ONSITE 3 DAYS PER WEEK, NEW HAVEN, PARKING REIMBURSED 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: 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. P roficient 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). [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 in Engineering (Human Factors, Biomedical, Mechanical, Electrical Engineering, or Chemical) plus 10 to 12 years experience or Master's / Doctorate in Engineering (Human Factors, Biomedical, Mechanical, Electrical Engineering, or Chemical) plus 8 to 10 year experience in medical device development in Ergonomics and Human Experience with injector based combination product preferred #J-18808-Ljbffr Nesco Resource
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