Senior Clinical Validation Engineer
Boston, MA
Full Time
Mid Level
We are a rapidly growing, Boston-based medical technology company using AI to enable clinicians to make informed decisions on cardiovascular care - leading to better patient outcomes, improved quality of care, and reduced healthcare costs. Come work at Elucid and be part of delivering on our mission to prevent heart attacks and strokes.
Join our growing Clinical QA team ensuring our medical device software meets the highest standards of clinical accuracy and regulatory compliance! Our CQA team collaborates across software development, quality, clinical and regulatory teams, acting as quality advocate on behalf of patient and physician needs throughout the software development lifecycle.
As Senior Clinical Validation Engineer, you'll lead validation activities for our AI-powered medical imaging software, including comprehensive testing and documentation development. The ideal candidate brings experience in clinical validation of SaMD products, strong knowledge of medical device regulations, and familiarity with cardiovascular imaging. Working closely with cross-functional teams, your work will uphold the safety and effectiveness of our application, supporting the delivery of a potentially life-saving product to providers and patients.
Key Responsibilities:
Join our growing Clinical QA team ensuring our medical device software meets the highest standards of clinical accuracy and regulatory compliance! Our CQA team collaborates across software development, quality, clinical and regulatory teams, acting as quality advocate on behalf of patient and physician needs throughout the software development lifecycle.
As Senior Clinical Validation Engineer, you'll lead validation activities for our AI-powered medical imaging software, including comprehensive testing and documentation development. The ideal candidate brings experience in clinical validation of SaMD products, strong knowledge of medical device regulations, and familiarity with cardiovascular imaging. Working closely with cross-functional teams, your work will uphold the safety and effectiveness of our application, supporting the delivery of a potentially life-saving product to providers and patients.
* While candidates in the Boston, MA area are preferred, we are accepting applications from candidates in the continental US with a strong preference for eastern time zones. *
Key Responsibilities:
- Lead the planning, execution, and documentation of validation activities for our SaMD products, including: Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Establish validation strategies for new products and features, considering both regulatory compliance and business objectives.
- Perform validation testing and data analysis, troubleshooting and resolving issues and ensuring accurate documentation and reporting.
- Conduct risk assessments and failure mode analyses to identify potential validation issues.
- Participate in regulatory audits and inspections, serving as a subject matter expert for validation-related queries.
- Collaborate with software development teams, CQA and SQA teams to ensure validation requirements are incorporated into the development lifecycle.
- Continuously assess and improve validation documentation and processes.
- Mentor junior validation engineers and provide technical leadership in validation methodologies.
- Degree in biomedical engineering, radiology technology, computer science or related field with 5+ years of SaMD validation or clinical QA experience. or,
- Advanced degree in a related field with 2+ years of relevant experience.
- Excellent communication skills, both written and verbal, with an ability to translate technical context into mainstream language and collaborate across a diverse set of stakeholders.
- Adaptable, able to work in a scaling, fast-paced startup environment and comfortable with changing priorities and ambiguity.
- Strong understanding of medical software systems and their integration into clinical workflows.
- Strong experience using Jira.
- Prior experience working with medical imaging (CTA), medical devices or in a regulated industry.
- Knowledge of cardiovascular disease and anatomy.
- Experience in a startup or small to mid-size organization preferred.
- Occasional travel may be required.
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At Elucid, we believe the best work happens in a flexible hybrid environment. 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.
We are an equal opportunity employer and value diversity at Elucid. We do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability.
We understand that self-doubt can sometimes prevent great candidates from applying. If you believe you can make an impact at Elucid, even if you don’t meet every qualification, we encourage you to apply!
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