Regulatory Affairs Software Quality Engineer

Work at Radformation

Cancer rates increase year after year, yet high-quality care is not universal. By automating and standardizing the treatment planning workflow, Radformation aims to create a system where any patient anywhere can receive the same high-quality care.

We strive daily to reduce cancer's global impact and help save more of the 10 million lives it claims each year. Our unwavering commitment is to deliver reliable, high-quality, automated solutions that allow clinics to standardized care for every single person in need.

Regulatory Affairs Software Quality Engineer

Remote, US

Radformation creates solutions that detect medical errors and save clinical time for clinicians with a focus in radiation therapy. Using advanced algorithms and optimization techniques, our solutions bring automation to cancer treatments. Currently, many safety checks and planning steps are manually completed. Our goal is to help automate these processes for a more efficient and safer healthcare environment.

Our software focuses on three key areas:

1. Time savings through automation.

2. Error reduction through automated systems monitoring patient data for errors.

3. Increased quality care through advanced algorithms creating patient treatment plans that are improved from current manual methods.

Radformation is seeking an experienced Regulatory Affairs Software Quality Engineer to support the Regulatory and Quality teams with tool development, tool validation, automation and data analysis.

• 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.

• 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.

What makes us so RAD?

We take care of our people!

Radformation offers top-tier medical, dental, vision care for employees and their families. Each role comes with our 401(k) & employer match vest immediately and you'll never have to stress about taking the time you need with self-managed PTO. We support our growing RAD families with generous parental leave, along with additional part-time work to help transition back into the swing of things. We are a fully remote team and while we may be apart, virtual events, yearly retreats and a collaborative work environment keep us close and connected.

Cancer transcends any individual differences we may have. That's why at Radformation we celebrate diversity and are committed to creating an inclusive environment for all employees. We are proud to be an equal opportunity workplace and an affirmative action employer.