Biomedical Engineer: Catheter Design & Regulatory Lead

CyberCoders, Inc.; Oakland (CA); Hybrid; USD 90,000 - 140,000; Full time

Benefits offered by this job

Performance Bonus

Equity

401K with match

Health, Dental, Vision, LTD, and HSA

3 weeks PTO + 11 holidays

Job summary

CyberCoders, Inc. is seeking a Biomedical Engineer to drive design, development, and regulatory readiness for novel medical devices, focusing on thermal ablation catheter systems.

You will lead R&D from concept through prototyping, verification/validation, and support GLP preclinical studies and early clinical trials in a hybrid Oakland-based role. The role blends hands-on CAD, prototyping, and testing with documentation and regulatory coordination to ensure safe, compliant, and manufacturable

Qualifications

• 3+ years in medical device development, preferably catheter systems.
• Proficiency in CAD and hands-on prototyping/testing.
• Experience preparing DHF/design files for regulatory submissions.
• Knowledge of FDA 21 CFR 820, ISO 13485, ISO 14971.
• Experience with GLP preclinical studies and early clinical trials.
• Familiarity with ISO 10993 and ISO 11135.
• Experience with supplier management and design transfer to manufacturing.

Responsibilities

• Lead design and development of catheter-based devices (RF, microwave, cryo, thermal ablation).
• Create and iterate CAD models and drawings; support prototyping and manufacturing transfer.
• Plan and execute engineering tests, bench evaluations, and design verification studies.
• Maintain DHF and regulatory documentation; support regulatory submissions.
• Coordinate with QA/Regulatory on compliance with standards and regs.

Skills

Analytical Thinking

Problem Solving

Written & Verbal Communication

Team Collaboration

Regulatory Awareness

Education

Bachelor's or Master’s in Biomedical/Mechanical Eng.

Tools

SolidWorks

Job description

CyberCoders, Inc. is seeking a Biomedical Engineer to drive design, development, and regulatory readiness for novel medical devices, focusing on thermal ablation catheter systems.

You will lead R&D from concept through prototyping, verification/validation, and support GLP preclinical studies and early clinical trials in a hybrid Oakland-based role. The role blends hands-on CAD, prototyping, and testing with documentation and regulatory coordination to ensure safe, compliant, and manufacturable