Human Factors Engineer - Device Development

ONSITE 3 DAYS PER WEEK, NEW HAVEN, PARKING REIMBURSED

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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.

This is what you will do :

This position will serve the role of Sr Engineer 2 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 :

We would prefer for you to have :

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