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 Med Tech 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.

• 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.

• 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.

• 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.

• Provide technical leadership and support for daily manufacturing operations.

• Partner with Production, Maintenance, and Quality personnel to rapidly address production issues and minimize…