Product Design Control Specialist
RadformationHouston, Texas, United States
Posted October 15, 2025
140000 - 170000 USD year
Full Time
About the Company
Radformation offers a suite of FDA-cleared tools designed to streamline and enhance the treatment planning process. Their core products include ClearCheck for automated plan checking and documentation, ClearCalc for instant dose validation, EZFluence for 3D plan generation, AutoContour for AI-driven contouring, ChartCheck for real-time patient monitoring, and QuickCode for billing QA. Radformation's user-friendly solutions significantly increase quality, efficiency, and safety in medical treatment planning.
Job Description
Radformation is transforming cancer care by automating and standardizing radiation oncology workflows through its innovative software. They are seeking a Product Design Control Specialist to liaison between Product and Regulatory teams, ensuring DHF delivery and compliance. This role supports the mission to improve cancer treatment quality and efficiency, and requires collaboration with multiple internal and external stakeholders.
Requirements
- 5+ years of Quality Systems experience and Software as a Medical Device (SaMD) experience.
- 3+ years in a regulatory project management or technical role.
- Experience working in a regulated agile development environment.
- Familiarity with global medical device regulations (QSR/QMSR, MDD/CMDR/MDR).
- Experience with eQMS and ALM systems.
Benefits
- Competitive compensation
- Multiple high-quality medical plan options
- Short-term and long-term disability and supplementary life insurance
- 401(k) with employer match
- Annual reimbursement for professional memberships
- Conference attendance and continued learning opportunities
- Self-managed PTO
- Paid holidays
- Monthly internet stipend
- Home office setup stipend
- Fully remote work environment
