Senior NPI Manufacturing Engineer — Lean Leader in Medical Devices

Exalta Group; Shimer (PA); On-site; USD 90,000 - 120,000; Full time

Job summary

Exalta Group in Bethlehem, PA is seeking an NPI Manufacturing Engineer to develop, optimize, and document manufacturing processes for medical devices. You will collaborate with Quality, Production, and Engineering to ensure product consistency and regulatory compliance.

The role requires Lean/Six Sigma expertise, SolidWorks CAD, ERP familiarity, and hands-on experience with process improvement, CAPA investigations, and GMP/QMS. Prolonged standing and lifting 40 lbs are expected.

Qualifications

• 5 years of experience in manufacturing engineering in the medical device industry preferred.
• Bachelor’s degree in Manufacturing, Industrial or Mechanical Engineering or related field.
• Strong knowledge of GMP, ISO 13485 and quality systems in medical device manufacturing.

Responsibilities

• Lead production-support efforts with management to ensure efficient and effective operations.
• Conduct time studies, process flow analyses, and tool life studies to optimize efficiency and labor planning.
• Lead Lean and Six Sigma improvements to enhance safety, quality, productivity, and costs.
• Drive continuous improvement initiatives, including kaizen events and process optimization.
• Design and implement processes, fixtures and tooling to support and optimize manufacturing operations and ensure quality alignment.
• Collaborate across departments and sites to standardize processes and share best practices.
• Provide expert technical support for troubleshooting, root cause analyses, NC investigations and CAPA processes.
• Create and update SWIs, SOPs, BOOs, BOMs, and CCs, reflecting evolving production needs.
• Support training programs and on-the-floor guidance.
• Ensure adherence to Tyber Medical Safety, OSHA, cGMP, GDP and QMS requirements.
• Other duties as assigned.

Skills

Lean manufacturing

Six Sigma

Root cause analysis

MS Office

CAPA investigations

Education

Bachelor’s degree in Manufacturing Engineering

5 years of experience in manufacturing engineering (medical device)

Tools

SolidWorks CAD

ERP systems

3D Printing

Job description

Exalta Group in Bethlehem, PA is seeking an NPI Manufacturing Engineer to develop, optimize, and document manufacturing processes for medical devices. You will collaborate with Quality, Production, and Engineering to ensure product consistency and regulatory compliance.

The role requires Lean/Six Sigma expertise, SolidWorks CAD, ERP familiarity, and hands-on experience with process improvement, CAPA investigations, and GMP/QMS. Prolonged standing and lifting 40 lbs are expected.