Engineer III, Device Development Boston, Massachusetts, Engineering Operations

## Engineer III, Device Development Boston, Massachusetts, United States of America Apply Now Find out how well you match with this job
** 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/ISO
13485 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.

Ready to lead and encourage? Apply now and take the first step towards a fulfilling career at Alexion, AstraZeneca Rare Disease.#LI-Hybrid
* The annual base pay for this position ranges from  -  USD. Our positions offer eligibility for various incentives—an opportunity to…