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Form of workAZN26807 Human Factors Engineer , New Haven, CT 6 Months
Sigma Inc is currently looking for an Human Factors Engineer for their pharmaceutical client Astra Zeneca in New Haven, CT who will work with their Global Product Development team participating in Usability/Human Factors for pipeline combination products.
Responsibilities:
Sigma Inc is currently looking for an Human Factors Engineer for their pharmaceutical client Astra Zeneca in New Haven, CT who will work with their Global Product Development team participating in Usability/Human Factors for pipeline combination products.
Responsibilities:
- 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.
- 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
- 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).
- 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; analysis, and dialogue; engage in problem solving and non-linear thought collaborate with others; maintain general availability during standard business hours.
