Senior Biomedical Engineer

CyberCoders, Inc.; Emeryville (CA); On-site; USD 130,000 - 150,000; Full time

Benefits offered by this job

$130K - $150K base salary

10% Bonus

Stock Options / Equity

401K with match

Health, Dental, Vision, LTD, and HSA

3 weeks PTO + 11 holidays

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

CAD (SolidWorks)

Design verification

Design validation

FMEA

Regulatory submissions

DHF / design control

Leadership

Cross-functional teamwork

Education

Bachelor's degree in Biomedical Engineering or Mechanical Engineering

Master's or PhD preferred

Tools

SolidWorks

Job description

Senior Biomedical Engineer

Position Overview

We are seeking a Senior Biomedical Engineer to lead design and development of minimally invasive therapeutic devices with a focus on catheter-based and ablation technologies. The role will drive R&D projects from concept through verification, validation, regulatory submission, and design transfer to manufacturing while supporting preclinical and clinical activities. The ideal candidate combines deep device engineering experience, hands‑on prototyping and CAD skills, and demonstrated success navigating FDA regulatory pathways.

Come join a small, scrappy team that is building revolutionary medical device products. This is a hyrbid role in Emeryville (onsite Tue-Thurs).

Key Responsibilities

• Lead end-to-end product development for catheter and ablation systems, including concept generation, detailed design, prototyping, and iterative refinement.
• Create and maintain CAD models and manufacturing-ready drawings using SolidWorks and other CAD tools; support rapid prototyping and bench testing.
• Plan, execute, and interpret engineering testing, design verification, and design validation activities; author and review test protocols and reports.
• Develop and maintain Design History Files (DHF) and ensure compliant documentation practices in accordance with QMS and ISO 13485 requirements.
• Prepare technical documentation for regulatory submissions (e.g., 510(k), PMA), interact with regulatory affairs to support FDA submissions and respond to agency questions.
• Lead design transfer and manufacturing handoff activities, working closely with manufacturing, quality, and suppliers to ensure smooth scale-up and product launch.
• Collaborate with preclinical and clinical teams to support animal studies and clinical trials, translating findings into design improvements.
• Perform risk management activities (e.g., FMEA) and implement mitigation strategies to meet safety and performance requirements.
• Mentor and coach junior engineers, foster cross-functional collaboration with R&D, regulatory, quality, and clinical teams, and contribute to project planning and scheduling.
• Stay current on industry trends and emerging technologies in thermal ablation, catheter design, and related fields to inform product strategy.

Qualifications

• Bachelor's degree in Biomedical Engineering, Mechanical Engineering, or related field required; Master's or PhD preferred.
• 7+ years of experience in medical device R&D, with a proven track record delivering catheter-based or ablation products to market.
• Hands‑on experience with CAD (SolidWorks preferred), mechanical design, and rapid prototyping techniques.
• Proven expertise in engineering testing, design verification and validation, and test protocol development.
• Experience preparing regulatory submissions and working with the FDA; familiarity with 510(k) and/or PMA pathways.
• Experience creating and maintaining Design History Files (DHF), design control documentation, and participating in Design Transfer and manufacturing handoff.
• Background supporting preclinical trials and clinical trials for implantable or minimally invasive devices.
• Knowledge of thermal ablation technologies, catheter systems, and related materials/assembly processes.
• Strong problem‑solving skills, excellent written and verbal communication, and the ability to lead cross‑functional project teams.
• Familiarity with Quality Management Systems (QMS), ISO 13485, and medical device regulatory requirements; experience with regulatory submission writing is highly desirable.

Benefits

• $130K - $150K base salary
• 10% Bonus
• Stock Options / Equity
• 401K with match
• Health, Dental, Vision, LTD, and HSA
• 3 weeks PTO + 11 holidays