Location: Boston, MA or New Haven, CT

This is what you will do:

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.

You will be responsible for:

• Deep understanding of the device design, including development/identification of critical dimensions, systems engineering, sensitivity analysis, tolerance stackups, and technical assessments via analytical and empirical means.
• Managing facets of technical development, interacting with suppliers, CMOs, technology vendors, and internal crossfunctional 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.

You will need to have:

• 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 onbody injectors preferred).
• Experience with developing products or implementing product changes through a structured, phasegated, product development process.
• Demonstrated experience with all phases of the Design Control process.
• Demonstrated experience in a technical, product development role on a crossfunctional 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 / ISO13485 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, problemsolve, collaborate, and maintain general availability during standard business hours.

We would prefer for you to have:

• Bachelor, Master's, or PhD Degree in Engineering (Mechanical, Biomedical, Chemical, or Materials Science and Engineering) or closely related disciplines preferred.
• 610 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, jobrelated knowledge, skills, and experience. In addition, our positions offer a shortterm incentive bonus opportunity; eligibility to participate in our equitybased longterm incentive program (salaried roles) or to receive a retirement contribution (hourly roles). Benefits offered include 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 "atwill 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.

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, 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.