Engineer I, Device Development

Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.This is what you will do:This position will serve the role of Engineer I 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.You will be responsible for:* Manage medical device test method and specification development, including test method development, validation, transfer, and life cycle management.* Support the laboratory operation such as sample inventory, equipment qualification and maintenance.* 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.* Comply with the Company''s quality assurance requirements as well as applicable regulatory requirements.You will need to have:* 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).* Interface 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 a lab environment. As is typical of a lab-based role, employees must be able, with or without an accommodation to: lift/carry 15-30 pounds unassisted/assisted; work comfortably in a controlled environment with and around biological, infectious, and hazardous materials; gown/de-gown PPE; 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.We would prefer for you to have:* Bachelor''s degree in Engineering (Biomedical, Chemical, Mechanical, or Electrical Engineering) plus 1 to 3 year experience in laboratory. Experience with injector based combination product preferred.LI-SM1Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. Further information about Alexion can be found at: is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion has taken critical steps to protect colleagues, loved ones, and patients from COVID-19 and its variants. All US-based employees must comply with Alexion''s COVID-19 vaccination mandate. Alexion provides exceptions based on applicable state law as well as reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding a legally required exemption or accommodation, please contact [Click Here to Email Your Resumé]. Alexion participates in E-Verify.As a leading employer in our industry, Alexion offers a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, and much more.AstraZeneca completed its acquisition of Alexion, marking the creation of Alexion, AstraZeneca Rare Disease. If you''re interested in career opportunities with AstraZeneca, click here.

Created: 2025-11-15