Senior-Principal R&D Engineer

Pleasanton, CA (On-site/local - travel may be okay)

We are seeking a hands-on, innovative R&D Engineer to join our team focused on advancing next-generation heart valve technologies. This role involves leading design and development activities, contributing to preclinical animal testing, and supporting clinical studies. The ideal candidate thrives in a collaborative environment, combines technical creativity with practical problem-solving, and brings direct experience in medical device testing and evaluation.

Key Responsibilities:

• Lead the design, prototyping, and refinement of valve repair delivery systems and handle mechanisms
• Drive durability, fatigue, and performance testing, including test method development and data analysis
• Support and oversee preclinical (animal) studies, ensuring compliance with approved protocols and regulatory requirements
• Collaborate closely with cross-functional teams (Quality, Clinical, Regulatory, Manufacturing) to translate concepts into clinically viable products
• Participate in and support clinical studies, including preparation, in-procedure support, and post-study data analysis
• Identify and implement innovative approaches to improve device performance, usability, and reliability

Qualifications:

• Proven experience in cardiovascular device development; valve technology experience required (tricuspid preferred)
• Strong background in delivery system and catheter-based device design
• Hands-on engineering experience from concept through prototype, testing, and iteration
• Experience conducting and supporting animal studies and contributing to clinical research activities
• Demonstrated experience with durability, fatigue, or lifecycle testing of Class III medical devices
• Strong problem-solving skills and ability to thrive in a fast-paced, collaborative R&D environment