Senior Systems Engineer, Medical Devices & Lifecycle

Amgen SA; Cambridge (MA); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Retirement and Savings Plan

Medical, Dental, Vision coverage

Disability insurance

Flexible spending accounts

Discretionary bonus program

Stock-based incentives

Paid time off

Flexible work models

Job summary

Amgen seeks a Senior Systems Engineer to lead cross-functional development activities for a cross-disciplinary program. You will own system requirements, traceability, verification planning, and risk management, while coordinating lifecycle changes and ensuring high product quality.

The role requires extensive collaboration across engineering, quality, regulatory, and operations, with emphasis on leadership, mentorship, and adherence to design controls within a regulated environment.

Qualifications

• Basic Qualifications: Doctorate or Master’s with 2 years experience or Bachelor’s with 4 years or Associate’s with 8 years or High school with 10 years.
• Preferred Qualifications: 6+ years systems engineering experience, 5+ years in medical device/product development, formal Systems Engineering training, lean six sigma competency, strong cross-functional collaboration, lifecycle management in regulated enviroments.

Responsibilities

• Lead systems engineering assessment, planning, and cross-functional coordination of lifecycle change controls.
• Perform system-level impact assessments for proposed changes affecting requirements, design, risk, traceability, and verification.
• Maintain system requirements, specifications, and traceability as products evolve.
• Coordinate re-verification when lifecycle changes affect verified state.
• Mentor junior engineers and communicate assessments to stakeholders.
• Drive continuous improvement in lifecycle management and verification practices.

Skills

Leadership

Cross-functional coordination

Requirements development

Verification planning

Risk management

Communication

Mentoring

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma/GED

Tools

Systems Engineering training

Lean Six Sigma

Job description

Amgen seeks a Senior Systems Engineer to lead cross-functional development activities for a cross-disciplinary program. You will own system requirements, traceability, verification planning, and risk management, while coordinating lifecycle changes and ensuring high product quality.

The role requires extensive collaboration across engineering, quality, regulatory, and operations, with emphasis on leadership, mentorship, and adherence to design controls within a regulated environment.