Senior Device Assembly Lead — Drug-Device Systems (Remote)

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

Benefits offered by this job

Flex work options

Job summary

Amgen is seeking a Senior Device Assembly Engineer to lead lifecycle management of ConfiPen device assemblies. You will drive DOE, design verification/validation, and cross‑functional collaboration across Manufacturing, Quality, Regulatory, and external partners.

Responsibilities include leading engineering investigations, supporting technology transfer, and mentoring junior engineers to ensure robust, compliant manufacturing processes.

Qualifications

• Knowledge of 21 CFR 820/Quality System Regulation and Design Control processes.
• Experience designing, executing, and analyzing DOE studies.
• Experience with laboratory studies evaluating devices, processes, and equipment.
• Experience supporting automated assembly equipment troubleshooting.
• Ability to interpret force‑displacement monitoring data for process improvement.

Responsibilities

• Lead design change and lifecycle management for commercial ConfiPen devices.
• Provide technical leadership across device design, assembly, and testing.
• Conduct DOE, develop lab methods, and translate results into actions.
• Support technology transfer, scale‑up, and product launches.
• Own deviations, CAPAs, DFMEA/PFMEA, and regulatory technical reports.
• Collaborate with suppliers and cross‑functional teams globally.

Skills

Cross-functional leadership

Project management

Strong communication

Statistical methods

Technical writing

Mentoring

Problem solving

Regulatory understanding

Education

Doctorate degree

Master's degree + 2 years engineering/operations

Bachelor's degree + 4 years engineering/operations

Associate's degree + 8 years engineering/operations

High school diploma + 8 years engineering/operations

Tools

SolidWorks

CAD

Minitab

JMP

Job description

Amgen is seeking a Senior Device Assembly Engineer to lead lifecycle management of ConfiPen device assemblies. You will drive DOE, design verification/validation, and cross‑functional collaboration across Manufacturing, Quality, Regulatory, and external partners.

Responsibilities include leading engineering investigations, supporting technology transfer, and mentoring junior engineers to ensure robust, compliant manufacturing processes.