Senior Engineer , Device Development

Location:
Boston, MA or New Haven, CT

• Position will serve as Development Engineer within Alexion Device Development organization.
• Act as technical SME/project engineer supporting combination products.
• Accountable for key technical design and development deliverables.
• Interact with multiple functions (Device Quality, Regulatory Affairs, Clinical, GTO, and ADMF) from clinical development through commercial development.

• Deep understanding of device design: development, identification of critical dimensions, systems engineering, sensitivity analysis, tolerance stack‑ups.
• Technical assessments via analytical and empirical methods.
• Devices: pre-filled syringes, autoinjectors, pen injectors, on-body delivery systems.
• Based on device understanding, manage facets of technical development, including interactions with suppliers, CMOs, vendors, and cross‑functional teams.
• Oversee characterization and design verification testing, determine success criteria, develop, qualify, and transfer methods.
• Author technical documentation for development or design control deliverables.
• Root cause analysis of product or process deviations or failures using Six Sigma tools.
• Communicate learnings and educate team on methods and analytical approaches.
• Act independently within team expectations, coordinate with functional leadership, balance autonomy.
• Demonstrate technical rigor, creativity, continuous learning, and alignment to customer needs.
• Show strong accountability for timely completion of tasks.

Additional responsibilities:

• Perform duties in an office environment; use computer, communicate via phone, video, and electronic messaging; engage in problem solving, analysis, collaboration, and maintain availability during standard business hours.

• BS Degree (Mechanical, Biomedical, Chemical Engineering, Materials Science, or related disciplines).
• 6+ years of experience as a product design/development engineer in medical device or pharmaceutical industries (or related). Preference for experience with combination products such as prefilled syringes, autoinjectors, pen injectors, and on-body injectors.
• Experience developing products or implementing 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 role preferred.
• Understanding of medical device product development risk management methodologies.
• Expertise in statistical analysis (Minitab, Crystal Ball), analytical tools (FEA), benchtop testing (Zwick, fixture design) and experience in 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 of medical device and combination products (IEE 62366, ISO 11608 series, ISO 14971, IEC 60601 series, FDA QSR 21 CFR Part 4 and 820 / ISO
  13485).

• Master’s or PhD Degree in Engineering (Mechanical, Biomedical, Chemical, or Materials Science and Engineering) or related disciplines.
• 6‑10+ years of 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. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, positions offer a short‑term incentive bonus opportunity; eligibility to participate in an equity‑based long‑term incentive program (salaried roles) or to receive a retirement contribution (hourly roles). Benefits include a qualified retirement program (401(k)), paid vacation and holidays, paid leaves, and health benefits including medical, prescription drug, dental, and vision coverage in accordance with applicable plans.

Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, the employee will be in an “at‑will 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.

Date Posted: 08-Jun-2026

Closing Date: 09-Jul-2026

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.