Senior Biomedical Engineer

Senior Biomedical Engineer

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

- For this position, you must be currently authorized to work in the United States without the need for sponsorship for a non-immigrant visa. CyberCoders will consider for Employment in the City of Los Angeles qualified Applicants with Criminal Histories in a manner consistent with the requirements of the Los Angeles Fair Chance Initiative for Hiring (Ban the Box) Ordinance.This job was first posted by CyberCoders on 09/24/2026 and applications will be accepted on an ongoing basis until the position is filled or closed.Everforth CyberCoders is proud to be an Equal Opportunity Employer

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity or expression, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, status as a crime victim, disability, protected veteran status, or any other characteristic protected by law. Our hiring process includes AI screening for keywords and minimum qualifications, and a virtual recruiter as part of the application process. A human recruiter reviews all results. Click here for details on our virtual recruiter .  Everforth CyberCoders will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable state and local law, including but not limited to the Los Angeles County Fair Chance Ordinance, the San Francisco Fair Chance Ordinance, and the California Fair Chance Act. Everforth CyberCoders is committed to working with and providing reasonable accommodation to individuals with physical and mental disabilities. Individuals needing special assistance or an accommodation while seeking employment can contact a member of our Human Resources team at Benefits@CyberCoders.com to make arrangements.

Salary

$130000 - $150000 USD per year

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