Senior Manufacturing Engineer - Medical Devices, Lean & CAPA

Zing Recruiting; Bethlehem (Northampton County); On-site; USD 105,000 - 135,000; Full time

Job summary

Zing Recruiting is seeking a senior Manufacturing Engineer IV to own manufacturing processes and documentation in Bethlehem, PA. The role emphasizes FDA-regulated medical device experience, process ownership, and collaboration with Quality, Production, Engineering, and Product Development.

Responsibilities include leading improvements, managing changes, developing SOPs, and supporting CI initiatives while traveling occasionally for FAT and supplier activities.

Qualifications

• Bachelor's degree in Mechanical/Manufacturing/Materials Engineering or related field.
• 5+ years in Manufacturing Engineering; 8+ years preferred.
• Experience in FDA-regulated manufacturing environments.
• Proven ability to write and maintain SOPs and technical docs.
• Strong problem-solving, communication, and project management skills.

Responsibilities

• Lead manufacturing process improvements and CI initiatives.
• Manage engineering change controls and related documentation.
• Develop and maintain SOPs, work instructions, procedures, and other docs.
• Support production with troubleshooting, root cause analysis, and optimization.
• Lead capital equipment and semi-automated projects.
• Collaborate with Product Development on new product introductions.
• Support CAPA, quality, safety, and cost-reduction efforts.
• Drive Lean Manufacturing and continuous improvement projects.
• Occasionally travel for FAT and supplier interactions.

Skills

Manufacturing process improvements

Root cause analysis

CAPA

Lean Manufacturing

Project management

Technical documentation

Troubleshooting

Education

Bachelor's degree in Mechanical Engineering

Tools

SolidWorks

CNC milling

CNC lathe

ISO 13485 experience

Job description

Zing Recruiting is seeking a senior Manufacturing Engineer IV to own manufacturing processes and documentation in Bethlehem, PA. The role emphasizes FDA-regulated medical device experience, process ownership, and collaboration with Quality, Production, Engineering, and Product Development.

Responsibilities include leading improvements, managing changes, developing SOPs, and supporting CI initiatives while traveling occasionally for FAT and supplier activities.