We are seeking a Manufacturing Engineer to develop, optimize, and implement advanced manufacturing processes that improve efficiency, quality, and cost-effectiveness. This role will be pivotal in driving automation, process improvement, and Lean Manufacturing initiatives in a regulated medical device environment and will be located onsite at our Northampton, PA facility.

Key Responsibilities

Process & Equipment Engineering

  • Design, develop, and implement assembly and test fixtures, jigs, and automation solutions to enhance production efficiency.
  • Analyze manufacturing workflows, material flow, and bottlenecks to optimize operations.
  • Assist in the validation and qualification of new processes and equipment (IQ, OQ, PQ).

Automation & Industry 4.0 Integration

  • Lead initiatives in PLC programming, robotics, and machine automation to improve production consistency.
  • Work with IoT-enabled devices and real-time monitoring for smart manufacturing applications.
  • Implement automated flow and pressure measurement devices to enhance quality control.

Quality & Compliance

  • Ensure GMP, FDA QSR, and ISO 13485 compliance in all manufacturing processes.
  • Perform root cause analysis and corrective actions (CAPA) to address quality deviations.
  • Perform risk management to proactively identify risks.

Perform other duties as assigned.

Qualifications

Education & Experience

  • Bachelor’s degree in manufacturing engineering, mechanical engineering, industrial engineering, or a related field.
  • 3-5 years of experience in manufacturing engineering, preferably in a regulated industry (medical devices, aerospace, automotive, etc.).
  • Hands-on experience in process automation, fixture design, and continuous improvement methodologies.

Technical Skills

  • Proficiency in SolidWorks, AutoCAD, or other 3D CAD software.
  • Strong knowledge of PLC programming, electrical, and pneumatics.
  • Experience with robotics and automation systems.
  • Strong problem-solving skills and ability to lead process improvement projects.
  • Basic machining knowledge using milling machines, lathes, and grinders.

To apply to this position, fill out our employee application.