This is what you will do:
This position will serve the role of Engineer II 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 input for user need identification and user interface specifications development.
- Author use-related risk management activities such as known use problem analysis, hazard analysis, and use-related risks analysis
- Draw learnings from competitive analysis, market sensing, complaint handling to inform new product design (inclusive of device, labeling and secondary packaging)
- Interface 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.
- Awareness of 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 0-3 year experience in medical device Human Factors development.
- Experience with injection based combination product development and risk management preferred.
- Experience with graphics design a plus.
Date Posted
10-May-2024
Closing Date
20-Jun-2024Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact [email protected]. Alexion participates in E-Verify.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
What We Do
Our mission is to transform the lives of people living with rare diseases and devastating conditions through the development and delivery of innovative medicines, as well as through supportive technologies and healthcare services.
By continuing to deepen our understanding of rare disease, which began with our pioneering work in complement biology, we are able to innovate and evolve into new areas where there is great unmet need and opportunity to help patients and families fully live their best lives.
Our culture is rooted in integrity, inclusiveness, and our dedication to joining and supporting the communities in which we live and work. We invest in and value people who believe in the importance of our purpose and understand what it takes to deliver on it. Alexion has over 3,000 talented colleagues dedicated to serving people living with rare diseases in more than 50 countries around the world. Our global headquarters are based in Boston, Massachusetts and our EMEA headquarters are in Zürich, Switzerland. We also have a Research Center of Excellence in New Haven, Connecticut, global supply chain and operations headquarters in Ireland, as well as local and regional operations in countries around the world.
At Alexion, our passion drives us to continuously innovate and create meaningful value in all we do. In doing so, we change lives for the better – ours, people living with rare diseases, and the communities we serve. Every day.
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