Senior R&D Engineer - Implant/Clinical, Structural ...

Meacor Inc. Irvine, CA (Onsite)Meacor is pioneering the future of valvular repair with a truly novel transcatheter device that leverages groundbreaking on-demand cryoadhesion technology. We're not just improving existing solutions; we're building something fundamentally new to address critical patient needs. Fresh off a successful Series A funding round, we have the momentum and resources to accelerate development and bring this innovative platform to the clinical field. Located in the vibrant medical device hub of Irvine, California, our team thrives in a dynamic environment supported by robust in-house prototyping capabilities.The OpportunityMeacor is seeking a Senior R&D Engineer to develop and validate the next-generation mitral and tricuspid valve repair devices. You will be a core part of our team, focused on the development of the implant and its integration with the delivery system.In this hands-on position you will:· Define and execute design verification strategies and develop test procedures to ensure product requirements are met.· Drive the design and development of critical implant sub-components, including anchors, sutures, and cinching mechanisms.· Translate physician and clinical feedback into actionable engineering requirements.· Collaborate closely with R&D, clinical, and manufacturing teams, supporting product transfer into a cleanroom manufacturing environment.This role requires a balance of technical design expertise, clinical insight, and practical problem solving, along with the ability to foster strong relationships across teams and with physicians.Key ResponsibilitiesThis role is a senior individual contributor position with opportunities to lead project-level initiatives.· This role is a senior individual contributor position with opportunities to lead project-level initiatives.· Define and execute design verification strategies, including test methods, custom fixtures, and equipment.· Develop and maintain product specifications to ensure compliance with engineering requirements and clinical use cases.· Interpret medical imaging and collaborate with physicians to translate clinical insights into actionable engineering solutions.· Partner with manufacturing to establish scalable, reproducible processes and support transfer into a cleanroom environment.· Contribute to preclinical, regulatory, and clinical trial activities by supporting testing, documentation, and submissions in accordance with ISO 5840, ISO 5910, FDA, and EU MDR requirements.· Prepare high-quality technical documentation and communicate results to internal teams and external stakeholders.· Establish internal standards and inspection methods for components and final devices to ensure consistent quality.Required Skills & Qualifications· Bachelor of Science in Engineering required; advanced degree preferred.· 7+ years of engineering experience, including direct work with structural heart implants; annuloplasty experience strongly preferred.· Proficiency in CAD software (SolidWorks preferred) for 3D design and technical drawings.· Deep understanding of cardiac anatomy, clinical workflows, and imaging modalities (echocardiography, fluoroscopy); prior cath lab or physician interface experience desirable.· Hands-on experience with design, prototyping, and collaboration on manufacturing methods (3D printing, machining/lathe, laser welding) within a QMS.· Experience supporting regulatory submissions (FDA IDE/PMA, EU MDR) and contributing to pre-clinical or early clinical trial activities is highly desirable.· Familiarity with testing standards such as ISO 5840 and ISO 5910. · Working knowledge of statistical techniques such as design of experiments (DOE), tolerance analysis, and verification testing.· Strong documentation, communication, and interpersonal skills, with the ability to collaborate effectively across technical teams and with clinicians.Why Join Meacor?· At Meacor, you will be part of a team at the forefront of medical innovation, where your work has a direct impact on patients' lives. We foster a culture of creativity, collaboration, and technical excellence, giving you the resources and support to drive meaningful innovation. Our leadership team brings decades of collective experience in structural heart innovation, with a track record of successful startups, clinical trials, and product launches.· Contribute to the development of a first-in-class transcatheter device utilizing novel on-demand adhesion technology.· Reporting to a C-level executive, this is a hands-on senior individual contributor position with significant technical leadership. The role includes ownership of critical implant subsystems and the opportunity to mentor junior team members, driving projects from concept through verification and validation.· Work in a highly collaborative environment with state-of-the-art in-house prototyping and manufacturing capabilities for rapid iteration.· Engage directly with world-class clinicians to ensure our solutions address critical real-world patient needs.· Receive a competitive compensation package commensurate with experience, including a market-based salary ($130k-170k), equity participation, and comprehensive benefits (health, dental, vision, 401(k), and paid time off)

Created: 2025-10-02