Senior R&D Technologist

Company: Meacor Inc.-Irvine, CA (Onsite) About Meacor 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 Irvine, California’s medtech hub, we thrive in a dynamic, multidisciplinary environment with robust in-house prototyping and manufacturing capabilities. As a fast-paced, agile startup, we value hands-on expertise that directly accelerates life-changing technology to patients.The Opportunity We are seeking a Senior R&D Technologistfor a mission-critical, hands-on role. You will be central to advancing our device development from early prototyping and preclinical testing through First-in-Human trials. · Build and test complex prototypes that directly impact program milestones. · Work meticulously in a cleanroom environment with strong focus on documentation and quality. · Apply deep catheter manufacturing knowledge to translate designs into functional devices. Key Responsibilities Hands-on Prototyping:Directly fabricate, assemble, and test complex catheter and implantable prototypes for R&D and clinical use. Process Refinement:Apply your expertise in structural heart, steerable catheters, and implant manufacturing to refine device designs and assembly processes. Cleanroom Operations:Work in and maintain a controlled cleanroom environment, strictly adhering to all protocols, procedures, and gowning requirements. Documentation & Quality:Maintain accurate device history records (DHF/DHR) in compliance with ISO 13485, ISO 14971, and FDA QSR. Testing & Validation:Perform Verification and Validation (V&V) activities, including mechanical testing, visual inspections, and functional testing. Team Collaboration:Work closely with a multidisciplinary team of engineers, scientists, and clinicians in a fast-paced and collaborative setting.Required Qualifications & Skills 10+ yearsof hands-on experience in medical device manufacturing or prototyping. Direct experience withstructural heart implants and/or steerable catheters. Advanced skills inmicro-assembly and fine-detailprecision work. Proficiency with specialized equipment: Thermal Processing: lamination/reflow, tipping Joining & Bonding:laser welding, adhesive bonding, UV curing Fabrication:lathe, mill, and other basic machining for fixtures and prototypes Strong knowledgeof Good Manufacturing Practices, ISO 13485, ISO 14971, and FDA QSRrequirements. Proactive problem-solverable to thrive in a startup setting with shifting priorities. Excellent written and verbal communication skills. Education: BS in engineering or materials science preferred; equivalent experience considered.Why Join Meacor? This is a unique opportunity to be at the forefront of medical innovation. Your work will directly enable our device to enter clinical trials, helping to create a new standard of care for patients with valvular disease. Work in a highly collaborative environment with state-of-the-art in-house 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 ($90k-$120k), equity participation, and comprehensive benefits (health, dental, vision, 401(k), and paid time off).

Created: 2025-09-24