Senior Clinical Scientist / Engineer

Position Summary

We are seeking a highly analytical and self-driven Sr. Clinical Scientist / Engineer to lead the development of high-quality scientific and technical documentation supporting our TMVR (Transcatheter Mitral Valve Replacement) system. This individual contributor role partners cross-functionally with Clinical, R&D, Regulatory, and Quality teams to transform complex clinical, engineering, and procedural insights into clear, accurate, and submission-ready materials.

This role is ideal for someone who thrives in a fast-paced environment, enjoys owning work end-to-end, and is passionate about advancing innovative structural heart technologies.

Key Responsibilities

Scientific Leadership & Analysis

• Develop deep subject matter expertise in company products and TMVR procedures
• Analyze clinical data, procedural learnings, engineering inputs, and scientific literature to support product development and continuous improvement
• Interpret anatomical, procedural, and clinical variables to generate scientifically sound insights

Technical Documentation & Medical Writing

• Lead the creation of clear, structured, and scientifically rigorous documentation for regulatory submissions and internal use
• Translate complex procedural and clinical information into accurate, accessible content
• Ensure all materials meet high standards for clarity, consistency, and scientific defensibility

Cross-Functional Collaboration

• Act as a central hub for collecting and synthesizing insights from Clinical, R&D, Regulatory, Quality, and Therapy Development teams
• Facilitate structured review cycles with subject matter experts to ensure alignment and accuracy
• Partner with stakeholders to validate assumptions and close knowledge gaps

Clinical & Procedural Support

• Support clinical cases by preparing devices and troubleshooting procedural issues as needed
• Incorporate physician feedback, imaging data, and real-world insights into documentation and analysis

Process Ownership

• Own end-to-end documentation workflows, including planning, drafting, review cycles, version control, and finalization
• Identify gaps or inconsistencies in data and proactively drive efforts to resolve them

Qualifications

Education

• Master’s degree in Biomedical Engineering, Life Sciences, or a related field

Experience

• 7+ years of experience in Clinical Science / Engineering, Clinical Affairs, Medical Writing, or Clinical Research within medical devices or cardiovascular space
• Experience with structural heart technologies (TMVR, TAVR, or other transcatheter systems preferred)
• Experience analyzing clinical data, procedural imaging, and physician feedback

Knowledge, Skills & Abilities

• Strong understanding of clinical trial design and execution
• Exceptional technical writing and communication skills
• Ability to synthesize complex data into clear, cohesive, and scientifically sound narratives
• Proven ability to independently manage projects from concept to completion
• Detail-oriented with a strong commitment to accuracy and scientific rigor
• Comfortable working in fast-paced, evolving, cross-functional environments
• Resourceful, curious, and proactive in identifying and solving problems
• Strong collaboration skills with the ability to build alignment across disciplines

What Success Looks Like

• High-quality, submission-ready documentation delivered on time
• Clear, actionable insights derived from complex clinical and procedural data
• Strong cross-functional alignment and trust as a scientific partner
• Continuous improvement in documentation quality and knowledge integration

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