Engineer III, Device Development

Engineer III Device Development / Human Factors Engineering

This position will serve the role of Engineer III for device development / human factors engineering within the Alexion Device Development organization. The role will support the human factors work streams for pipeline products as well as lifecycle management. This role will interact with multiple functional teams including Device Development, Clinical, Commercial/Marketing, Quality, and Regulatory, clinical development through registration and commercial product support.

You will be responsible for:

• Lead and support activities under the human factors and usability engineering process for combination product design and development from feasibility, clinical development through registration and post-market.
• Support core teams to develop and support the strategy for human factors/usability engineering activities from formative studies to final HF validation for combination products.
• Support design validation activities including summative human factors study (i.e. human factors validation) from protocol development, study execution, and reporting.
• Provide feedback and/or author for user need identification and user interface specifications development.
• Provide feedback to use-related risk management activities such as known use problem analysis, hazard analysis, and use-related risks analysis
• Draw findings from competitive analysis, market sensing, complaint handling to inform new product design (inclusive of device, labeling and secondary packaging)
• Collaborate with human factors firms (vendors) and manage their activities for a formative or summative human factors study.
• Communicate effectively, both verbally and in writing, internally across departments and with external suppliers.
• Ensure all human factors engineering activities as required and comply with the Company's quality assurance requirements as well as applicable regulatory requirements.
• Support feasibility activity of device assessment (e.g., testing, fixturing, protocol, report).

You will need to have:

• Experience in human factors engineering and exposure to design and development of medical device and combination products.
• Experience in design control activities.
• Ability to manage external human factors firms (vendors).
• Strong communication and collaboration skills; ability to connect with all levels of the organization. Proficient in writing internal reports, project summaries, and internal/external presentations.
• Knowledge of human factor/usability engineering, safety, performance and regulatory compliance requirements of medical device and combination products (e.g. IEC 62366, FDA HF guidances, EU Regulation 2017/745 (MDR)).
• [For office-based positions:] 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.

We would prefer for you to have:

• Bachelor's or Master's degree in Engineering (Biomedical, Chemical, Mechanical, Electrical Engineering or Human Factors) plus 3-6 years experience in medical device Human Factors development and design control.
• Experience with injection based combination product development and risk management preferred.
• Experience with graphics design a plus.

Joining Alexion means embracing an opportunity where work isn't ordinary. We are a beacon in the global Biopharmaceutical landscape. Our closeness to patients brings us closer to our work and each other. Combined with our brave, pioneering spirit – we are truly unique in R&D and healthcare. At Alexion, grow and innovate in a business with a rapidly expanding portfolio. Enjoy the entrepreneurial spirit of a leading biotech while meeting the needs of some of the most under-served patients in the world.

You will be empowered with tailored development programs designed not just for skill enhancement but for fostering a deep understanding of our patient's journeys. Supported by outstanding leaders and peers ready to lift you in…