Regulatory Affairs Software Quality Engineer

Summary

Join Radformation, a company creating solutions to detect medical errors and save clinical time in radiation therapy, as an experienced Regulatory Affairs Software Quality Engineer. You will support the Regulatory and Quality teams in tool development, validation, automation, and data analysis. Radformation's software focuses on time savings, error reduction, and increased quality care through automation and advanced algorithms. This role requires significant experience in medical device product development, quality engineering, or quality systems management, along with advanced computer skills and experience with software tool validation. The position offers a competitive salary and benefits package, including immediate health/vision/dental insurance, generous paid time off, and a remote work environment. The ideal candidate will possess strong analytical, problem-solving, and communication skills and be comfortable working independently and as part of a team.

Requirements

• Excellent command of the English language (written and oral)
• Experience in Medical Device Product Development, Quality Engineering or Quality Systems Management
• Exceptional interpersonal skills to work effectively in a team environment
• Advanced computer skills including ability to program in Python, JavaScript, C#
• Strong organizational, time management, and planning skills
• Capable of working independently and exercising independent judgment
• Excellent analytical, investigative and problem-solving skills
• Experience with Quality System Management, Development and Improvement
• >4 years of experience in related roles with a Bachelor's degree; >2 years with Master's degree
• Experience with Non-Product Software Tool Validation
• Ability to generate test cases from product requirements
• Ability to develop SW tools using appropriate programming languages
• Familiarity with global medical device regulations
• Experience with data aggregation, analysis and trending
• Experience with KPI tracking and dashboarding
• Demonstrated ability to work productively in a remote environment

Responsibilities

• Validate 3rd party and internally developed tools
• Create custom tools for internal use
• Automate the collection, analysis, trending, and reporting/dashboarding of regulatory/cyber data
• Create custom forms and scripts related to our QMS and ALM application
• Update Software / Cyber Related Documentation as required for agency submissions

Preferred Qualifications

• Experience with DICOM formats and validation
• Experience with Radiation Oncology, technology, standards, workflows and terms
• Software as a medical device (SaMD) experience highly preferred
• Product development experience highly preferred
• Experience conducting FMEA, FMECA or FTA activities

Benefits

• Competitive salary
• Immediate Health/Vision/Dental insurance
• Generous Paid Time Off
• Remote Work Environment