Engineer IV, Device Development

at  Alexion PharmaceuticalsInc

Location: New Haven, United States
Job reference: R-207927
Date posted: 08/28/2024
This is what you will do:
This position will serve the role of Engineer IV for device development of Alexion products including Development, Launch and Post-Market support 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:

• Drive/support device development activities with the Device Core Team to development and bring to market combination product.
• Manage timeline for development as well as life cycle management for combination products.
• Work with device partners in the creation, evolution, optimization and verification of designs and hardware for drug delivery devices.
• Evaluate device design, function, assembly, manufacturability, and support verification/validation of drug delivery combination products.
• Lead the Design Control Activities including documentation, sample preparation and defining with the lab the appropriate testing method/equipment.
• Drive and facilitate team exercise on risk analysis, evaluation, and control as well as all compile risk management documentation.
• Help assess and develop innovative container closure systems.
• Conduct characterization for device function, assembly, manufacturability, etc. using both CAE and engineering techniques such as 1st principal modeling, DOE, FEA, …
• Understand process development and key process parameter identification, specification definition,..
• Consult 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.
• Deep knowledge is DOE, statistics, simulation, and method development/validation
• 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).

We would prefer for you to have:

• Bachelor’s Degree in Engineering (Biomedical, Chemical, Mechanical, or Electrical Engineering) plus 6-8 years of experience in medical device development. Experience with injector-based combination product preferred.

The annual base salary for this position ranges from $104,000 to $156,000. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles) or to receive a retirement contribution (hourly roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

• Drive/support device development activities with the Device Core Team to development and bring to market combination product.
• Manage timeline for development as well as life cycle management for combination products.
• Work with device partners in the creation, evolution, optimization and verification of designs and hardware for drug delivery devices.
• Evaluate device design, function, assembly, manufacturability, and support verification/validation of drug delivery combination products.
• Lead the Design Control Activities including documentation, sample preparation and defining with the lab the appropriate testing method/equipment.
• Drive and facilitate team exercise on risk analysis, evaluation, and control as well as all compile risk management documentation.
• Help assess and develop innovative container closure systems.
• Conduct characterization for device function, assembly, manufacturability, etc. using both CAE and engineering techniques such as 1st principal modeling, DOE, FEA, …
• Understand process development and key process parameter identification, specification definition,..
• Consult 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