Bachelor's degree in Biomedical Engineering, Mechanical Engineering, or related field.
5+ years of experience in the medical device industry, preferably in clinical development.
Strong understanding of medical robotics and transcatheter structural heart procedures.
Proficiency in DICOM analysis software.
Excellent analytical and problem-solving skills.
Strong communication and interpersonal skills.
Knowledge of regulatory requirements, especially FDA guidelines, is a plus.
Responsibilities
Collaborate with cross-functional teams to design and refine medical robotics systems.
Conduct pre-clinical evaluations to validate safety and performance of technology.
Support clinical trials by implementing and ensuring compliance for data collection processes.
Analyze clinical data to identify trends and potential areas for improvement.
Gather feedback from healthcare professionals for product refinement.
Stay updated on advancements in medical robotics and applied practices for improvements.
Assist in preparing technical documentation and presentations.
Benefits
Comprehensive medical, dental, and vision coverage at 100% for you and your family.
Flexible time off (flex time off).
Fun, collaborative environment focused on transformational technologies.
Opportunities for outdoor activities and office outings.
Full Job Description
Hiring Manager: Manager of Clinical Development
Description:
We are seeking a highly skilled and motivated Senior Clinical Development Engineer to join our team. As a Clinical Development Engineer, you will play a crucial role in the design, development, and implementation of Capstan Medical's medical robotics technology for transcatheter structural heart procedures. This role offers an exciting opportunity to contribute to groundbreaking advancements in minimally invasive cardiac interventions and make a significant impact on patient care.
Responsibilities
Collaborate with cross-functional teams to design, test, and refine medical robotics systems for transcatheter structural heart procedures.
Conduct pre-clinical evaluations and assessments to validate the safety, efficacy, and performance of Capstan Medical's technology.
Collaborate with clinical field team to model Support clinical trials by implementing and monitoring data collection processes, ensuring compliance with regulatory requirements and ethical standards.
Analyze and interpret clinical data to identify trends, insights, and potential areas for improvement.
Collaborate with physicians, surgeons, and other healthcare professionals to gather feedback and insights for product refinement.
Stay up-to-date with the latest advancements and best practices in medical robotics and transcatheter structural heart procedures, and apply this knowledge to enhance Capstan Medical's technology.
Assist in the preparation of technical documentation, including reports, publications, and presentations.
Skills
Strong understanding of medical robotics and transcatheter structural heart procedures, with a focus on minimally invasive interventions.
Proficiency in DICOM analysis software.
Excellent analytical and problem-solving skills, with the ability to interpret complex data sets.
Strong communication and interpersonal skills to effectively collaborate with cross-functional teams, healthcare professionals, and stakeholders.
Ability to work independently, manage multiple tasks simultaneously, and thrive in a fast-paced environment.
Knowledge of regulatory requirements, including FDA guidelines for medical device development, is a plus.
Requirements
Bachelor's degree in Biomedical Engineering, Mechanical Engineering, or a related field.
5+ years of experience in the medical device industry, particularly in clinical development, is highly desirable.
Why join us:
We offer a fun, fast-paced, collaborative environment where you will be working on transformational technologies in the cardiac healthcare space that can make a meaningful impact for patients
We offer outstanding benefits with medical, dental, and vision covered at 100% for you and your family, as well as flex time off
We thrive in our work-hard, play-hard environment. Bring your bike or running shoes if you'd like or just be ready to enjoy a fun office outing. We enjoy time inside the office and out!
