Jobs at EBR Systems, Inc.

Leads medical device product development from concept through design transfer, managing project plans, critical paths, technical risks, design controls, requirements, risk management, traceability, verification and validation, and design reviews. Applies mechanical or biomedical engineering expertise to optimize device performance, cost, manufacturability, and compliance. Coordinates cross-functional teams, supports pilot production and launch, resolves quality issues, manages suppliers and consultants, and mentors engineers and technicians.

Processes customer invoices and vendor bills; monitors accounts receivable, supports collections, resolves vendor invoice issues, and performs accounts payable activities. Assists with month-, quarter-, and year-end close, reconciliations, accruals, expense allocations, variance analysis, and audit support. The role is fully in-office five days per week in Santa Clara, California, with no supervisory responsibilities.

Leads regulatory strategy and submissions for Class III medical devices across US and international markets. Evaluates product and manufacturing changes, reviews technical, labeling, risk, promotional, and quality documents, supports audits, engages regulatory bodies, maintains compliance knowledge, and improves regulatory processes. The role requires cross-functional collaboration, project timeline management, and regulatory guidance for new and existing cardiac device products.

Provide clinical and technical subject-matter expertise for post-market surveillance and complaint investigations of implantable cardiac devices. Assess device performance, determine regulatory reportability, support root cause analysis, identify safety signals, ensure compliance with global regulations, and drive continuous improvement in complaint handling and PMS processes.