Senior SaMD Validation Engineer - Cardiovascular AI

Elucid; Boston (MA); Hybrid; 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

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.