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
- Lead and manage the maintenance team, providing daily direction, prioritization, and technical oversight to ensure timely resolution of mechanical, electrical, and controls related equipment issues across manufacturing operation
- Oversee vendor relationships and external service providers for complex repairs, equipment upgrades and specialized maintenance activities when internal capabilities are exceeded
- Develop, implement, and maintain 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
- Lead or support change control activities, including documentation updates, risk assessments, and implementation planning
- Analyze production data and key performance indicators to identify trends, risks, and improvement opportunities
- Develop and maintain standard operating procedures, work instructions, and engineering documentation
- Provide technical leadership and mentorship to junior engineers and cross functional team members
- Manage capital projects including scope definition, budgeting, installation, and commissioning of new equipment or facility upgrades
Education and Experience:
- 7 to 12 years manufacturing engineering or maintenance engineering experience
- Hands on troubleshooting and repair of manufacturing equipment required
- Experience managing maintenance teams required
- Strong computer skills required, with ability to quickly learn and utilize electronic QMS, ERP systems, and Microsoft Office applications
- Experience in FDA and ISO regulated manufacturing environment preferred
- Electrical and PLC troubleshooting experience preferred
- Experience with equipment validation and change control preferred
- Experience with AutoCAD and/or SolidWorks Design preferred
Skills and Abilities:
- Strong mechanical and electrical troubleshooting skills
- PLC and industrial controls diagnostic capability
- Leadership and team management of maintenance personnel
- 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 regulated environments
- Experience in manufacturing operations management or production support environments
- Statistical Process Control, (SPC) and creative relative data from manufacturing processes
Pay: $95,000.00 - $130,000.00 per year
Benefits:
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Work Location: In person
