About the Role
The position involves analyzing business and system requirements for medical device applications, ensuring alignment with regulatory standards and supporting cross-functional teams in delivering compliant, user-centered solutions.
Responsibilities
- Gather and document business and technical requirements for medical device software systems
- Collaborate with engineering, quality, and regulatory teams during product development
- Translate user needs into functional system specifications
- Support validation and verification processes for medical device applications
- Analyze workflows to improve system efficiency and usability
- Ensure compliance with FDA and ISO standards for medical devices
- Facilitate meetings between technical and non-technical stakeholders
- Develop use cases, process flows, and system models
- Track and manage requirements throughout the development lifecycle
- Assist in risk assessment and mitigation planning
- Review design documentation for regulatory alignment
- Conduct gap analysis between current and desired system capabilities
- Support integration of software systems with medical hardware
- Prepare test plans and coordinate user acceptance testing
- Maintain traceability matrices for regulatory submissions
- Identify opportunities for process automation
- Work within Agile development environments
- Provide input on user interface design for clinical applications
- Assist in post-market surveillance data analysis
- Ensure data privacy and security standards are met
- Coordinate with external vendors and partners
- Report on project status and deliverables
- Support quality management system audits
- Update documentation in line with change control procedures
- Promote best practices in systems analysis and regulatory compliance
Compensation
Competitive salary and benefits package
Work Arrangement
Remote, Continental United States
Team
Cross-functional team supporting healthcare technology projects
Why Join Us
- Opportunity to work on innovative medical technologies impacting patient care
- Flexible remote work environment within the continental U.S.
- Exposure to diverse healthcare projects and regulatory challenges
- Professional growth in a specialized technology domain
- Supportive team culture focused on collaboration and learning
Security Clearance
U.S. person status required due to regulatory and project requirements
