Engineer I Device Development

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 development, validation, transfer, and lifecycle management. 
• Support laboratory operations, including sample inventory management, equipment qualification, and maintenance. 
• Conduct device characterization for function, assembly, and manufacturability using CAE and traditional engineering techniques. 
• Test mechanical and electromechanical systems on benchtop models and production-representative units during design development and verification. 
• Liaise with third-party partners, including specialist manufacturers and toolmakers. 
• Interface with medical device vendors and tooling companies. 
• Communicate effectively, both verbally and in writing, across internal departments and with external suppliers. 
• Ensure compliance with company quality assurance requirements and applicable regulatory requirements. 

You will need to have: 

• Bachelor’s degree in Biomedical Engineering, Chemical Engineering, Mechanical Engineering, Electrical Engineering, or a related engineering discipline. 
• 1 to 3 years of laboratory experience. 
• Experience in design control activities. 
• Knowledge of primary containers and drug delivery systems. 
• Understanding of mold and fixture design and build. 
• Understanding of validation processes, including IQ, OQ, and PQ. 
• Experience or familiarity with interfacing 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, 21 CFR Part 820, and ISO 13485. 
• Strong written and verbal communication skills. 
• Ability to collaborate across functions and support technical problem-solving in a laboratory-based development environment. 
• Ability to work in a lab environment, with or without reasonable accommodation. 
• Ability to lift and carry 15-30 pounds unassisted or assisted. 
• Ability to work comfortably in a controlled environment with and around biological, infectious, and hazardous materials. 
• Ability to gown and de-gown personal protective equipment (PPE). 
• Ability to use a computer for routine work activities. 
• Ability to engage in communications via phone, video, and electronic messaging. 
• Ability to engage in problem solving, non-linear thought, analysis, and dialogue. 
• Ability to collaborate effectively with others. 
• Ability to maintain general availability during standard business hours. 

We would prefer for you to have: 

• Experience with injector-based combination products. 
• Experience supporting device verification activities. 
• Experience with technology transfer activities. 
• Experience supporting laboratory equipment qualification. 
• Familiarity with medical device testing in a regulated environment. 
• Experience supporting continuous product improvement initiatives. 

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.