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 #J-18808-Ljbffr CyberCoders, Inc.