Senior Biomedical Engineer

Senior Biomedical Engineer

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 hybrid role in Emeryville (onsite Tue-Thurs). Key responsibilities include:

• 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 include:

• 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 include:

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

For this position you must be currently authorized to work in the United States. We do not sponsor for this position.