Revolutionizing Medical Technology: Assessing and Certifying Medical Devices
At Scarlet, we bridge the gap between tomorrow's cutting-edge medical devices and the rigorous safety standards of today. Our team of innovators and safety experts work tirelessly to ensure that every device reaches the hands of patients without compromising patient safety.
Join Scarlet as a Software Safety Engineer and be part of the team that has already achieved the impressive goal of reducing certification times for AI-enabled medical devices from a year or more down to just months. Your role will be instrumental in advancing our standards and processes to help ensure that medical devices reach patients quickly and safely.
About the Role
As a Software Safety Engineer, you will play a crucial role in assessing and certifying medical device software. Your responsibilities will include reviewing software lifecycle processes and technical documentation submitted by our customers, screening and addressing regulatory insights from the latest research, standards, and guidance, and collaborating with our product, engineering, and applied machine learning teams to improve our systems. You will also assist in providing regulatory insights to prospects and customers and contribute to creating content that explains complex regulatory topics.
Responsibilities
Assess software lifecycle processes and technical documentation submitted by our customers.
Screen and action regulatory insights from the latest research, standards, and guidance.
Work with our product, engineering, and applied machine learning teams to improve our systems.
Work with our market access team to expand Scarlet's responsibility to new jurisdictions and certifications.
Create content to explain complex regulatory topics to customers and prospects.
Provide regulatory insights to prospects and customers.
Required Qualifications
A degree in computer science or a related discipline.
Four or more years of experience in medical device or other safety-critical product manufacturing, auditing, or research, including two or more years of experience developing safety-critical software.
Practical experience with software development fundamentals, including software development lifecycle processes, software verification and validation testing, software configuration management, and cybersecurity.
Exceptional written and verbal communication skills.
Preferred Qualifications
Knowledge or training in relevant standards and guidance for medical device software, such as IEC 62304 and IEC 81001-5-1.
Practical experience with generative AI, such as large language models (LLMs), embeddings, and fine-tuning, for evaluating and monitoring.
Interview Process
A 30-minute introductory call with Hann to discuss the role and expectations.
A 30-minute interview with one of our Software Safety Engineers to assess your technical skills and expertise.
A 1-hour technical task and interview with Hann to evaluate your problem-solving abilities and understanding of software development processes and cybersecurity.
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