Staff R&D Engineer

Description
About EBR Systems
At EBR Systems, we're not imagining the future of cardiac care. We're building it. We are the team behind the world's first FDA-approved leadless left ventricular endocardial pacing device for heart failure. It's a breakthrough that's redefining what's possible, and it's just the beginning.
Based in Silicon Valley, we're advancing the WiSE System, a first-of-its-kind device in cardiac rhythm management. Your work here has a direct line to patients whose lives depend on what we build. We hire people who want to solve hard problems and who care about getting it right.
We invest in our people as much as our technology. Expect a collaborative, transparent culture, real career growth in a fast-moving startup, competitive compensation, equity, comprehensive benefits, and generous PTO.
If you want your work to matter, EBR is where you belong.
The Opportunity: The Staff R&D Engineer leads and manages product development projects from concept through design transfer, combining strong mechanical/biomedical engineering expertise with disciplined project execution. This role translates development objectives into executable project plans, manages critical path, drives timely execution on aggressive timelines, communicates effectively across all levels and functions, proactively resolves barriers, and ensures compliance with regulations, standards, and design controls. The role also leads design control activities, including design and development documentation, risk management, design inputs, traceability, V&V, and design reviews. The Staff R&D Engineer applies strong product design and development expertise to optimize device performance, develop cost-effective solutions, and resolve technical challenges. ESSENTIAL AND OTHER DUTIES AND RESPONSIBILITIES:
Essential Duties
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.
Challenge technical assumptions and proposed solutions to improve product and project outcomes.
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.
Other Duties and Responsibilities
Perform other duties as assigned
SUPERVISORY RESPONSIBILITIES:
No direct reports. Provides technical leadership and mentorship to engineers and technicians.
QUALIFICATIONS:
Education and Required Experience:
BS degree or equivalent in mechanical, biomedical, or related engineering discipline
8+ years of progressively complex engineering and product development experience preferred
Knowledge, Skills, and Abilities:
Strong project management skills
Product development experience in the medical device industry, including product design, prototyping, design verification & validation testing
Knowledge of medical device regulations and standards preferred, including FDA, ISO 13485, and ISO 14971
Detail-oriented