Senior R&D Engineer – Heart Valve Design & Development
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AI Summary
Lead and support the design and development of heart valve systems while providing technical guidance throughout the product lifecycle. Collaborate with cross-functional teams and mentor junior engineers to ensure high-quality, regulatory-compliant product outcomes.
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)
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.
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