Senior Engineer I, Device Development

About the role

This position serves 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.

Responsibilities

• Deep understanding of the device design: this may include development/identification of critical dimensions, systems engineering, sensitivity analysis, tolerance stack-ups.
• Technical assessments to be conducted via analytical and empirical means.
• Devices of interest include: pre-filled syringes, autoinjectors, pen injectors, and on-body delivery systems.
• Manage facets of technical development, including interactions with suppliers, CMOs, technology vendors, and/or internal cross-functional teams.
• Oversee the characterization and design verification testing as well as determine relevant success criteria. This includes development, qualification, and the transfer of the appropriate methods.
• Author technical documentation in support of the development process or design control deliverables.
• Root Cause analysis of product or process deviations or failures. Utilization of six sigma tools to manage the investigation.
• Clearly communicate learnings and educate other team members on methods and analytical approaches.
• Act independently within team expectations, coordinate with functional leadership to identify priorities, complete tasks under his/her accountability while balancing a high level of autonomy.
• Demonstrate technical rigor and creativity, continuous learning and improvement, and alignment to customer needs and value creation.
• Demonstrate strong and clear accountability/responsibility for successful and timely completion of designated tasks.

Requirements

• BS Degree (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 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.
• Possesses expertise in statistical analysis (Minitab, Crystal Ball, etc), 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. Possesses 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).

Qualifications

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

Skills

• Ability to conduct technical assessments via analytical and empirical means.
• Expertise in statistical analysis, analytical tools, benchtop testing, and root cause analysis.
• Strong communication and collaboration skills.
• Experience with medical device product development risk management methodologies.
• Knowledge of regulatory compliance requirements for medical devices and combination products.

Benefits

• Annual base salary ranging from $97,000 to $146,000.
• Short-term incentive bonus opportunity.
• Equity-based long-term incentive program (salaried roles) or 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.

Pay

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.

Schedule

The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation 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; maintain general availability during standard business hours.