Engineer III, Device Development

AstraZeneca•Boston, MA

5d•$101,643 - $152,465•Hybrid

About The Position

This position serves as an Engineer III for device development of Alexion products, including continuous product improvement within the Development function. The candidate supports technical design and development activities for device and combination products and assists with technology transfer. The role supports device development with the device engineering team to develop and bring combination products to market. It involves working with device partners on the creation, evolution, optimization, and verification of designs and hardware for drug-delivery devices, associated test equipment, precision measurement systems, and other equipment. The Engineer also helps assess and develop container closure systems; characterizes device function, assembly, and manufacturability using CAE and traditional engineering techniques; and tests mechanical or electromechanical systems on bench-top models or production-representative units during design development and verification. The position liaises with specialist manufacturers, toolmakers, and other third parties, communicates with internal departments and external suppliers, and aligns work with company quality assurance and applicable regulatory requirements. Duties are generally conducted in an office environment. Employees must be able, with or without accommodation, to use a computer; communicate by phone, video, and electronic messaging; engage in problem solving, analysis, and dialogue; collaborate with others; and maintain general availability during standard business hours. The role is based in Boston, Massachusetts, with hybrid work averaging at least three days per week in the office, or in New Haven, Connecticut. The annual base-pay range is $101,643.20–$152,464.80. The position is eligible for incentives, including short-term incentive bonuses and equity-based awards for salaried roles. Benefits include qualified retirement programs, paid time off (vacation, holidays, and leaves), and health, dental, and vision coverage, subject to applicable plan terms.

Requirements

Bachelor’s degree in Biomedical, Chemical, Mechanical, or Electrical Engineering.
Experience in design control activities.
Knowledge of primary containers and drug delivery.
Understanding of mold and fixture design and build, as well as validation processes (IQ/OQ/PQ).
Experience collaborating with medical device vendors and tooling companies.
Knowledge of regulatory and compliance requirements for device design controls and combination products, including FDA QSR 21 CFR Part 4 and 820/ISO 13485 quality system requirements.
Ability to use a computer and communicate by phone, video, and electronic messaging, with or without accommodation.
Ability to engage in problem solving, analysis, dialogue, and collaboration, and maintain general availability during standard business hours.

Nice To Haves

Four to six years of experience in medical device development.
Experience with injector-based combination products.

Responsibilities

Support device development activities with the device engineering team to develop and bring combination products to market.
Work with device partners on the creation, evolution, optimization, and verification of designs and hardware for drug-delivery devices, associated test equipment, precision measurement systems, and other equipment.
Help assess and develop innovative container closure systems.
Characterize device function, assembly, and manufacturability using 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, including specialist manufacturers and toolmakers.
Communicate verbally and in writing with internal departments and external suppliers.
Align work with company quality assurance requirements and applicable regulatory requirements.
Assist with technology transfer and support technical design and development activities for device and combination products.