Engineer III, Device Development

Alexion•Boston, MA

4d•Hybrid

About The Position

This position serves as an Engineer III for device development of Alexion products, including continuous product improvement within Alexion’s Development function. The successful candidate supports technical design and development activities for device and combination products and assists with technology transfer. The role supports the development and commercialization of combination products, working with device partners to create, evolve, optimize, and verify designs and hardware for drug delivery devices, associated test equipment, precision measurement systems, and related equipment. It also contributes to the assessment and development of container closure systems and conducts characterization of device function, assembly, and manufacturability using computer-aided engineering (CAE) and traditional engineering techniques. The position tests mechanical or electromechanical systems using bench-top models or production-representative units during design development and verification. It liaises with specialist manufacturers, toolmakers, and other external suppliers, communicates across departments, and works in alignment with company quality assurance and applicable regulatory requirements. The role is generally conducted in an office environment, with an average expectation of working from the office at least three days per week. Locations are Boston, Massachusetts, or New Haven, Connecticut.

Requirements

Bachelor’s degree in Engineering, such as 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, and application of 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.

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 to create, evolve, optimize, and verify designs and hardware for drug delivery devices, associated test equipment, precision measurement systems, and related 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 effectively in writing and verbally with internal departments and external suppliers.
Align work with company quality assurance requirements and applicable regulatory requirements.
Assist with technology transfer.