Note: The job is a remote job and is open to candidates in USA. Elucid is a medical technology company using AI to help clinicians make informed decisions about cardiovascular care. The Senior Clinical Validation Engineer will lead validation for major system enhancements and product launches, ensuring clinical performance and regulatory compliance. The role also involves overseeing testing and documentation, driving cross-functional initiatives, and serving as a subject matter expert in SaMD validation, medical device regulation, and cardiovascular imaging.
Responsibilities
- Lead validation for major system enhancements and new product launches, ensuring our software meets the highest standards of clinical performance and regulatory compliance
- Leverage your expertise in SaMD validation, medical device regulation, and cardiovascular imaging
- Drive cross-functional initiatives, oversee rigorous testing and documentation, and serve as a trusted subject matter expert
Skills
- Degree in biomedical engineering or related field with 5+ years of SaMD validation or clinical QA experience
- Advanced degree in a related field with 2+ years of relevant experience
- Excellent communication, collaboration, and decision-making skills, with the ability to translate complex technical concepts into clear, accessible language and influence stakeholders across diverse teams and organizational levels
- Demonstrated ability to guide cross-functional teams, manage multiple complex projects, and make risk-based decisions to ensure high-quality outcomes in a fast-paced startup environment
- Strong understanding of medical software systems, applicable regulatory standards, and their integration into clinical workflows
- Prior experience working with with medical imaging (CTA), AI-enabled clinical software, or cardiovascular diagnostics
- Strong experience using Jira
- Knowledge of cardiovascular disease and anatomy
- This role is based out of our office in Boston, MA
- Candidates outside of the Boston area are invited to apply as fully-remote employees
- Experience in a startup or small to mid-size organization preferred
Benefits
- For local candidates, we operate in a hybrid model with regular in-office collaboration.
- Candidates outside of the Boston area are invited to apply as fully-remote employees.
- Boston-area employees are encouraged to work from the office on Mondays and Wednesdays, with the option to come in additional days if they prefer.
- Fully remote employees outside the Boston area come in as needed.
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