Senior Process Engineer

Senior Process Engineer

The Senior Process Engineer supports the transfer of ultrasound transducer programs from R&D into regulated production, ensuring manufacturing processes meet quality, regulatory, cost, and delivery requirements. Serves as a technical partner to R&D, Quality, Operations, and Supply Chain during product introduction, process qualification, and issue resolution. Leads continuous improvement initiatives to improve process capability, yield, and operational efficiency. Owns and improves manufacturing documentation, work instructions, and operator training to enable consistent, repeatable production.

Demonstrates working knowledge of materials used in ultrasound transducer manufacturing, including ceramics, polymers, epoxies, adhesives, and solvents, with consideration for usability, environmental impact, and long-term reliability. Applies fixture design principles and understands how fixture characteristics influence downstream product performance and measurement outcomes. On-site position at the State College, PA manufacturing site.

At our State College site, teams design, manufacture, and service diagnostic medical ultrasound transducers (probes) used across a wide range of clinical applications including surgery, urology, cardiology, and radiology. As a high-mix, low-volume, regulated manufacturing environment, the site combines advanced engineering, precision manufacturing, and lifecycle support to deliver critical imaging technology that enables clinicians to make real-time decisions in patient care.

• Provide manufacturing engineering support for the transfer of processes from R&D into full production.
• Apply and improve standard manufacturing approaches to ensure robust, capable production processes.
• Support quality and regulatory compliance during product introduction, including coordination of process and equipment qualification activities.
• Serve as a technical liaison with Quality to ensure requirements are met and documentation is complete and compliant.
• Interface with Purchasing and suppliers to define and clarify incoming material technical requirements.
• Develop, evaluate, and improve manufacturing methods to reduce lead time and increase yield.
• Prepare technical analyses and project status updates for leadership review.
• Analyze workforce utilization, space requirements, and workflow, and support equipment and workspace layout for optimal efficiency.

• Bachelor's degree in an Engineering or Science discipline from an accredited college or university
• Minimum 5 years' experience in a manufacturing environment

• Experience in a FDA, ISO
  13485, or other highly regulated environment required.
• Master's degree in an Engineering or Science discipline from an accredited institution
• Working knowledge of ERP systems (e.g., Visual, Oracle, SAP) and electronic Device History Record (eDHR) systems
• Experience in medical device manufacturing, preferably ultrasound transducers
• Experience with process risk evaluation and mitigation techniques, including pFMEA
• Proficiency in data analysis, including statistical methods and visualization
• Demonstrated project management skills
• Demonstrates energy, ownership, and enthusiasm in day-to-day work