Staff R&D Engineer, Medical Devices — Lead & Deliver

EBR Systems, Inc.; Santa Clara (CA); Sur place; USD 153 000 - 185 000; Plein temps

Avantages offerts par ce poste

Medical insurance

401(k) matching

Paid time off

Stock options

Education assistance

Commuter benefits

Résumé du poste

EBR Systems, Inc. seeks a Staff R&D Engineer to lead and manage product development projects from concept through design transfer, applying rigorous design controls and cross-functional collaboration.

You will drive risk management, traceability, and documentation, mentor engineers, and help deliver cost-effective solutions that improve device performance and enable scalable manufacturing.

Qualifications

• BS degree in mechanical, biomedical, or related engineering.
• 8+ years of progressively complex engineering and product development experience preferred.

Responsabilités

• Lead and manage product development projects from concept through design transfer in accordance with design controls.
• Develop and manage project plans, timelines, milestones, deliverables, dependencies, and critical path to drive timely execution.
• Identify project risks and barriers, develop mitigation strategies, and drive resolution across engineering and cross-functional teams.
• Prioritize engineering activities and resources to achieve project objectives while balancing schedule, technical rigor, quality, safety, and compliance.
• Apply strong mechanical/biomedical engineering and product development expertise to define problems, evaluate options and tradeoffs, make decisions, and resolve technical challenges.
• Drive innovative, cost-effective product solutions that optimize device performance and support scalable manufacturing.
• Lead product development, risk management, requirements development, design reviews, and design documentation in accordance with standards, regulations, and company procedures.
• Ensure complete and accurate traceability from design inputs through design outputs and verification and validation.
• Lead concept generation and contribute to intellectual property, supplier and consultant management, and technical documentation.
• Communicate objectives, priorities, risks, and technical decisions effectively across all organizational levels and functions.
• Coordinate with engineering, manufacturing, clinical, quality, regulatory, sales, and marketing functions to support product development, pilot production, and launch.
• Mentor and provide technical leadership to engineers and technicians.
• Stay current with relevant competitive technologies and medical, technical, and biomedical advancements.
• Support resolution of nonconformances, corrective and preventive actions, product complaints, and safety issues.

Connaissances

Project management

Regulatory knowledge

Communication skills

Problem-solving

Product development

Formation

BS in mechanical/biomedical engineering

Outils

SolidWorks

Description du poste

EBR Systems, Inc. seeks a Staff R&D Engineer to lead and manage product development projects from concept through design transfer, applying rigorous design controls and cross-functional collaboration.

You will drive risk management, traceability, and documentation, mentor engineers, and help deliver cost-effective solutions that improve device performance and enable scalable manufacturing.