Job Description

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 Technologist for 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+ years of hands-on experience in medical device manufacturing or prototyping.
• Direct experience with structural heart implants and/or steerable catheters .
• Advanced skills in micro-assembly and fine-detail precision 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 knowledge of Good Manufacturing Practices, ISO 13485, ISO 14971, and FDA QSR requirements.
• Proactive problem-solver able 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).

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