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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in human factors engineering principles and regulatory guidelines to enhance the safety and usability of medical devices. Proficient in planning and executing user studies, integrating user needs into design processes, and collaborating with cross-functional teams.
Highest-signal resume keywords
Human Factors EngineeringUsability TestingRegulatory Guidelines (IEC 62366, FDA)Risk AssessmentCross-Functional Collaboration
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Human-Centred DesignUser Studies PlanningDesign ValidationRisk Assessment IntegrationUsability Testing
Soft Skills
Strong Communication SkillsRelationship Management
Industry Keywords
Medical Device DevelopmentCombination Product DevelopmentUser Needs IntegrationDesign and Regulatory Challenges
About the role
Key responsibilities & impact- Lead human-centred design activities throughout all stages of device development to ensure products meet user needs.
- Plan and execute user studies, including early handling tests and design validation.
- Conduct user-related risk assessments and integrate findings into design decisions to improve safety and usability.
- Work with engineering, regulatory, clinical, and quality teams to solve design and regulatory challenges.
- Manage relationships and communications with external vendors and internal stakeholders.
- Prepare human factors and usability sections of regulatory documentation.
Requirements
What you’ll need- Degree in Mechanical Engineering, Biomedical Engineering, Human Factors, or a related field.
- Proven experience applying human factors engineering principles in medical device or combination product development.
- Understanding of human factors regulatory guidelines such as IEC 62366 and FDA usability requirements.
- Experience planning and conducting human factors studies, including usability testing and risk assessments.
- Knowledge of integrating user needs and risk information into design and validation activities.
- Strong communication skills to work effectively within cross-functional teams and with external partners.
- Occasional travel may be required.
Benefits
Comp & perks- Flexible hybrid working arrangement
- Agile working culture and flexibility opportunities
- Equal opportunity employment
- Reasonable adjustments and recruitment-process support
