Senior Systems Engineer – Medical Device Lifecycle Leader

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

Benefits offered by this job

Total Rewards Plan

Retirement Plan

Medical coverage

Dental & Vision

Disability Insurance

Flexible Spending Accounts

Stock-based incentives

Bonus program

Paid time off

Flexible work model

Job summary

Amgen is seeking a Senior Systems Engineer to lead cross-functional development for a combination product program. You will translate user needs into system requirements, maintain traceability, and drive risk assessment and verification activities across engineering, quality, regulatory, supply chain, packaging, labeling, and product teams.

You will ensure lifecycle changes are documented and implemented, while mentoring junior engineers.

Qualifications

• Doctorate or Master’s degree with 2+ years of experience, or Bachelor’s with 4+ years.
• Preferred: formal Systems Engineering training/certification.
• Experience in medical devices or combination products.

Responsibilities

• Lead cross-functional systems engineering activities for a combination product program.
• Create system requirements, architecture, and verification plans.
• Manage lifecycle changes and design controls across functions.
• Coordinate risk management and verification evidence.
• Mentor junior engineers and support design transfer.
• Communicate assessments and recommendations to leadership.

Skills

Cross-functional leadership

Systems engineering

Requirements management

Traceability

Risk assessment

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma

Tools

None

Job description

Amgen is seeking a Senior Systems Engineer to lead cross-functional development for a combination product program. You will translate user needs into system requirements, maintain traceability, and drive risk assessment and verification activities across engineering, quality, regulatory, supply chain, packaging, labeling, and product teams.

You will ensure lifecycle changes are documented and implemented, while mentoring junior engineers.