What are the responsibilities and job description for the Human Factors Usability Engineer position at Zing Recruiting?
We are seeking an R&D Engineer with expertise in Usability and Human Factors to play a pivotal role in the design and development of medical devices. This role focuses on minimizing user-related errors by collaborating closely with design teams, leading testing initiatives, and producing usability-related regulatory documentation.
Responsibilities
- Serve as a subject matter expert on Human Factors and Usability in medical devices, with in-depth knowledge of IEC Usability standards, AAMI Human Factors standards, and FDA Human Factors guidelines.
- Prepare essential design control documentation, including Usability Engineering Files (UEF), Use Specifications, Task Analysis, and uFMEA.
- Lead the planning, development, and execution of usability testing to ensure optimal product performance and safety.
- Provide training, coaching, and guidance to internal teams regarding the integration of usability design controls into product development processes.
- Influence usability policies and best practices within the global organization to ensure alignment with industry standards.
- Collaborate with R&D engineers to conduct field research, case study observations, and apply insights to human interface requirements, concept selection, and usability validation.
- Work independently with minimal supervision and as part of a cross-functional team to drive product development forward.
- Maintain effective communication with global teams at various organizational levels.
- Ensure compliance with safety regulations and company quality standards.
- Regular and punctual attendance required.
Qualifications
- Bachelor’s degree in Engineering or a related field (preferred degrees: Human Factors, Mechanical, Biomedical, Design, or similar).
- At least 5 years of experience in Usability and Human Factors within medical device development.
- Proven experience conducting formative and summative studies required
- Expertise in user and use environment research, scenario development, and documentation.
- Proven ability to conduct and lead usability evaluations, including facilitation, observation, and supporting risk management efforts.
- Strong problem-solving skills with the ability to analyze complex issues effectively.
- In-depth knowledge of FDA 21CFR820, ISO 13485, IEC 62366-1, FDA Human Factors Guidance, and ISO 14971.
Job Summary
- Direct Hire
- Salary range: $100,000-$110,000/yr
- Full benefits package
This role offers the opportunity to significantly impact product development and ensure that user safety and usability are prioritized in the creation of innovative medical devices. If you are passionate about enhancing product safety through effective human factors engineering, we encourage you to apply! Qualified applicants will be contacted upon further resume review.
Zing Recruiting, a leader in the staffing industry for the past 33 years, continues our vision of ‘linking’ communities through employment. Zing’s dedication to the safety, health & well-being of our associates, clients and communities remains to be a #1 priority. Zing Recruiting is proud to be an EEOE, M/F/D/V, and we are committed to diversity both in practice and spirit at all levels of the organization. We encourage individuals with disabilities to apply for positions and will work to provide accommodation to those who need it. #ZINGMW
Salary : $100,000 - $110,000
