Senior Process Engineer, Combo Products & Medical Devices

Amgen SA; New Albany (OH); Hybrid; USD 120,000 - 180,000; Full time

Job summary

Amgen Ohio is seeking a Sr. Process Development Engineer with expertise in combination products and medical device assembly. You will lead device engineering, process development, and technology transfer to commercial manufacturing.

Join a cross‑functional team focused on compliant, scalable manufacturing. You will mentor others, optimize processes using DOE/SPC, and ensure robust product performance across the lifecycle.

Qualifications

• Experience in GMP regulated environments and device engineering.
• Ability to lead development, technology transfer, and manufacturing support.
• Strong knowledge of regulatory submissions and DHF documentation.

Responsibilities

• Lead SME for combination products and device assembly technologies.
• Drive automated assembly equipment development and transfer to production.
• Support product commercialization and design transfer.
• Create engineering studies, protocols, and reports.
• Analyze data to improve process capability and robustness.
• Provide technical leadership across cross‑functional teams.

Skills

Device engineering

Process development

GMP knowledge

Regulatory compliance

DOE/SPC

Education

Bachelor's degree in Engineering

Master’s degree

Doctorate degree

Associate’s degree

High school diploma

Tools

SolidWorks

CAD tooling

Instrumentation

Job description

Amgen Ohio is seeking a Sr. Process Development Engineer with expertise in combination products and medical device assembly. You will lead device engineering, process development, and technology transfer to commercial manufacturing.

Join a cross‑functional team focused on compliant, scalable manufacturing. You will mentor others, optimize processes using DOE/SPC, and ensure robust product performance across the lifecycle.