Senior Systems Engineer - Medical Devices & Biologics

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

Benefits offered by this job

Health and welfare plans

Retirement and Savings Plan

Stock-based long-term incentives

Paid time off

Job summary

Amgen in Cambridge, MA seeks a Senior Systems Engineer to lead cross-functional development activities for a combination product program, ensuring system requirements, risk management, and lifecycle changes are properly implemented.

You will collaborate across engineering, quality, regulatory, supply chain, packaging, labeling, and product teams to maintain traceability and verification plans, while mentoring junior engineers and driving continuous improvement.

Qualifications

• Experience in systems engineering for combination products.
• Ability to lead cross-functional engineering teams.
• Strong knowledge of design controls, risk management, and traceability.
• Experience performing system-level impact assessments.
• Ability to translate user needs into system requirements.
• Mentor junior engineers.

Responsibilities

• Lead development activities within cross-functional program teams.
• Capture user needs and translate into system requirements.
• Own systems engineering deliverables and manage risk retirement.
• Collaborate with engineering, quality, regulatory, supply chain.
• Maintain system requirements, specifications, and traceability.
• Drive lifecycle change control and verification planning.
• Support design transfer and implementation of changes.
• Mentor junior engineers.

Skills

Systems engineering

Cross-functional coordination

Requirements management

Traceability

Design controls

Risk management

Verification & validation

Regulatory knowledge

Communication skills

Leadership

Mentoring

Education

Doctorate degree

Masters degree + 2 years experience

Bachelors degree + 4 years experience

Associates degree + 8 years experience

High school diploma / GED + 10 years experience

Job description

Amgen in Cambridge, MA seeks a Senior Systems Engineer to lead cross-functional development activities for a combination product program, ensuring system requirements, risk management, and lifecycle changes are properly implemented.

You will collaborate across engineering, quality, regulatory, supply chain, packaging, labeling, and product teams to maintain traceability and verification plans, while mentoring junior engineers and driving continuous improvement.