Senior Biomedical Engineer: Catheter & Ablation (Hybrid)

CyberCoders, Inc.; Emeryville (CA); Hybrid; USD 130.000 - 150.000; Vollzeit

Benefits dieser Stelle

$130K - $150K base salary

10% Bonus

Stock Options / Equity

401K with match

Health, Dental, Vision, LTD, and HSA

3 weeks PTO + 11 holidays

Zusammenfassung

CyberCoders, Inc. seeks a Senior Biomedical Engineer to lead design and development of minimally invasive therapeutic devices, focusing on catheter-based and ablation technologies. You will drive projects from concept through verification, validation, regulatory submission, and design transfer to manufacturing.

Join a small, scrappy team in a hybrid Emeryville environment, onsite Tue-Thu, with opportunity to mentor juniors and shape product strategy while navigating FDA pathways.

Qualifikationen

• Bachelor's degree in Biomedical Engineering, Mechanical Engineering, or related field; Master’s or PhD preferred.
• 7+ years of experience in medical device R&D with catheter-based or ablation products.
• Hands-on CAD, mechanical design, and rapid prototyping experience.
• Experience with design verification/validation and test protocol development.
• Experience preparing regulatory submissions and FDA interactions (510(k)/PMA).
• Knowledge of DHF, design controls, and Design Transfer to manufacturing.

Aufgaben

• Lead end-to-end development for catheter and ablation systems from concept to manufacturing transfer.
• Create CAD models and manufacturing drawings; support rapid prototyping and bench testing.
• Plan and execute design verification and design validation testing; document results.
• Develop and maintain DHF and ensure ISO 13485 compliant documentation.
• Prepare regulatory submission documents; liaise with regulatory affairs for FDA submissions.
• Lead design transfer and collaborate with manufacturing, quality, and suppliers.
• Support preclinical and clinical teams with design improvements.
• Conduct risk management (FMEA) and implement mitigation strategies.

Kenntnisse

CAD (SolidWorks)

Design verification

Design validation

FMEA

Regulatory submissions

DHF / design control

Leadership

Cross-functional teamwork

Ausbildung

Bachelor's degree in Biomedical Engineering or Mechanical Engineering

Master's or PhD preferred

Tools

SolidWorks

Jobbeschreibung

CyberCoders, Inc. seeks a Senior Biomedical Engineer to lead design and development of minimally invasive therapeutic devices, focusing on catheter-based and ablation technologies. You will drive projects from concept through verification, validation, regulatory submission, and design transfer to manufacturing.

Join a small, scrappy team in a hybrid Emeryville environment, onsite Tue-Thu, with opportunity to mentor juniors and shape product strategy while navigating FDA pathways.