Senior Device Development Engineer

Biogen, Inc.; Cambridge (MA); Hybrid; USD 117,000 - 157,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Life Insurance

Fitness & Wellness programs

Disability Insurance

Paid vacation and year-end shutdown

Company holidays and personal days

Sick time

Maternity and Parental Leave

401(k) with company match

Employee Stock Purchase Plan

Tuition reimbursement

Employee Resource Groups

Job summary

Biogen in Cambridge, MA is seeking a Senior Engineer II in the Device Development group to drive design, development, and lifecycle management of patient-centric drug delivery devices and combination products. This role supports both new product development and sustaining engineering.

You will collaborate across Quality, Regulatory, Manufacturing, and other teams, applying rigorous engineering analysis, leading verification, validation, and risk assessments, and contributing to device controls

Qualifications

• Bachelor's degree in biomedical, electrical, or mechanical engineering with 6+ years in device/combination product development
• 3+ years with drug delivery/combination products (autoinjectors, pre-filled syringes, wearable injectors, etc.)
• Experience with ISO 13485, ISO 14971, 21 CFR Part 4, 510(k), PMA, MDR
• Experience with new product introduction including design, analysis, prototyping, testing

Responsibilities

• Develop and maintain Design History File content for combination products
• Translate user interactions and product performance into risk assessments with traceability to requirements
• Lead technical issue resolution and root cause analysis across cross-functional teams
• Support design changes, lifecycle management, risk analyses, and change control activities
• Maintain Device Master Record content and supplier documentation for devices
• Manage device constituent part development and supplier collaborations
• Engage with external partners onsite and virtually
• Support innovation projects with technology landscaping and prototyping
• Oversee contract lab verifications and data analysis
• Contribute to project planning and regulatory filings with third parties

Skills

Collaboration across functions

Problem solving

Technical judgment

Effective communication

Education

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

Advanced degree in biomedical, electrical, or mechanical engineering

Tools

Design of Experiments

Design for Six Sigma

Design for Manufacturing

First-principles modeling

FEA

Regulatory standards knowledge

Job description

Biogen in Cambridge, MA is seeking a Senior Engineer II in the Device Development group to drive design, development, and lifecycle management of patient-centric drug delivery devices and combination products. This role supports both new product development and sustaining engineering.

You will collaborate across Quality, Regulatory, Manufacturing, and other teams, applying rigorous engineering analysis, leading verification, validation, and risk assessments, and contributing to device controls