Senior Manufacturing Process Engineer

Senior Manufacturing Process Engineer

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

The Senior Manufacturing Process Engineer is responsible for leading manufacturing process improvements, automation initiatives, capital projects, and operational excellence programs within a regulated medical device manufacturing environment. Reporting to the Senior Technical Leader, this position drives strategic Continuous Improvement and Cost-to-Win initiatives through data-driven analysis of Overall Equipment Effectiveness (OEE), waste, quality losses, and equipment performance. This role serves as a technical leader focused on improving production capacity, product quality, regulatory compliance, equipment reliability, and manufacturing costs while ensuring adherence to FDA Quality System Regulations (QSR), ISO 13485 requirements, and internal quality standards. The Senior Manufacturing Process Engineer collaborates closely with Operations, Quality, Maintenance, Validation, Regulatory Affairs, Supply Chain, and R&D to deliver sustainable business results and support the manufacture of safe and effective medical devices.

Essential Responsibilities:

Manufacturing Excellence & Lean Operations

• Lead Lean Manufacturing and Continuous Improvement initiatives focused on eliminating waste, improving productivity, reducing cost, and enhancing product quality.
• Analyze manufacturing performance data to identify opportunities associated with OEE losses, scrap generation, downtime, quality defects, and process variation.
• Lead Cost-to-Win programs that deliver measurable improvements in manufacturing efficiency, material utilization, labor productivity, and operational costs.
• Utilize Lean, Six Sigma, and root cause analysis methodologies to resolve chronic manufacturing challenges and improve process capability.
• Facilitate Kaizen events, and continuous improvement projects across manufacturing operations.

Process Engineering & Equipment Optimization

• Design, troubleshoot, validate, and optimize automated assembly and manufacturing equipment used in medical device production.
• Improve equipment reliability, process capability, and throughput while maintaining compliance with product specifications and quality system requirements.
• Lead investigations and corrective actions related to equipment performance, process deviations, and quality events.
• Support continuous improvement of high-speed automated assembly systems, including synchronous and asynchronous platforms, servo-controlled equipment, pneumatic systems, and cam-driven equipment.
• Develop and implement process controls that reduce variability and improve product quality.

Capital Projects & Capacity Expansion

• Lead capital equipment projects from concept, justification, and procurement through installation, validation, commissioning, and production release.
• Prepare capital appropriation requests and business cases that demonstrate operational and financial benefits.
• Manage project schedules, budgets, contractors, vendors, and internal resources to ensure successful execution.
• Support capacity expansion initiatives to meet growing customer demand and business objectives.

Manufacturing Support & Technical Leadership

• Provide technical leadership and support for daily manufacturing operations.
• Partner with Production, Maintenance, and Quality personnel to rapidly address production issues and minimize operational disruptions.
• Direct the activities of technicians, machinists, maintenance personnel, contractors, and vendors during equipment modifications and installations.
• Train operators, technicians, and support personnel on new equipment, processes, and procedures.

Required Qualifications

• Bachelor's Degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or related Engineering discipline.
• Minimum of 3 years of manufacturing engineering experience in a regulated manufacturing environment.
• Experience supporting high-speed automated manufacturing and assembly equipment.
• Strong understanding of:
• OEE performance metrics
• Lean Manufacturing principles
• Root cause analysis methodologies
• Statistical process control
• Process capability and variation reduction
• Experience managing multiple projects and priorities simultaneously.
• Strong mechanical troubleshooting and problem-solving skills.

Preferred Qualifications

• Experience in medical device, pharmaceutical, biotechnology, or highly regulated manufacturing environments.
• Experience working within FDA-regulated and ISO 13485-certified facilities.
• Lean Manufacturing certification.
• Six Sigma Green Belt or Black Belt certification.
• Experience with validation protocols (IQ/OQ/PQ), CAPA systems, and change management processes.
• Capital project management experience involving automated manufacturing systems.

Key Performance Areas

• OEE Improvement and Loss Elimination
• Cost-to-Win Savings Achievement
• Scrap and Waste Reduction
• Equipment Reliability and Uptime
• Manufacturing Capacity Expansion
• Quality Improvement and Defect Reduction
• Regulatory and Validation Compliance
• Capital Project Execution
• Lean Manufacturing Deployment
• Continuous Improvement Leadership

Success Measures

• The Senior Manufacturing Process Engineer will be expected to deliver measurable improvements in:
• Equipment availability, performance, and quality metrics.
• Manufacturing cost reduction and productivity gains.
• Scrap, rework, and material waste reduction.
• Process capability and product quality.
• Capital project execution and return on investment.
• Compliance with FDA, ISO 13485, and internal quality system requirements.

Work Environment:

• BD is a smoke-free campus. Smoking and the use of electronic smoking devices, marijuana, or tobacco products are not allowed on BD property, grounds or in the parking areas. We appreciate your cooperation in adhering to this policy.
• False eyelashes, press-on fingernails, and Jewelry is not allowed on the production floor including dermals. Any associate wearing dermals will be required to cover them while working on the production floor.
• Shoes are required to be Steel Toe and non-slip for all associates while on the production floor for safety purposes.

Primary Work Location: USA SC - Sumter