Usability Engineer (On-site)
About The Position
The Usability Engineer works with a multidisciplinary group of stakeholders to develop compelling medical-device products in accordance with applicable standards. The role partners with UX specialists, product managers, risk management, and quality management worldwide to support development and release of complex hardware and software products across interventional oncology. The successful candidate is expected to reside in Minneapolis and travel approximately 25% of the time. The position leads usability-engineering activities and documentation in collaboration with quality, risk-management, and validation stakeholders. It integrates human-factors expertise and user feedback into product design, conducts usability assessments and testing, and presents findings to stakeholders. The engineer also determines the appropriate level of usability support for projects and ensures external clinical experts are engaged and compensated in accordance with quality and compliance standards. The role leads project usability engineering under internal work instructions, ensures documentation complies with IEC 62366-1:2015, and represents usability engineering in audits. It also supports the UX process across product-development stages, improves methods and tools, and educates and supports colleagues as an internal subject-matter expert.
Requirements
- Bachelor's degree in engineering with a specialization in human factors or biomedical engineering, human-computer interaction, psychology, or a related field.
- At least 5 years of experience applying human factors, ergonomics, usability engineering, or human-computer interaction standards in product design.
- Excellent written and verbal communication skills in English.
- Must reside in Minneapolis and be able to meet an expected 25% travel requirement.
Nice To Haves
- Experience working on complex, enterprise products and ecosystems in regulated industries.
- Clinical and/or healthcare product knowledge.
- Familiarity with applicable usability-engineering standards for medical devices, including IEC 62366-1.
Responsibilities
- Realize usability-engineering activities and documentation in collaboration with quality, risk-management, and validation stakeholders.
- Integrate human-factors knowledge, subject-matter expertise, and user feedback into product development and design to support safety and overall performance.
- Conduct usability assessments and testing as required, and present findings to stakeholders.
- Assess and recommend the level of usability-engineering support required based on project scope and other factors.
- Ensure external clinical experts are engaged and compensated in accordance with quality and compliance standards.
- Lead project usability-engineering activities according to internal work instructions.
- Ensure documentation complies with IEC 62366-1:2015 and represent usability engineering in audits.
- Partner with peers to apply the UX process and embed UX in key stages of product development.
- Engage stakeholders to evolve methods and processes.
- Educate and support peers and other UX experts as an internal usability-engineering subject-matter expert.
- Develop and improve tools, templates, and work instructions.
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- 401(k) retirement plan
- Life insurance
- Long-term and short-term disability insurance
- Paid parking or public transportation
- Paid time off
- Paid sick and safe time
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What This Job Offers
Job Type
Full-time
Career Level
Senior
