Manufacturing Engineer

Becton Dickinson; Mebane (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

Waters is seeking a Manufacturing Engineer to support high-speed automated filling operations for medical diagnostic reagents in North Carolina. The role focuses on sustaining reliable production, improving process performance, and ensuring compliance with FDA and ISO requirements.

You will troubleshoot issues, drive continuous improvement across filling, capping, and labeling systems, and collaborate with cross-functional teams to optimize equipment and processes.

Qualifications

• Bachelor's degree in mechanical engineering.
• Minimum 5 years of manufacturing engineering experience.
• Experience with automated high-speed filling, capping, or packaging lines.
• Working knowledge of FDA, GMP, and ISO13485 requirements.
• Experience with process validation and structured problem-solving (RCA, DMAIC).
• Data analysis and graphical presentation skills using Excel or Minitab.

Responsibilities

• Provide day-to-day engineering support for automated filling lines, troubleshooting process variability and line downtime.
• Monitor and improve performance metrics (OEE, yield, downtime, scrap) using data-driven analysis.
• Lead root-cause investigations and plan/implement effective countermeasures.
• Identify and execute continuous improvement initiatives to increase throughput and equipment reliability.
• Collaborate with other engineers and Maintenance teams to perform root-cause analyses and develop solutions for production equipment.
• Support equipment upgrades, commissioning, and integration of new technologies.
• Utilize CAD software to design, modify and document mechanical components and layouts.
• Participate in validation activities (IQ/OQ/PQ) and maintain compliant SOPs and work instructions.
• Ensure adherence to FDA QMSR, ISO 13485, and GMP requirements.
• Support audits and change control processes.
• Partner with Reliability/Maintenance teams to improve preventive maintenance and spare parts management.
• Support capital projects with OEMs for troubleshooting and installations.

Skills

Data analysis

Problem solving

Cross-functional collaboration

Excel/Minitab

Education

Bachelor's degree in Mechanical Engineering

Tools

CAD software

PLC/HMI systems

Job description

As a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation, the opening is for a position with Waters. Waters is a global leader in life sciences, focused on regulated, high‑volume testing environments and innovative analytical technologies.

Job Description – Manufacturing Engineer

We are looking for a motivated Manufacturing Engineer to support high‑speed automated filling operations for medical diagnostic reagents. The role focuses on sustaining reliable production, improving process performance, and ensuring compliance with FDA and ISO requirements. Engineers partner cross‑functionally to troubleshoot issues, optimize equipment, and drive continuous improvement projects across filling, capping, and labeling systems.

Key Responsibilities

• Provide day‑to‑day engineering support for automated filling lines, including troubleshooting process variability, equipment downtime, and line inefficiencies.
• Monitor and improve performance metrics (OEE, yield, downtime, scrap) using data‑driven analysis and decisions.
• Lead root‑cause investigations and plan/implement effective countermeasures.
• Identify and execute continuous improvement initiatives to increase throughput and equipment reliability through data analysis.
• Collaborate with other engineers and Maintenance teams to perform root‑cause analyses and develop solutions for all aspects of production equipment.
• Support equipment upgrades, commissioning, and integration of new technologies.
• Utilize CAD software to design, modify, and document mechanical components, tooling, line layouts, and equipment improvements.
• Participate in validation activities (IQ/OQ/PQ) and maintain compliant documentation (SOPs, work instructions).
• Ensure adherence to FDA QMSR, ISO 13485, and GMP requirements.
• Support audits and change control processes.
• Partner with Reliability/Maintenance teams to improve preventive maintenance strategies, spare parts management, and equipment uptime.
• Support capital projects, working with OEMs for troubleshooting, upgrades, and installations.

Education & Experience Required

• Bachelor’s degree in mechanical engineering.
• Minimum 5 years of manufacturing engineering experience.
• Experience with automated high‑speed filling, capping, or packaging lines.
• Working knowledge of FDA, GMP, and ISO13485 requirements.
• Experience with process validation and structured problem‑solving (RCA, DMAIC).
• Data analysis and graphical presentation skills using Excel or similar software such as Minitab.

Preferred Qualifications

• Minimum 5 years of manufacturing engineering experience in the medical device, pharma, or diagnostics industry.
• Familiarity with PLC/HMI systems and industrial automation.

Becton, Dickinson and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.