Device Development Engineer III – Hybrid (Boston)

Alexion Pharma Spain S.L.; Boston (MA); Hybrid; USD 102,000 - 152,000; Full time

Benefits offered by this job

Health insurance

Paid time off

Retirement plan

Job summary

Alexion is seeking an Engineer III for device development in Boston, MA (hybrid 3x/week) or New Haven, CT. The role supports design and development of drug-delivery devices within the Development function and assists in technology transfer.

You will collaborate with device partners, test hardware, verify designs, and ensure QA/regulatory compliance. A biomedical/engineering degree with 4–6 years in medical device development is preferred.

Qualifications

• Bachelor’s degree in Engineering (Biomedical, Chemical, Mechanical, or Electrical) with design controls experience.
• Knowledge of primary containers and drug delivery.
• Experience with validating processes IQ/OQ/PQ and regulatory expectations.

Responsibilities

• Support device development activities with engineering teams for drug-delivery devices and combination products.
• Collaborate with device partners on design, verification, and hardware development.
• Perform characterization of device function, manufacturability, and testing on bench models.
• Ensure alignment with QA and regulatory requirements (FDA QSR 21 CFR Part 4; ISO13485).

Skills

Design controls

Medical device knowledge

Cross-functional collaboration

Problem solving

Verbal written communication

Education

Bachelor’s degree in Engineering

Job description

Alexion is seeking an Engineer III for device development in Boston, MA (hybrid 3x/week) or New Haven, CT. The role supports design and development of drug-delivery devices within the Development function and assists in technology transfer.

You will collaborate with device partners, test hardware, verify designs, and ensure QA/regulatory compliance. A biomedical/engineering degree with 4–6 years in medical device development is preferred.