Senior Clinical Validation Engineer

Elucid; Boston (MA); On-site; USD 140,000 - 165,000; Full time

Job summary

Elucid, a Boston-based medical technology company, seeks a Senior Clinical Validation Engineer to lead SaMD validation for cardiovascular imaging software. You will guide validation for major system enhancements, ensure regulatory compliance, and drive cross-functional programs with a focus on quality outcomes.

You will collaborate with engineering, QA, and regulatory teams, translating complex medical concepts for stakeholders and enabling safe, effective solutions for clinicians.

Qualifications

• SaMD validation or clinical QA experience.
• Ability to translate technical concepts for diverse stakeholders.
• Guidance of cross-functional teams and risk-based decision making.
• Strong understanding of medical software systems and regulatory standards.

Responsibilities

• Lead validation for major system enhancements and new product launches.
• Oversee rigorous testing and documentation to ensure clinical performance and regulatory compliance.
• Drive cross-functional initiatives and serve as a subject matter expert.
• Collaborate with engineering, QA, and regulatory teams to deliver safe, effective cardiovascular imaging software.

Skills

Communication

Collaboration

Decision making

Regulatory knowledge

Startup experience

Education

Biomedical engineering degree

Advanced degree in related field

Tools

Jira

Job description

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!

As a Senior Clinical Validation Engineer, you’ll be at the forefront of advancing our AI-powered cardiovascular imaging software. In this role, you’ll lead validation for major system enhancements and new product launches, ensuring our software meets the highest standards of clinical performance and regulatory compliance. Leveraging your expertise in SaMD validation, medical device regulation, and cardiovascular imaging, you’ll drive cross-functional initiatives, oversee rigorous testing and documentation, and serve as a trusted subject matter expert. Your work will play a key role in delivering a safe, effective, and potentially life-saving solution empowering physicians and transforming patient care.

The ideal candidate will have:

• Degree in biomedical engineering 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, 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.
• Experience in a startup or small to mid-size organization preferred.

Work Location:

• This role is based out of our office in Boston, MA. 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.

Salary Range:

• The anticipated base salary range for this position at Elucid is $140,000 - $165,000. Compensation will be influenced by a wide array of factors including but not limited to internal pay equity, job-related knowledge, skills, education, relevant experience, certifications, and geography as outlined in the job description.

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!