Maxonic Inc.
Direct message the job poster from Maxonic Inc.
Maxonic maintains a close and long-term relationship with our direct client. In support of their needs, we are looking for a
Job Description:
Job Location: Sunnyvale, CA
Work Schedule: On-site
Rate: $59/hr, Based on experience.
Responsibilities
Minimum 5 years of experience. Skills: Risk analysis, usability engineering, design control process, tools - Polarion/Agile/Python/Smartsheets. Medical device background or regulated industry background is required and mandatory. As part of the Human Factors team, the Sr. Human Factors Design Controls Engineer works closely with HF team members and department leadership, clinical engineers, interaction designers, system and software engineers, product managers, project management and technical publications, regulatory and quality. Inform, guide development of, and maintain usability engineering documentation produced during projects within Design Controls. Implement summaries of known use problems, task analyses, risk analyses, design inputs and usability validation test cases in a comprehensive and timely manner. Provide expertise in design controls and content creation in Polarion and Agile, and help create usability engineering documentation for regulatory submissions. Support the broader human factors engineering team across all business units. Business Units
Digital Business Unit: Focus on user experience with software and web-based products integrated with Client products. ION System Business Unit: Supports development of systems, software, and instruments for pulmonary/endoluminal treatment modalities. Da Vinci Multiport RAS Business Unit: Supports robotic systems, instruments and accessories with emphasis on user interface, workflow and safety. Da Vinci Single Port RAS Business Unit: Supports new and sustaining product development for the Da Vinci SP platform in RAS areas. Roles and Responsibilities
Research: Define, release and maintain task analyses and comparative task analyses; maintain known use problem documentation. Design: Define, release and maintain usability-related risk documentation and design inputs; create and maintain tracing documentation. Test: Guide validation test case definitions and ensure tracing between task analyses, risks, design inputs and test cases. Analyze: Resolve tracing conflicts and design input orphans between risks and design inputs/risk controls. Sustain and Improve: Analyze on-market product complaints, update usability risk assessments, and escalate usability issues as needed. Regulatory and Process: Stay current with MDR regulations and best practices (IEC 62366, AAMI HE75, FDA guidance) and advise on process and regulatory improvements; support continuous improvement of usability engineering processes. Leadership: Lead usability risk analysis updates for Client products; represent the Human Factors Design Controls function on core project teams; coordinate across sub-systems; mentor junior engineers. Qualifications
Minimum Education: BS in Human Factors Engineering, Biomedical Science or Engineering, Systems Engineering, Quality Engineering, Information and Data Science, Cognitive Psychology, Computer Science with HCI emphasis, Human Centered Design, or related field. Minimum of 8 years of related experience with a bachelor’s degree. Excellent verbal communication and presentation skills in a highly structured environment using multiple channels (email, text, video conference, instant messaging). Experience with Digital project collaboration tools (e.g., Polarion, Agile, Python, Smartsheets). Ability to collaborate across groups and management levels to solve complex usability issues involving detailed risk analysis. Ability to travel internationally and domestically up to 15% to on-site locations if remote. About Maxonic
Since 2002 Maxonic has been at the forefront of connecting candidate strengths to client challenges. Our award winning, dedicated team of recruiting professionals are specialized by technology, are great listeners, and will seek to find a position that meets the long-term career needs of our candidates. We take pride in the over 10,000 candidates that we have placed, and the repeat business that we earn from our satisfied clients. Interested in Applying?
Please apply with your most current resume. Feel free to contact Lavanya Dommeti (lavanya.d@maxonic.com / (510) 613-4997) for more details. Note
Referrals increase your chances of interviewing at Maxonic Inc. by 2x
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Minimum 5 years of experience. Skills: Risk analysis, usability engineering, design control process, tools - Polarion/Agile/Python/Smartsheets. Medical device background or regulated industry background is required and mandatory. As part of the Human Factors team, the Sr. Human Factors Design Controls Engineer works closely with HF team members and department leadership, clinical engineers, interaction designers, system and software engineers, product managers, project management and technical publications, regulatory and quality. Inform, guide development of, and maintain usability engineering documentation produced during projects within Design Controls. Implement summaries of known use problems, task analyses, risk analyses, design inputs and usability validation test cases in a comprehensive and timely manner. Provide expertise in design controls and content creation in Polarion and Agile, and help create usability engineering documentation for regulatory submissions. Support the broader human factors engineering team across all business units. Business Units
Digital Business Unit: Focus on user experience with software and web-based products integrated with Client products. ION System Business Unit: Supports development of systems, software, and instruments for pulmonary/endoluminal treatment modalities. Da Vinci Multiport RAS Business Unit: Supports robotic systems, instruments and accessories with emphasis on user interface, workflow and safety. Da Vinci Single Port RAS Business Unit: Supports new and sustaining product development for the Da Vinci SP platform in RAS areas. Roles and Responsibilities
Research: Define, release and maintain task analyses and comparative task analyses; maintain known use problem documentation. Design: Define, release and maintain usability-related risk documentation and design inputs; create and maintain tracing documentation. Test: Guide validation test case definitions and ensure tracing between task analyses, risks, design inputs and test cases. Analyze: Resolve tracing conflicts and design input orphans between risks and design inputs/risk controls. Sustain and Improve: Analyze on-market product complaints, update usability risk assessments, and escalate usability issues as needed. Regulatory and Process: Stay current with MDR regulations and best practices (IEC 62366, AAMI HE75, FDA guidance) and advise on process and regulatory improvements; support continuous improvement of usability engineering processes. Leadership: Lead usability risk analysis updates for Client products; represent the Human Factors Design Controls function on core project teams; coordinate across sub-systems; mentor junior engineers. Qualifications
Minimum Education: BS in Human Factors Engineering, Biomedical Science or Engineering, Systems Engineering, Quality Engineering, Information and Data Science, Cognitive Psychology, Computer Science with HCI emphasis, Human Centered Design, or related field. Minimum of 8 years of related experience with a bachelor’s degree. Excellent verbal communication and presentation skills in a highly structured environment using multiple channels (email, text, video conference, instant messaging). Experience with Digital project collaboration tools (e.g., Polarion, Agile, Python, Smartsheets). Ability to collaborate across groups and management levels to solve complex usability issues involving detailed risk analysis. Ability to travel internationally and domestically up to 15% to on-site locations if remote. About Maxonic
Since 2002 Maxonic has been at the forefront of connecting candidate strengths to client challenges. Our award winning, dedicated team of recruiting professionals are specialized by technology, are great listeners, and will seek to find a position that meets the long-term career needs of our candidates. We take pride in the over 10,000 candidates that we have placed, and the repeat business that we earn from our satisfied clients. Interested in Applying?
Please apply with your most current resume. Feel free to contact Lavanya Dommeti (lavanya.d@maxonic.com / (510) 613-4997) for more details. Note
Referrals increase your chances of interviewing at Maxonic Inc. by 2x
#J-18808-Ljbffr