Biomedical Engineer

Senior Biomedical Engineer | Oakland, CA

Location: Oakland, CA (Onsite)

Industry: Medical Devices / Biomedical Engineering / Catheter Development

Experience: 7-10+ Years

Client is seeking a Senior Biomedical Engineer to lead the development of catheter-based medical devices from concept through commercialization.

Key Responsibilities:

• Lead catheter-based device development, design transfer, and manufacturing handoff.
• Translate clinical and user needs into product requirements and V&V strategies.
• Design and develop catheter components using SolidWorks/CAD .
• Perform hands-on prototyping, troubleshooting, and product testing.
• Author and maintain DHF , Design Controls, Risk Management ( ISO 14971 ), and V&V documentation.
• Support FDA submissions including 510(k), PMA, IDE, and related technical documentation.
• Manage suppliers, contract manufacturers, and process improvements.
• Support pilot production lines, design transfer, and IQ/OQ/PQ activities.
• Collaborate with Quality, Regulatory, Clinical, and Manufacturing teams.

Required Qualifications:

• Bachelor's or Master's degree in Biomedical, Mechanical, Materials, or related Engineering field.
• 7+ years of medical device development experience.
• Strong experience with catheter-based devices and Class II/III medical products.
• Hands-on experience with SolidWorks, prototyping, bonding, tipping, reflow, and assembly .
• Knowledge of FDA 21 CFR 820, ISO 13485, ISO 14971 , Design Controls, and Design Transfer.
• Experience supporting manufacturing scale-up and supplier management.

Preferred Qualifications:

• Energy-based or ablation catheter systems (RF, Microwave, Cryo).
• FDA submissions (510(k), PMA, IDE, De Novo).
• Biocompatibility, sterilization, and shelf-life testing.
• GLP Preclinical Studies, Clinical Trials, and IEC standards.
• DOE, Gauge R&R, Cpk, and process characterization experience.