Senior R&D Heart Valve Engineer
Full Time • Hybrid - US
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.
Compensation: $40.00 - $130.00 per hour
Lives well bridged - Indeed!
We bridge lives by offering innovative & well thought out solutions to the medical device industry
We are the leading Contract Manufacturing Organization (CMO) in the transcatheter heart valve area. We custom produce Transcatheter Aortic Valve (TAVR), Transcatheter Mitral Valve (TMVR) and Transcatheter Tricuspid Valves as per client requirements based on their IP.
We are the leading Contract Manufacturing Organization (CMO) in the transcatheter heart valve area. We custom produce Transcatheter Aortic Valve (TAVR), Transcatheter Mitral Valve (TMVR) and Transcatheter Tricuspid Valves as per client requirements based on their IP.
We not only custom produce the valves from scratch ( tissue to valve), but also fill the gap as in-house consultants offering help in various areas like biocompatibility, ISO 22442, sterilization, viral inactivation qualification, QMS, regulatory submissions and FIH studies. Often times working with our partners we can help our clients with stent, delivery system & FIH clinical trials also.
We have the unique talent of manufacturing, consulting, and strategizing services in the area of medical devices, especially transcatheter heart valves. Our specialty is customizing the solutions required based on the device and not recommending the whole “nine yards” for any device, thus saving our clients’ time and resources.
Our talented associates work with your R&D, Regulatory, Quality, and Manufacturing divisions (or “teams”) to provide cost and time saving strategies, whether it is for simple biocompatibility testing or deep dive consulting on viral inactivation studies for class III medical devices. We come with an in-depth knowledge with many years of experience and offer customized solutions to each of our clients on an as needed basis with the utmost integrity.
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