Akraya
Primary Skills: Risk analysis (Expert), Usability engineering (Expert), Design control process (Expert), Polarion (Proficient), Agile (Proficient)
Contract Type: W2 Only
Duration: 12+ Months
Location: Santa Clara, CA
Pay Range: $55 - $58 per hour on W2
Job Summary:
We are looking for a Senior Human Factors Design Controls Engineer to join our Human Factors team to contribute to the development and maintenance of usability engineering documentation within Design Controls for our medical device products. This role involves close collaboration with cross-functional teams to guide and support the production of crucial design documents and ensure compliance with global medical device regulatory standards. With a strong emphasis on risk analysis, usability engineering, and design control processes, the ideal candidate will play a pivotal role in advancing the world of minimally invasive care through intelligent technology and ingenuity.
Key Responsibilities:
Research and support the development and maintenance of task analyses, known use problem documentation, and Usability Engineering Plan documents. Design and maintain usability-related risk documentation, design inputs documentation, and traceability documentation ensuring comprehensive risk analysis and usability validation. Test and analyze by guiding best practices for validation test cases, ensuring appropriate tracing between task analysis, risks, design inputs, and test cases, and managing tracing conflicts effectively. Sustain and Improve by analyzing market product complaints, updating usability risk assessments, escalating usability issues, and staying updated with MDR regulations and human factors best practices. Collaborate by leading usability risk analysis efforts, representing the Human Factors Design Controls function in project core teams, coordinating human factors efforts across projects, and mentoring junior engineers in design control methods.
Must-Have Skills:
Expertise in Risk Analysis and Usability Engineering within a regulated industry. Proficient with tools such as Polarion and Agile. Strong communication and collaboration skills across various groups and levels of management.
Industry Experience:
A minimum of 8 years of experience in engineering, design controls, or medical device product development. Background in the medical device domain or a regulated industry is required and mandatory.
ABOUT AKRAYA Akraya is an award-winning IT staffing firm consistently recognized for our commitment to excellence and a thriving work environment. Most recently, we were recognized Inc's Best Workplaces 2024 and Silicon Valley's Best Places to Work by the San Francisco Business Journal (2024) and Glassdoor's Best Places to Work (2023 & 2022)! Industry Leaders in IT Staffing As staffing solutions providers for Fortune 100 companies, Akraya's industry recognitions solidify our leadership position in the IT staffing space. We don't just connect you with great jobs, we connect you with a workplace that inspires! Join Akraya Today! Let us lead you to your dream career and experience the Akraya difference. Browse our open positions and join our team!
Research and support the development and maintenance of task analyses, known use problem documentation, and Usability Engineering Plan documents. Design and maintain usability-related risk documentation, design inputs documentation, and traceability documentation ensuring comprehensive risk analysis and usability validation. Test and analyze by guiding best practices for validation test cases, ensuring appropriate tracing between task analysis, risks, design inputs, and test cases, and managing tracing conflicts effectively. Sustain and Improve by analyzing market product complaints, updating usability risk assessments, escalating usability issues, and staying updated with MDR regulations and human factors best practices. Collaborate by leading usability risk analysis efforts, representing the Human Factors Design Controls function in project core teams, coordinating human factors efforts across projects, and mentoring junior engineers in design control methods.
Must-Have Skills:
Expertise in Risk Analysis and Usability Engineering within a regulated industry. Proficient with tools such as Polarion and Agile. Strong communication and collaboration skills across various groups and levels of management.
Industry Experience:
A minimum of 8 years of experience in engineering, design controls, or medical device product development. Background in the medical device domain or a regulated industry is required and mandatory.
ABOUT AKRAYA Akraya is an award-winning IT staffing firm consistently recognized for our commitment to excellence and a thriving work environment. Most recently, we were recognized Inc's Best Workplaces 2024 and Silicon Valley's Best Places to Work by the San Francisco Business Journal (2024) and Glassdoor's Best Places to Work (2023 & 2022)! Industry Leaders in IT Staffing As staffing solutions providers for Fortune 100 companies, Akraya's industry recognitions solidify our leadership position in the IT staffing space. We don't just connect you with great jobs, we connect you with a workplace that inspires! Join Akraya Today! Let us lead you to your dream career and experience the Akraya difference. Browse our open positions and join our team!