Senior Systems Engineer, Medical Devices & Biologics

Amgen Inc.; Cambridge (MA); On-site; USD 115,000 - 156,000; Full time

Benefits offered by this job

Retirement plan

Stock-based incentives

Generous time-off

Flexible work models

Job summary

Amgen Inc. in Cambridge, MA is seeking a Senior Systems Engineer to lead cross-functional lifecycle activities for complex combination product systems.

You will own system requirements, traceability, verification plans and risk management, coordinating with engineering, quality, regulatory and operations to ensure compliant, high-quality changes. The role emphasizes strong communication, leadership of design controls, and early planning for verification and validation.

Qualifications

• Doctorate or equivalent required.
• Experience in systems engineering and product development.
• Strong knowledge of design controls, requirements management, traceability and validation.

Responsibilities

• Lead systems engineering assessment, planning and cross-functional coordination of lifecycle change controls.
• Perform system-level impact assessments for proposed changes and verify/document changes.
• Maintain system requirements, specifications and traceability as systems evolve.
• Drive continuous improvement in lifecycle management processes and verification approaches.
• Mentor junior engineers and communicate technical assessments to stakeholders.

Skills

Systems engineering

Requirements management

Traceability

Design controls

Risk management

Cross-functional coordination

Verification & validation

Lean Six Sigma

Technical communication

Education

Doctorate degree

Master's degree + 2 years

Bachelor's degree + 4 years

Associate's degree + 8 years

High school diploma / GED + 10 years

Job description

Amgen Inc. in Cambridge, MA is seeking a Senior Systems Engineer to lead cross-functional lifecycle activities for complex combination product systems.

You will own system requirements, traceability, verification plans and risk management, coordinating with engineering, quality, regulatory and operations to ensure compliant, high-quality changes. The role emphasizes strong communication, leadership of design controls, and early planning for verification and validation.