Senior Device Assembly Engineer - Remote/Hybrid Lead

Amgen SA; New Albany (OH); Hybrid; USD 120,000 - 170,000; Full time

Benefits offered by this job

Total Rewards Plan

Remote/hybrid work arrangements

Job summary

Amgen is seeking a Senior Device Assembly Engineer to lead technical development and lifecycle management for ConfiPen device assembly platforms throughout the product lifecycle.

You will collaborate across Device Engineering, manufacturing, Quality, Regulatory, and external partners to drive design changes, investigations, and process optimization, ensuring safety, quality, and regulatory compliance.

Qualifications

• Doctorate or Master’s with engineering/operations experience (depending on path)
• Bachelor’s degree in mechanical/biomedical/related field required or 8+ years equivalent
• Experience with Design Control, DFMEA/PFMEA, and regulatory knowledge (21 CFR 820)

Responsibilities

• Lead design changes and lifecycle management for ConfiPen devices.
• Provide technical leadership across device engineering, manufacturing, and quality teams.
• Conduct DOE studies to optimize assembly processes and establish robust windows.
• Coordinate with suppliers and process development for tech transfer and scale-up.
• Own verification/validation strategies and engineering documentation.

Skills

DOE (Design of Experiments)

Statistical analysis

Device assembly knowledge

Cross-functional leadership

Education

Bachelor's degree in engineering

Master's or Doctorate in engineering

Tools

SolidWorks

CAD

Minitab/JMP

Quality systems

Job description

Amgen is seeking a Senior Device Assembly Engineer to lead technical development and lifecycle management for ConfiPen device assembly platforms throughout the product lifecycle.

You will collaborate across Device Engineering, manufacturing, Quality, Regulatory, and external partners to drive design changes, investigations, and process optimization, ensuring safety, quality, and regulatory compliance.