistical Process Control, (SPC) and creating relative data from manufacturing processes Pay:
$75,000.00 - $95,000.00 per year Benefits:
Dental insurance Health insurance Paid time off Work Location:
In person
