Senior Engineer , Device Development

Location: Boston, MA or New Haven, CT

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

• Deep understanding of the device design, including development and identification of critical dimensions, systems engineering, sensitivity analysis, and tolerance stack‑ups. Conduct technical assessments via analytical and empirical means for devices such as pre‑filled syringes, autoinjectors, pen injectors, and on‑body delivery systems.
• Based on understanding of device design, manage facets of technical development, including interactions with suppliers, CMOs, technology vendors, and internal cross‑functional teams.
• Oversee the characterization and design verification testing and determine relevant success criteria; develop, qualify, and transfer appropriate methods.
• Author technical documentation in support of the development process or design control deliverables.
• Root cause analysis of product or process deviations or failures, utilizing six sigma tools to manage investigation.
• Clearly communicate learnings and educate other team members on methods and analytical approaches.
• Act independently within team expectations, coordinate with functional leadership to identify priorities, and complete tasks under own accountability while balancing a high level of autonomy.
• Demonstrate technical rigor and creativity, continuous learning and improvement, and alignment to customer needs and value creation.
• Demonstrate strong and clear accountability/responsibility for successful and timely completion of designated tasks.

• BS Degree in Mechanical, Biomedical, Chemical Engineering, or Materials Science and Engineering, or closely related disciplines.
• 6+ years of experience as a product design/development engineer in the medical device or pharmaceutical industries, with preference for experience with combination products, specifically pre‑filled syringes, autoinjectors, pen injectors, and on‑body injectors.
• Experience with developing products or implementing product changes through a structured, phase‑gated product development process.
• Demonstrated experience with all phases of the Design Control process.
• Demonstrated experience in a technical, product development role on a cross‑functional team; leadership role 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 across the organization, with intellectual curiosity to deeply understand technical concepts.
• Knowledge of performance and regulatory compliance (EU and FDA) requirements of medical devices and combination products (e.g., IEC 62366, ISO 11608 series, ISO 14971, IEC 60601 series, FDA QSR 21 CFR Part 4 and 820 / ISO
  13485 quality system requirements).
• The duties of this role are generally conducted in an office environment; employees must be able to use a computer, engage in communications via phone, video, and electronic messaging, perform problem solving, and collaborate with others during standard business hours.

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

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.