Remote Regulatory Affairs Software Quality Engineer bei Radformation
Radformation · Vereinigte Staaten Von Amerika · Remote
- Professional
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.
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.
Knowledge, Skills and Abilities
· 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.
Required Experience
· >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.
Preferred Experience
· 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
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