Biomedical Engineer

Biomedical Engineer - Medical Device Development

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. We do not sponsor for this position.