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Biomedical Engineer

Biomedical Engineer - Medical Device Development (Catheter Systems)

Location: Hybrid (Tue-Thurs) in Oakland
Position Overview
We are seeking a Biomedical Engineer to support design, development, and regulatory readiness for novel medical devices, with a focus on thermal ablation catheter systems. This role will drive R&D activities from concept through prototyping, verification and validation, and support GLP preclinical studies and early clinical trials. The successful candidate will balance hands-on engineering (CAD/prototyping/testing) with documentation and regulatory coordination to ensure safe, compliant, and manufacturable products.
Key Responsibilities

• Lead design and development of catheter-based medical devices, including RF, microwave, cryo, and thermal ablation catheter systems.
• Create and iterate CAD models and detailed part drawings using SolidWorks to support prototyping and transition to manufacturing.
• Build and manage rapid prototypes and functional assemblies; plan and execute engineering tests, bench evaluations, and design verification studies.
• Develop and maintain Design History File (DHF) documentation, design control records, and technical documentation required for regulatory submissions.
• Support preparation of regulatory submission materials and liaise with regulatory/quality teams to ensure compliance with FDA requirements and international standards.
• Implement and maintain risk management activities in accordance with ISO 14971, including creation and update of risk analyses and mitigation plans.
• Coordinate GLP preclinical studies and provide engineering support for early clinical trials, including test protocols, data collection, and troubleshooting.
• Work with suppliers and contract manufacturers to qualify components, manage change control, and ensure supply chain robustness.
• Collaborate cross-functionally with electrical, mechanical, clinical, and quality teams to resolve technical issues and drive product development milestones.
• Support sterilization and biocompatibility strategy (ISO 10993) and sterilization validation processes (e.g., ISO 11135) as they relate to device materials and manufacturing.

Qualifications

• Bachelors or Masters degree in Biomedical Engineering, Mechanical Engineering, or related field.
• 3+ years of experience in medical device development, preferably with catheter systems or interventional devices; experience with RF/microwave/cryo/thermal ablation technologies is strongly preferred.
• Proven proficiency in CAD (SolidWorks) and hands-on prototyping and engineering testing.
• Direct experience preparing and maintaining DHF documentation, design controls, and technical files for regulatory submissions.
• Solid working knowledge of FDA 21 CFR 820 (QSR), ISO 13485, and ISO 14971 requirements.
• Experience supporting GLP preclinical studies and early clinical trials, including familiarity with study protocols and data management expectations.
• Familiarity with biocompatibility testing requirements (ISO 10993) and sterilization standards and methods (ISO 11135 preferred).
• Experience with supplier management, component qualification, and design transfer to manufacturing.
• Strong analytical and problem-solving skills, excellent written and verbal communication, and ability to work effectively in multidisciplinary teams.
• Preferred: prior experience at a medical device company, familiarity with Quality Assurance/Regulatory Affairs interactions, and a track record of successful regulatory submissions to the FDA.

Benefits

• Performance Bonus
• 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 06/17/2026 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

$100000 - $130000 USD per year