Impactful Device Development Engineer III

AstraZeneca plc; Boston (MA); Hybrid; USD 102,000 - 152,000; Full time

Benefits offered by this job

Short-term incentives

Equity-based awards

Health insurance

Retirement plan

Paid time off

Job summary

Alexion is seeking an Engineer III for device development of our products. The role focuses on technical design, development of drug-delivery devices, and transfer activities, with a mix of in-office and flexible work arrangements in Boston and New Haven.

The candidate will support device development, collaborate with partners, and ensure compliance with QA and regulatory standards. Requires engineering degree and experience with design controls.

Qualifications

• Bachelor’s degree in Engineering
• Experience in design controls activities
• Knowledge of primary containers and drug delivery
• Understanding of mold, fixture design and validation IQ/OQ/PQ
• Experience collaborating with medical device vendors and tooling
• Regulatory/compliance knowledge: FDA QSR 21 CFR Part 4 and ISO13485

Responsibilities

• Support device development with the engineering team to develop and bring to market a combination product.
• Collaborate with device partners on design/hardware for drug delivery devices and test equipment.
• Develop and assess innovative container closure systems.
• Characterize device function, manufacturability, and assembly using CAE and physical testing.
• Test mechanical/electromechanical systems on bench models and production units.
• Liaise with vendors and toolmakers.
• Communicate across departments and external suppliers.
• Align with QA and regulatory requirements.

Skills

Device development

Design controls

Regulatory knowledge

Mold/fixture design

QA processes

Cross-functional collaboration

Communication skills

Education

Bachelor's degree in Engineering

Job description

Alexion is seeking an Engineer III for device development of our products. The role focuses on technical design, development of drug-delivery devices, and transfer activities, with a mix of in-office and flexible work arrangements in Boston and New Haven.

The candidate will support device development, collaborate with partners, and ensure compliance with QA and regulatory standards. Requires engineering degree and experience with design controls.