Planet Pharma · 1 week ago
Human Factors Design Eng II
North Haven, CT
Full-time
Onsite
Entry, Mid Level
2+ years expPlanet Pharma is a company focused on developing advanced surgical technologies. The Human Factors Design Engineer II will lead human factors efforts, focusing on usability studies, user research, and risk analysis to enhance product design and user experience.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Designing usability studies and driving testing strategies
Moderating usability testing of prototypes with end users and customers
Aiding in data collection and root cause analysis during usability testing
Responsible for Use-related Risk Analysis documentation
Provide technical insight for user interface design, HF processes, and planning for team and business strategy
Perform observation / contextual inquiry for applicable use cases/environments e.g. Surgery
Moderate interviews with end users and customers for the purpose of need finding, use case identification, use condition identification, use error identification, validation of customer and user needs, and determining effectiveness of risk controls
Contribute and maintain human factors program documentation as needed for the Usability Engineering File
Aiding teams with preparation of usability-related documentation for regulatory body submissions
Aid in identifying use-related issues upon post-market launch and provide recommendations of risk control enhancements
Applies human centered principles, methodologies, and technologies to the design of human-machine systems and products
Develops and implements research methodologies and both qualitative and quantitative analysis plans to test and evaluate new concepts and developmental prototypes used in all phases of products development and processes
Designs and executes tests to simulate product use for the purposes of user need investigation, concept exploration/selection/refinement, requirements development, use-related risk identification and formal usability validation with intended users with design engineers to establish system design, operating, and training requirements and to ensure optimized human-machine interfaces and overall user experience
Identifies and analyzes technological problems or risks, performs theoretical human factors investigations, and develops and implements research and analysis plans to inform the design direction of new product development
Qualification
Required
BS in Human Factors or a closely-related field (such as Biomedical Engineering, Industrial Design, Industrial Engineering) with 2+ years' experience
Planning, conducting, and documenting usability testing in a medical device use context
Planning, scaling, documenting, and executing human factors program activities in accordance with FDA guidance and other relevant international standards (e.g., IEC 62366, IEC 60601, ISO 14971)
Use-related Risk analysis
Designing usability studies and driving testing strategies
Moderating usability testing of prototypes with end users and customers
Aiding in data collection and root cause analysis during usability testing
Responsible for Use-related Risk Analysis documentation
Provide technical insight for user interface design, HF processes, and planning for team and business strategy
Perform observation / contextual inquiry for applicable use cases/environments e.g. Surgery
Moderate interviews with end users and customers for the purpose of need finding, use case identification, use condition identification, use error identification, validation of customer and user needs, and determining effectiveness of risk controls
Contribute and maintain human factors program documentation as needed for the Usability Engineering File
Aiding teams with preparation of usability-related documentation for regulatory body submissions
Aid in identifying use-related issues upon post-market launch and provide recommendations of risk control enhancements
Preferred
MS or higher (specific experience in medical device development is strongly preferred)
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
1001-5000 employees
H1B Sponsorship
Planet Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (3)
2021 (5)
2020 (5)
Funding
Current Stage
Late StageLeadership Team
Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
Emma Morris
President, PPG Advisory Partners
Company data provided by crunchbase