Ashby HQ is hiring a Clinical Scientist to join our Devices function. Our mission is to hasten the transition to universally accessible healthcare. You will be responsible for assessing and certifying innovative medical device software, conducting swift and accurate device assessments while providing knowledge to internal functions and external stakeholders.
What You'll Do
- Get authorized to assess the clinical evaluation processes of the most innovative medical devices in the world, focusing on clinical studies and clinical evidence.
- Collaborate with a multidisciplinary team on technical documentation assessments.
- Create content in areas like clinical AI, biostatistics, clinical research methodology, and real world evidence to educate teammates, customers, and prospects.
- Deploy your expertise externally by representing Scarlet at events and conferences.
- Screen and action regulatory insights from the latest research, standards, and guidance.
- Support the Sales and Customer Experience function by providing regulatory and scientific insights on prospects and customers.
- Work with our Product, Engineering, Design, and Applied ML functions to build and improve our systems.
- Support the Technical Operations function as they expand Scarlet’s approvals in various jurisdictions and technologies.
What We're Looking For
- A degree in clinical medicine, nursing, dentistry, epidemiology, or public health.
- Minimum of two years experience with the assessment of clinical data for medical devices.
- Experience developing, implementing, or evaluating medical device software.
- Knowledge of the fundamental principles of the assessment of clinical data for medical devices and medical statistics.
- Minimum of two years experience in patient care.
- Practical experience in conducting or monitoring clinical investigations/trials or assessing clinical data.
Nice to Have
- Ferociously curious—you like going down rabbit holes, understanding deeply how things work, and challenging the status quo.
- Excellent communicator with exceptional written and verbal communication skills.
- Highly adaptable—you have worked in different environments and like operating with autonomy on sometimes ambiguous tasks.
- Knowledge or training in relevant standards and guidance for clinical evaluation (e.g., ISO 14155, MEDDEV 2.7/1 Rev.4).
- Knowledge of different clinical research methodologies, including experience designing or contributing to the development of interventional and non-interventional clinical studies.
- Experience in the hands-on application of biostatistical methods in clinical research, or in the critical appraisal of statistical methodologies used in clinical studies and scientific literature.
- Strong technical knowledge of modern generative AI (e.g., LLMs, embeddings, RAG, fine-tuning, evaluation/monitoring) and a rich understanding of how these systems work—and fail.
Team & Environment
You will join the Devices function, a team of clinicians, AI experts, and software engineers.
Ashby HQ is an equal opportunity employer.
