Engineer III, Device Development
AstraZeneca
Summary
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.
Job description
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 develop and bring to market combination products.
- 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).
- 4-6 year experience in medical device development preferred.
- Experience with injector-based combination product preferred.
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)
- 4-6 year experience in medical device development preferred
- Experience with injector-based combination product preferred
Benefits
- Short-Term Incentive Bonuses
- Equity-Based Awards
- Retirement Programs
- Paid Time Off
- Health Insurance
- Dental Insurance
- Vision Coverage
Company overview
AstraZeneca is a global, science-led, patient-focused pharmaceutical company dedicated to accelerating the delivery of life-changing medicines that create enduring value for patients, society, and shareholders. With a workforce of over 94,300 employees worldwide, the company operates across three core therapy areas: Oncology, BioPharmaceuticals (including Cardiovascular, Renal & Metabolism, Respiratory & Immunology), and Rare Disease. Headquartered in Cambridge, UK, AstraZeneca maintains strategic R&D centers in Cambridge, Gaithersburg (US), Boston (US), Gothenburg (Sweden), Shanghai, and Beijing. The company generated $54.1 billion in total revenue in 2024 and invested $13.6 billion in scientific research and development. AstraZeneca's bold aspiration is to be pioneers in science, lead in disease areas, and transform patient outcomes, with a goal to launch 20 new medicines and achieve $80 billion in total revenue by 2030. The company is recognized for its commitment to sustainability, health equity, and creating an inclusive work environment where diverse perspectives drive innovation.