Sr. R&D Engineer

Our client is an innovative structural heart medical device company developing a first-in-class Transcatheter Mitral Valve Replacement (TMVR) technology designed to transform the treatment of mitral regurgitation.

They are seeking an experienced Research & Development Engineer who can bridge the gap between clinical procedures and product design. This highly visible role will focus on gathering physician and procedural feedback, analyzing device performance, identifying opportunities for improvement, and translating clinical learnings into engineering solutions that improve patient outcomes.

This is an ideal opportunity for an engineer who enjoys solving complex clinical and technical challenges while working directly with physicians, clinical teams, and cross-functional engineering groups.

Your role with the company:

As an R&D Engineer, you will play a critical role in evaluating real-world device performance and identifying opportunities to improve safety, effectiveness, usability, and scalability.

Key responsibilities include:

• Analyze product performance, procedural data, clinical outcomes, and anatomical information to identify trends and opportunities for improvement
• Gather and evaluate physician feedback, procedural observations, and device performance data
• Lead root cause investigations and develop structured processes to capture and analyze clinical learnings
• Translate physician and clinical feedback into actionable product requirements and engineering specifications
• Support design improvements that enhance device performance, ease of use, safety, and patient outcomes
• Collaborate with Clinical, Regulatory, Therapy Development, Quality, and R&D teams to drive continuous product improvement
• Conduct preclinical, simulated-use, usability, and Human Factors Engineering (HFE) activities
• Support test method development, fixture design, validation activities, and critical testing programs
• Contribute to risk assessments, technical documentation, and regulatory submissions
• Maintain awareness of competitive technologies, clinical literature, and advancements within structural heart therapies

Desired Profile:

Required Qualifications

• Bachelor's degree in Biomedical Engineering, Mechanical Engineering, or a related engineering discipline
• 5+ years of cardiovascular medical device R&D or product development experience
• Experience supporting Class III medical devices
• Strong analytical, troubleshooting, and problem-solving skills
• Ability to evaluate procedural feedback and convert observations into engineering solutions
• Experience working within cross-functional product development environments

Preferred Qualifications

• Structural heart experience
• Experience with nitinol-based devices or implantable cardiovascular technologies
• Experience in a startup or pre-commercial medical device environment
• Familiarity with Human Factors Engineering (HFE)
• Experience with fluoroscopy, echocardiography, and anatomical imaging analysis
• Proficiency with CAD tools such as SolidWorks or Pro/Engineer
• Experience with statistical analysis tools such as Minitab

Most R&D engineering roles focus on designing products.

This role focuses on making them better.

You'll have the opportunity to work directly with physicians and clinical teams to understand how a device performs during real-world procedures, identify opportunities for improvement, and drive solutions that can positively impact patient outcomes.