Clinical Validation Specialist

4 weeks ago

Boston, United States eLucid Full time

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 us as a Clinical Validation Engineer and play a crucial role in ensuring our medical device software meets the highest standards as part of our growing Clinical QA team. You'll design and execute innovative test strategies, meticulously document defects, and collaborate with top-tier software development teams to resolve issues. Your keen eye for detail will drive our products to clinical excellence. You'll also craft comprehensive validation plans and protocols, ensuring thorough reporting. Your work will uphold the integrity and reliability of our software, making a significant impact on a potentially lifesaving product.

*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:
  • Develop/execute product/process validation: design of experiments, operational qualification, performance qualification, and other process validation activities, to establish product/process performance.
  • Develop process/product monitoring and control activities based on validation results.
  • Develop design verification strategies and test plans with SQA to ensure clinical performance and correctness.
  • Act as a quality advocate on behalf of patient and physician needs within agile/scrum engineering teams to ensure standards are met and risks to patients are mitigated as necessary throughout the software development lifecycle.
  • Understand patient risks, objectives, responsibilities of the Clinical and SQA teams and work towards those goals.
  • Develop clinical specifications and acceptance criteria.
  • Document defects found during testing and troubleshoot issues.
  • Document test protocols and reports and maintain other related documents such as work instructions to ensure continuing clinical product performance.
Skills and Qualifications:
  • 4+ years of relevant software testing or clinical QA experience.
  • Excellent communication skills, both written and verbal, with an ability to translate technical context into mainstream language.
  • Adaptable, able to work in a scaling, fast-paced startup environment.
  • Strong experience using Jira.
  • Bonus: Prior experience working with medical imaging (CTA), medical devices or in a regulated industry.
  • Bonus: Knowledge of cardiovascular disease and anatomy.

Education and Certifications:

  • Degree in Radiology Technology, Computer Science, biomedical engineering or related field.

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At Elucid, we believe the optimal balance is found in a hybrid work setting. Boston-area employees are strongly encouraged to be in-person on Mondays and Wednesdays, with the option to come in as many days as theyd like. Fully remote employees, who live outside the greater Boston area, come in as needed.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

We know imposter syndrome and the confidence gap can get in the way of meeting great candidates. Even if you don't check every box, but see yourself contributing, please apply.

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