Human Factors Engineer 3, Device Development

AstraZeneca; Boston (MA); On-site; USD 102,000 - 133,000; Full time

Job summary

AstraZeneca is seeking an Engineer III in the Alexion Device Development organization to lead human factors and usability engineering across pipeline products and lifecycle management. You will collaborate with multiple teams to ensure HF activities comply with quality and regulatory requirements.

The role requires experience in HF engineering, design control, and managing external HF vendors, with strong communication across levels and departments. Office-based role with standard business hours.

Qualifications

• Experience in human factors engineering for medical device development and design control.
• Proficient in writing internal reports, project summaries, and presentations.
• Ability to manage external human factors firms (vendors).

Responsibilities

• Lead and support human factors activities from feasibility to post-market.
• Support HF strategy from formative studies to HF validation.
• Oversee design validation activities including summative HF studies.
• Provide feedback for user needs and UI specifications.
• Contribute to use-related risk management and hazard analysis.
• Inform product design from competitive analysis and market sensing.

Skills

Human factors engineering

Design control

Vendor management

Communication

Education

Bachelor's or Master's in Engineering

Job description

This is what you will do:

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 workstreams 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 marketing, compliance, and beyond.

The annual base pay (or hourly rate of compensation) for this position ranges from $101,643.20 to $133,406.70. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

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.