Job Description

Job Title: R&D Engineer - Cardiovascular Devices
Location: Irvine, CA

About Us:
Our client is a fast-growing medical device company focused on developing innovative technologies that address unmet needs in cardiovascular care. Their mission is to improve and extend the lives of patients with heart and vascular conditions through cutting-edge engineering and evidence-based solutions. We're looking for passionate innovators ready to make a lasting impact on global health.

Position Summary:
We are seeking a skilled and driven R&D Engineer to join their cardiovascular product development team. In this role, you'll contribute to the design, development, and testing of novel devices such as catheters, stents, implantable systems, and delivery tools. You'll be involved from concept through clinical validation and manufacturing transfer, collaborating closely with cross-functional teams.

Key Responsibilities:

• Lead or support design and development of cardiovascular devices in compliance with FDA and ISO standards.

• Develop prototypes and iterate designs based on bench, preclinical, and clinical testing feedback.

• Perform design verification and validation activities, including writing protocols and reports.

• Analyze failure modes and implement design improvements using FMEA and root cause analysis.

• Collaborate with clinicians to understand clinical needs and translate them into technical solutions.

• Interface with manufacturing, quality, and regulatory teams to ensure smooth design transfer and scalability.

• Maintain detailed design history files and support regulatory submissions with technical documentation.

Required Qualifications:

• Bachelor's or Master's degree in Biomedical, Mechanical, or related Engineering discipline.

• 2+ years of experience in R&D within the cardiovascular medical device industry.

• Hands-on experience with catheter-based technologies, stents, or implantable cardiac devices.

• Strong knowledge of design control practices, ISO 13485, and 21 CFR Part 820.

• Proficiency with CAD tools (e.g., SolidWorks) and familiarity with prototyping techniques.

• Excellent communication and collaboration skills.

Preferred Qualifications:

• Experience with balloon catheters, guidewires, or minimally invasive delivery systems.

• Knowledge of cardiovascular anatomy, physiology, and common procedural techniques.

• Familiarity with mechanical testing (e.g., burst, fatigue, trackability) and wet lab work.

• Exposure to clinical trials or interactions with physicians and KOLs.

Why Join Us?

• Work on life-saving technologies that make a real impact in the cardiovascular space.

• Join a collaborative, mission-driven team with a startup mindset and strong growth potential.

• Competitive compensation, comprehensive benefits, and opportunities for professional development.

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