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. This role will be accountable for key technical design and development deliverables. This 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/identification of critical dimensions, systems engineering, sensitivity analysis, tolerance stack‑ups, and technical assessments via analytical and empirical means.
• Managing facets of technical development, interacting with suppliers, CMOs, technology vendors, and internal cross‑functional teams.
• Overseeing characterization and design verification testing, determining relevant success criteria, and developing, qualifying, and transferring appropriate methods.
• Authoring 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 investigations.
• Communicating learnings and educating team members on methods and analytical approaches.
• Acting independently within team expectations, coordinating with functional leadership to identify priorities, and completing tasks under one's accountability while maintaining a high level of autonomy.
• Demonstrating technical rigor, creativity, continuous learning, improvement, and alignment to customer needs and value creation.
• Demonstrating strong and clear accountability/responsibility for the successful and timely completion of designated tasks.

• 6+ years of experience as a product design/development engineer in the medical device or pharmaceutical industries or related experience (experience with combination products, specifically prefilled syringes, autoinjectors, pen injectors, and on‑body injectors preferred).
• 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 (e.g., Minitab, Crystal Ball), analytical tools (e.g., FEA), benchtop testing (e.g., Zwick, fixture design), and experience in root cause analysis/investigation.
• Strong team building and collaboration skills across the organization and intellectual curiosity to deeply understand technical concepts.
• Knowledge of performance and regulatory compliance (EU and FDA) requirements of medical device 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).
• Role duties are generally conducted in an office environment; employees must be able, with or without an accommodation, to use a computer, engage in communications via phone, video, and electronic messaging, problem‑solve, collaborate, and maintain general availability during standard business hours.

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

The annual base salary for this position ranges from $97,000 to $146,000; 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;…