Development Engineer

About

The Development Engineer will serve within the Alexion Device Development organization as the technical SME/project engineer supporting the development of combination products. The role is accountable for key technical design and development deliverables and will interact with Device Quality, Regulatory Affairs, Clinical, Global Technical Operations (GTO), and Alexion Dublin Manufacturing Facility (ADMF) from clinical development through commercial development.

Responsibilities

• Deep understanding of device design, including development/identification of critical dimensions, systems engineering, sensitivity analysis, and tolerance stack‑ups; conduct technical assessments via analytical and empirical means for pre‑filled syringes, autoinjectors, pen injectors, and on‑body delivery systems.
• Manage facets of technical development, including interactions with suppliers, CMOs, technology vendors, and internal cross‑functional teams.
• Oversee characterization and design verification testing; determine relevant success criteria; develop, qualify, and transfer appropriate methods.
• Author technical documentation supporting the development process or design control deliverables.
• Perform root cause analysis of product or process deviations or failures; utilize Six Sigma tools to manage investigations.
• Clearly communicate learnings and educate team members on methods and analytical approaches.
• Act independently within team expectations, coordinate with functional leadership to identify priorities, and complete tasks with a high level of autonomy.
• Demonstrate technical rigor, creativity, continuous learning, alignment to customer needs, and strong accountability for timely task completion.

Requirements

• 6+ years of experience as a product design/development engineer in the medical device or pharmaceutical industries (experience with combination products—prefilled syringes, autoinjectors, pen injectors, on‑body injectors—preferred).
• Experience developing products or implementing product changes through a structured, phase‑gated product development process.
• Demonstrated experience with all phases of the Design Control process.
• Experience in a technical product development role on a cross‑functional team; leadership experience preferred.
• Understanding of medical device product development risk management methodologies.
• Expertise in statistical analysis (Minitab, Crystal Ball, etc.), analytical tools (e.g., FEA), benchtop testing (e.g., Zwick, fixture design), and root cause analysis/investigation.
• Strong team‑building and collaboration skills; intellectual curiosity to deeply understand technical concepts.
• Knowledge of performance and regulatory compliance (EU and FDA) requirements for medical devices and combination products (e.g., IEC 62366, ISO 11608 series, ISO 14971, IEC 60601 series, FDA QSR 21 CFR Part 820 / ISO 13485).

Preferred Qualifications

• Bachelor’s, Master’s, or PhD in Engineering (Mechanical, Biomedical, Chemical, Materials Science) or a closely related discipline.
• 6–10 years of experience in medical device/container closure development with 2+ years in combination product commercialization.

Compensation & Benefits

• Annual base salary range: $97,000 – $146,000 (varies based on location, knowledge, skills, and experience).
• Short‑term incentive bonus opportunity.
• Eligibility for equity‑based long‑term incentive program (salaried roles) or retirement contributions (hourly roles).
• Qualified retirement program (401(k) plan).
• Paid vacation, holidays, and leaves.
• Health benefits including medical, prescription drug, dental, and vision coverage.

The role is office‑based; employees must be able to use a computer, communicate via phone/video/e‑mail, engage in problem solving and analysis, collaborate with others, and maintain general availability during standard business hours.