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About the Role

Serve as a Development Engineer within the Alexion Device Development organization, acting as the technical SME/project engineer supporting the development of combination products. This role is accountable for key technical design and development deliverables and will interact with multiple functions and teams from clinical 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 devices such as pre-filled syringes, autoinjectors, pen injectors, and on-body delivery systems.
• Manage technical development facets, including interactions with suppliers, CMOs, technology vendors, and internal cross-functional teams.
• Oversee characterization and design verification testing, determining relevant success criteria, and managing method development, qualification, and transfer.
• Author technical documentation for the development process or design control deliverables.
• Perform root cause analysis of product or process deviations or failures using Six Sigma tools.
• Clearly communicate learnings and educate team members on methods and analytical approaches.
• Act independently within team expectations, coordinate with functional leadership, and complete tasks with autonomy.
• Demonstrate technical rigor, creativity, continuous learning, and alignment with customer needs.
• Exhibit strong accountability and responsibility for the successful and timely completion of designated tasks.

Requirements

• BS Degree in Mechanical, Biomedical, Chemical Engineering, 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.
• Experience with combination products, specifically prefilled syringes, autoinjectors, pen injectors, and on-body injectors is 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.
• 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.
• Intellectual curiosity to deeply understand technical concepts.
• Knowledge of performance and regulatory compliance (EU and FDA) requirements for 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 / ISO13485 quality system requirements).
• Ability to use a computer, engage in communications, problem-solving, analysis, and collaboration, and maintain general availability during standard business hours.

Skills

• Statistical analysis
• Analytical tools
• Benchtop testing
• Root cause analysis
• Team building
• Collaboration
• Technical communication

Location

• Boston, MA
• New Haven, CT

Work Type

• Office environment

Experience Level

• 6+ years

Education Level

• BS Degree
• Master's Degree preferred
• PhD Degree preferred

Salary/Compensations

• $97,000 to $146,000

Benefits

• Short-term incentive bonus opportunity
• Equity-based long-term incentive program (salaried roles)
• Retirement contribution (hourly roles)
• Qualified retirement program (401(k) plan)
• Paid vacation and holidays
• Paid leaves
• Health benefits including medical, prescription drug, dental, and vision coverage

About the Company

• Alexion Device Development organization
• Alexion Dublin Manufacturing Facility (ADMF)

Equal Opportunity

• We build an inclusive environment where equal employment opportunities are available to all applicants and employees.
• 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.