Experience: 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.