[Remote] Human Factors Engineer - Medical Devices
Note: The job is a remote job and is open to candidates in USA. Concord is an execution company focused on enhancing customer experiences and optimizing operations through technology and data. They are seeking a Human Factors Engineer to redefine user interface and product design in the healthcare industry, working with a global team to ensure patient-centric experiences across medical devices.
Responsibilities
- Serve as the voice of patients and end users in all product-related discussions
- Analyze user profiles, tasks, hazard-related use scenarios, usability risks, requirements, and HF-related V&V
- Create medical device usability deliverables in accordance with IEC 62366, IEC 62304, and FDA guidance on Human Factors Engineering
- Plan and execute formative and summative usability studies; coordinate external suppliers as needed
- Prepare, maintain, and review Usability Engineering Files for multiple products
- Advocate for safety, efficacy, accessibility, quality, and usability for end users
- Provide guidance and mentorship on Human Factors Engineering practices to other design team members throughout the product design and development process
Skills
- Must be authorized to work legally in the US without sponsorship, now or in the future
- 5+ years of experience in applied Human Factors Engineering and Design Control Management
- Master's degree in Science, Industrial Engineering, Human Factors Engineering, or a related technical field
- Experience with the Usability Engineering process for medical devices
- Proven ability to plan, execute, and document usability studies in a medical context
- Solid knowledge of ISO 14971, IEC 62304, and IEC 62366
- Experience in collecting and analyzing physiological and behavioral data
- Excellent communication and presentation skills
- Fluency in English required
- Experience creating, facilitating, and analyzing workshops with end users and engineers is a strong plus
- Knowledge or background in UX or UI design is a plus
- Additional languages are a plus
Benefits
- Health, Dental, and Vision Insurance - Comprehensive coverage to support your overall well-being.
- Employer Contributions to Health Savings Accounts (HSA) - For employees enrolled in High Deductible Health Plans, Concord contributes toward your HSA.
- Flexible Spending Accounts (FSA) - Options for healthcare and dependent care expenses, plus a Lifestyle Spending Account (LSA) for wellness and personal development.
- Disability Insurance - Short-term (up to 12 weeks) and long-term coverage, fully paid by the employer.
- Life and AD&D Insurance - Employer-provided coverage of with options for additional voluntary coverage.
- Employee Assistance Program (EAP) - Support for legal, financial, and personal challenges.
- 401(k) Retirement Savings - 1% employer match.
- Career Growth Opportunities - Pathways for advancement and skill development.
- Team Engagement Activities - Regular team-building events and company-sponsored activities to foster collaboration and connection.
Company Overview