Senior Research And Development Engineer

MEACOR; Irvine (CA); On-site; USD 140,000 - 180,000; Full time

Benefits offered by this job

Equity options

401(k)

Health/dental benefits

Job summary

Meacor Inc. in Irvine, CA is seeking a Senior R&D Engineer to design and validate the next-generation mitral/tricuspid valve repair system, spanning implant and catheter delivery. You’ll influence performance and clinical outcomes with hands-on CFD?

no, with a focus on mechanical design, prototyping, and verification. The role emphasizes ISO 5840/5910, QMS compliance, and collaboration with firmware/electronics teams in a fast-paced startup-like environment.

Qualifications

• B.S. in Mechanical Engineering, Biomedical Engineering, or related discipline.
• 5–10 years in medical device R&D, with experience in structural heart, catheter delivery systems, or implantables.
• Strong CAD skills (SolidWorks preferred), hands-on fabrication, and proficiency in statistical analysis/DOE.
• Solid working knowledge of ISO 5840 / 5910 guidelines and operating within a regulated QMS.
• Startup mindset: hands-on, adaptable individual contributor in a fast-paced environment.
• Bonus: experience with sensors, energy-delivery systems, or embedded electronics in medical devices.

Responsibilities

• Design & Integration: Lead the mechanical design of implant sub-components and integrate into the catheter delivery system.
• Rapid Prototyping: Use in-house tooling (SolidWorks, 3D printing, machining, laser welding) to move concepts to prototypes.
• Testing & Verification: Design and execute DV testing and DOE studies to validate performance vs requirements.
• Clinical Translation: Translate clinical feedback and imaging data into engineering design improvements.
• Cross-Functional Collaboration: Partner with firmware/electronics engineers to validate system and console elements.
• Quality & Regulatory: Author docs, maintain QMS, and support FDA/EU MDR submissions.

Skills

CAD skills (SolidWorks)

Hands-on fabrication

DOE / statistical analysis

Engineering design

Cross-functional collaboration

Education

B.S. in Mechanical/Biomedical Eng

Tools

SolidWorks

3D printing

Machining

Laser welding

Job description

Company: Meacor Inc.

Location: Irvine, CA (Onsite)

Role Type: Full-time, Individual Contributor

Senior R&D Engineer – Implant & Catheter Systems

About Meacor

Meacor is pioneering a first-of-its-kind transcatheter device for structural heart repair, powered by novel on-demand cryoadhesion technology. We operate as a high-velocity, hands-on team backed by extensive in-house prototyping and manufacturing capabilities—enabling us to iterate rapidly from concept to clinical execution.

The Opportunity

We are seeking a Senior R&D Engineer to assist the design, development, and validation of our next-generation mitral and tricuspid valve repair system. This role spans both the implant and the delivery catheter, giving you direct influence over the performance and clinical outcomes of a life‑saving technology.

Key Responsibilities

• Design & Integration: Lead the mechanical design of implant sub‑components and seamlessly integrate them into the catheter delivery system.
• Rapid Prototyping: Utilize in‑house manufacturing tools (SolidWorks, 3D printing, machining, laser welding) to iterate rapidly from early concepts to cleanroom‑ready prototypes.
• Testing & Verification: Design and execute Design Verification (DV) testing and Design of Experiments (DOE) studies to validate system performance against regulatory standards and product requirements.
• Clinical Translation: Translate feedback from clinical advisors and medical imaging data (echo, fluoro) into concrete engineering design improvements.
• Cross‑Functional Collaboration: Partner with firmware and electronics engineers to validate system and console elements where applicable.
• Quality & Regulatory: Author technical documentation, maintain QMS standards, and support upcoming FDA and EU MDR regulatory submissions.

Qualifications

• Education: B.S. in Mechanical Engineering, Biomedical Engineering, or a related discipline.
• Experience: 5–10 years in medical device R&D, with direct experience in structural heart, catheter delivery systems, or implantables.
• Technical Proficiency: Strong CAD skills (SolidWorks preferred), hands‑on fabrication experience, and proficiency in statistical analysis/DOE.
• Standards & Compliance: Solid working knowledge of ISO 5840 / 5910 guidelines and operating within a regulated QMS.
• Startup Mindset: Comfortable operating as a hands‑on, highly adaptable individual contributor in a fast‑paced environment.
• Bonus Points: Experience with sensors, energy‑delivery systems, or embedded electronics in medical devices.

Why Meacor?

• High-Impact Work: Join on the ground floor of a truly novel therapeutic approach rather than incremental iteration.
• In‑House Capabilities: Access internal capabilities (laser welding, lathes, 3D printers, cleanroom and other equipment) for minimal downtime between design and testing.
• Direct Clinical Connection: Collaborate closely with leading clinicians to refine tools that directly impact patient outcomes.
• Competitive Package: Comprehensive salary range $140k-$180k, equity options, 401(k), and full health/dental benefits.