Senior Device Development Engineer II (Hybrid, Cambridge)

Biogen; Cambridge (MA); Hybrid; USD 120,000 - 160,000; Full time

Job summary

Biogen in Cambridge, MA seeks a Senior Engineer II in the Device Development group to advance design, development, and lifecycle management of patient-centric drug delivery devices and combination products.

The role focuses on new product development and sustaining engineering, collaborating across multiple internal teams and external partners to align device strategy with program needs.

Qualifications

• Bachelor's degree in biomedical, electrical, or mechanical engineering with 6+ years in device/combination product development.
• 3+ years experience with drug delivery and combination products (autoinjectors, pre-filled syringes, wearable injectors).
• Experience with medical device standards and regulations (ISO 13485, MDR/IVDR) would be advantageous.

Responsibilities

• Develop and manage design history file content for combination products.
• Translate user interactions and clinical use into risk assessments and verification plans.
• Lead technical issue resolution across cross-functional teams.

Skills

Device development

Combination product development

Drug delivery systems

Education

Bachelor's degree in biomedical, electrical, or mechanical engineering

Tools

ISO 13485

Regulatory standards (FDA ISO)

Job description

Biogen in Cambridge, MA seeks a Senior Engineer II in the Device Development group to advance design, development, and lifecycle management of patient-centric drug delivery devices and combination products.

The role focuses on new product development and sustaining engineering, collaborating across multiple internal teams and external partners to align device strategy with program needs.