Engineer III, Device Development

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

Engineer III, Device Development

Location: Boston, MA (hybrid 3x a week) or New Haven, CT

When we put unexpected teams in the same room, we unleash bold thinking with the power to encourage life-changing medicines. In-person working gives us the platform to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our outstanding and ambitious world.

Introduction to the role

This position will serve the role of Engineer III for device development of Alexion products including continuous product improvement within the Development function of Alexion. The candidate will support technical design and development activities for device and combination products and assist the technology transfer.

What you’ll do:

• Support device development activities with the device engineering team to development and bring to market combination product.
• Support work with device partners in the creation, evolution, optimization and verification of designs and hardware for drug delivery devices, their associated test equipment precision measurement systems, and other such equipment.
• Help assess and develop innovative container closure systems.
• Conduct characterization for device function, assembly, manufacturability, etc. using both CAE and traditional engineering techniques.
• Test mechanical or electromechanical systems on bench top models or production representative units, during design development and verification.
• Liaise with third parties such as specialist manufacturers and toolmakers.
• Communicate effectively, both verbally and in writing, internally across departments and with external suppliers.
• Align with the Company’s quality assurance requirements as well as applicable regulatory requirements.

Requirements:

• Bachelor’s degree in Engineering (Biomedical, Chemical, Mechanical, or Electrical Engineering)
• Experience in design control activities.
• Knowledge of primary containers and drug delivery.
• Understanding of mold, fixture design and build as well as application of validation processes (IQ/OQ/PQ).
• Experience collaborating with the medical device vendor and tooling company.
• Knowledge of the regulatory and compliance requirements of device design controls and combination products (i.e. FDA QSR 21 CFR Part 4 and 820/ISO13485 quality system requirements).
• The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
• 4-6 year experience in medical device development preferred.
• Experience with injector-based combination product preferred.

At Alexion, you will find a collaborative culture that encourages innovation and a diverse environment where your contributions are valued. You will have the opportunity to be at the forefront of rare disease research and make a meaningful difference in patients' lives.

The annual base pay for this position ranges from 101,643.20 - 152,464.80 USD. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

Date Posted

21-Oct-2026

Closing Date

03-Nov-2026

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.