Staff R&D Engineer — Medical Device Innovation Leader

EBR Systems, Inc.; Santa Clara (CA); On-site; USD 153,000 - 185,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) matching

Paid Time Off

Employee stock options

Education assistance

Commuter benefits

Weekly company lunches

Job summary

EBR Systems, Inc. is seeking a Staff R&D Engineer to lead and manage product development from concept through design transfer.

You will apply mechanical/biomedical engineering expertise, drive timelines, manage risks, and ensure compliance with design controls and regulatory standards. The role involves cross-functional collaboration with engineering, manufacturing, clinical, quality, regulatory, sales, and marketing to support pilot production and launch.

Qualifications

• BS degree in mechanical/biomedical engineering or related field.
• 8+ years of progressively complex engineering and product development experience preferred.
• Knowledge of FDA/ISO 13485/14971 medical device regulations is a plus.

Responsibilities

• Lead and manage product development projects from concept through design transfer.
• Develop and manage project plans, timelines, milestones and critical path.
• Identify risks, develop mitigation strategies, and drive resolution across teams.
• Prioritize activities balancing schedule, technical rigor, quality and compliance.
• Apply engineering expertise to define problems, evaluate options and resolve challenges.
• Lead design control activities, including risk management, traceability and V&V.

Skills

Project management

Medical device dev

Regulatory knowledge

Detail oriented

SolidWorks

Product lifecycle

Communication

MS Office

Education

BS degree in mechanical/biomedical engineering

8+ years engineering experience

Tools

SolidWorks

Job description

EBR Systems, Inc. is seeking a Staff R&D Engineer to lead and manage product development from concept through design transfer.

You will apply mechanical/biomedical engineering expertise, drive timelines, manage risks, and ensure compliance with design controls and regulatory standards. The role involves cross-functional collaboration with engineering, manufacturing, clinical, quality, regulatory, sales, and marketing to support pilot production and launch.