
Senior Backend Engineer IRC272809
- Львов
- Постоянная работа
- Полная занятость
- BS/MS in Human Factors, or in a science/engineering discipline with relevant experience.
- 3+ years of Human Factors experience in design-controlled processes, specifically in regulated domains like medical devices.
- Must understand regulatory requirements, possess strong knowledge of medical device design and FDA guidelines, and be familiar with HE75 and IEC 62366-1, -2.
- Cross-functional experience in risk management activities, including FMEA expertise.
- Proficient in leading Human Factors processes, including study design, moderation, and execution.
- Skilled in deriving conclusions from study data and conducting effective root cause analyses.
- Demonstration of exceptional technical problem-solving, interpersonal, and communication skills (verbal and written).
- Available for up to 25% travel, including both domestic and international trips (must be cleared for international travel).
- Note: As part of your interview process, you may be asked to provide an example of HF documentation you have produced for an approved/released product.
- Strategize, execute, and document usability engineering evaluations, including task analyses and human factors studies.
- Author formative and summative usability study protocols
- Plan, coordinate, and moderate formative and summative usability studies.
- Perform root cause analysis of use errors and aggregate data for presentations and formal reports.
- Author and update usability risk analyses in collaboration with cross-functional stakeholders.
- Collaborate with Verification & Validation (V&V) teams during Design Validation and Summative Human Factors Validation.
- Partner with Quality teams to address complaints related to usability on-market products.
- Work with design teams to create patient-centric and compliant designs.
- Assist in developing usability engineering processes for Quality system improvements.
- Support inquiries, audits, and discussions with regulatory agencies.