Senior R&D Engineer Heart Valve Design & Development

Job Description

Job DescriptionExperience: 10+ years of experience in cardiovascular device development, with strong focus on heart valves

Location: Local candidates only (must live in Orange County)

Job Type: Full-time or Part-time (Flexible)

Salary: Competitive compensation based on experience and engagement structure (hourly, part-time, or full-time)

About Us


We are a growing medical device company focused on the design and development of advanced cardiovascular technologies. Our work centers on delivering high-quality, innovative solutions to support patient outcomes and meet rigorous regulatory standards.

Role Overview


We are seeking a Senior R&D Engineer with deep experience in heart valve design and development to support ongoing and new product initiatives. This role is ideal for someone who enjoys hands-on engineering, mentoring, and contributing meaningfully without the constraints of a traditional corporate structure.

Key Responsibilities

• Lead and support design and development of heart valve systems (surgical and/or transcatheter)
• Provide technical guidance across concept, prototyping, testing, and design verification
• Review and contribute to design documentation, risk analysis, and regulatory submissions
• Support troubleshooting, root cause analysis, and product improvements
• Collaborate with cross-functional teams (quality, regulatory, manufacturing)
• Mentor junior engineers and contribute to team capability building

Qualifications

• 10+ years of experience in cardiovascular device development, with strong focus on heart valves
• Proven track record in end-to-end product development
• Strong understanding of materials, hemodynamics, and durability testing
• Experience with FDA and/or EU regulatory requirements
• Ability to work independently and provide practical, solution-oriented guidance

What We Offer

• Flexible work arrangement (full-time or part-time based on mutual fit)
• Opportunity to make a direct impact on product development and company growth
• Lean, decision-driven environment minimal bureaucracy
• Competitive compensation based on experience and engagement level

How to Apply


Please send your resume and a brief note outlining your experience in heart valve development and preferred work arrangement

Flexible work from home options available.