Senior Engineer I, Device Development

AstraZeneca • East Meadow, NY

6d • $97,000 - $146,000 • Onsite

About The Position

This position will serve as a Development Engineer within the Alexion Device Development organization, acting as the technical Subject Matter Expert (SME) and project engineer supporting the development of combination products. The candidate will be accountable for key technical design and development deliverables and will interact with multiple functions and teams, including Device Quality, Regulatory Affairs, Clinical, Global Technical Operations (GTO), and Alexion Dublin Manufacturing Facility (ADMF), throughout the clinical and commercial development phases.

Requirements

• 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 or related experience.
• 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.
• 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).
• Ability to use a computer, engage in communications via phone, video, and electronic messaging, engage in problem solving and non-linear thought, analysis, and dialogue, collaborate with others, and maintain general availability during standard business hours, with or without accommodation.

Nice To Haves

• Experience with combination products, specifically prefilled syringes, autoinjectors, pen injectors, and on-body injectors.
• 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.
• 2+ years in combination product commercialization.

Responsibilities

• Serve as the technical SME/project engineer supporting the development of combination products.
• Act as the technical lead for key technical design and development deliverables.
• 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.
• Develop a deep understanding of device design, including critical dimensions, systems engineering, sensitivity analysis, and tolerance stack-ups.
• Conduct technical assessments using analytical and empirical means for devices such as pre-filled syringes, autoinjectors, pen injectors, and on-body delivery systems.
• Manage facets of technical development, including interactions with suppliers, CMOs, technology vendors, and internal cross-functional teams.
• Oversee characterization and design verification testing, determine relevant success criteria, and develop, qualify, and transfer appropriate methods.
• Author technical documentation for the development process and design control deliverables.
• Perform root cause analysis of product or process deviations or failures, utilizing Six Sigma tools.
• Clearly communicate learnings and educate team members on methods and analytical approaches.
• Act independently within team expectations, coordinate with functional leadership to identify priorities, and complete tasks with a high level of autonomy.
• Demonstrate technical rigor, creativity, continuous learning, and alignment to customer needs and value creation.
• Demonstrate strong accountability and responsibility for the successful and timely completion of designated tasks.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior