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Senior Engineer II, Human Factors, Device Development

Location New Haven, Connecticut, United States Boston, Massachusetts, United States Job ID R-172235 Date posted 09/01/2024

**Hybrid means onsite 3 days per week**

This is what you will do:

This position will serve the role of Sr Engineer II for Human Factors of Alexion combination products within Global Product Development function of Alexion. The candidate will participate in the Human Factors / Usability Engineering for pipeline combination products as well as lifecycle management. This position will manage the human factors deliverables, overall user interface evaluation, study design, development of labeling, integration of user needs, use risk analysis and HF vendor selection. This role will interact with multiple functional teams including Clinical, Global Drug Safety, Marketing, Quality, and Regulatory, from clinical development through registration and commercial 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
  • Member of device development team responsible for determining the strategy for human factors/ usability engineering activities from formative studies to final HF validation for combination products.
  • Lead user related risk analysis for the programs under development.
  • Conduct competitive analysis, market sensing, complaint handling to inform new product design (inclusive of device, labeling and secondary packaging)
  • Educate team members and other internal stakeholders on the Human Factors development process and approach
  • Interface with HF consulting firms for their capability and build alliances with peer HF professionals throughout the industry for HF/ usability best practice benchmarking.
  • Communicate effectively, both verbally and in writing, internally across departments and with external suppliers.
  • Ensure all human factors engineering comply with the Company’s quality assurance requirements as well as applicable regulatory requirements.

You will need to have:

  • Experience in commercialization of medical device and/or combination products. 
  • Deep knowledge of regulatory and compliance requirements for device risk management and human factors/usability engineering for combination product. 
  • Working experience in phase-based design control activities with integrated risk management deliverables and human factors/usability engineering studies, from research through registration, launch and life cycle management. 
  • Demonstrated ability to facilitate the interface among the pharmaceutical company, the medical device vendors, and HF consulting firms. 
  • Strong communication, collaboration and team building skills; ability to connect with all levels of the organization.  Proficient in writing internal reports, project summaries, and internal/external presentations.  
  • Deep knowledge of human factor/usability engineering, safety, 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, and related FDA HF guidance). 
  • 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 in Engineering(Human Factors, Biomedical, Mechanical, Electrical Engineering, or Chemical) plus 10 to 12 year’s experience orMaster’s / Doctorate in Engineering(Human Factors, Biomedical, Mechanical, Electrical Engineering, or Chemical)plus 8 to 10 year experience inmedical device development in Ergonomics and HumanExperience with injector based combination product preferred

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. 

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

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AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

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