Staff R&D Engineer

Ebr Systems, Inc.; Milano; In loco; EUR 133.000 - 161.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical insurance

401(k) matching

Paid Time Off

Employee stock options

Education assistance

Commuter benefits

Weekly company lunches

Descrizione del lavoro

EBR Systems, Inc. is seeking a Staff R&D Engineer to lead product development from concept through design transfer, combining mechanical/biomedical engineering with rigorous project execution.

The role requires driving plans, managing critical paths, mitigating risks, and ensuring compliance with FDA/ISO design controls. It offers growth in a fast-moving startup culture with competitive compensation and comprehensive benefits.

Competenze

• BS degree in mechanical, biomedical, or related engineering.
• 8+ years of progressively complex engineering and product development experience.
• Knowledge of medical device regulations and standards (FDA, ISO 13485, ISO 14971).
• Strong project management skills and ability to lead cross-functional teams.

Mansioni

• 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.
• Ensure complete traceability from design inputs through design outputs and verification and validation.

Conoscenze

Project management

Medical devices

Design controls

Risk management

V&V

SolidWorks

Regulatory knowledge

Cross-functional teams

Formazione

BS degree in mechanical, biomedical, or related engineering

Strumenti

SolidWorks

Microsoft Office

Descrizione del lavoro

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 and strong problem-solving abilities
• SolidWorks proficiency preferred
• Full product life cycle experience preferred
• Strong verbal and written communication skills; ability to concisely explain technical concepts to technical and non-technical stakeholders
• Proficiency with Microsoft Office and the ability to create analytical spreadsheets
• Ability to perform computerized project scheduling

Physical Requirements

• Required to stand, walk and sit; talk or hear; use hands to finger, handle or feel objects or controls; reach with hands and arms.
• Required to stoop, kneel, bend, crouch and lift up to 20 pounds.
• Specific vision abilities required by this job include close vision, distance vision, depth perception, color vision and the ability to adjust focus.
• Subject to extended periods of sitting and/or standing, vision to monitor, and moderate noise levels.

Salary Range $152,600 - 185,000*

*Base pay is one part of your total compensation. The salary offered will depend on several factors, including, but not limited to your experience, knowledge, skills, location, internal equity, and market alignment. Addition compensation may include bonuses and equity, along with a comprehensive benefits package.

EBR Systems, Inc. does not accept unsolicited resumes from headhunters, recruitment agencies, or fee-based recruitment services. Please refrain from solicitations at this time.

About the Company

What if your work doesn’t just support innovation—what if it changes lives?

We don’t just create game-changing medical devices—we grow people. Patients come first in everything we do. You will be empowered to solve real problems and to do meaningful work that truly makes a difference.

If you are driven by purpose, excited by challenge, and ready to shape the future of cardiac technology, we want to hear from you. Visit us at https://www.ebrsystemsinc.com/ to learn more—and join us in our work Empowering Physicians, Powering Hearts.

EBR Systems, Inc. offers a great place to work as well as generous benefits and growth opportunities:

• Medical, dental, and vision insurance provided at no cost for employee-only coverage
• 401(k) matching plan
• Paid Time Off – starting at 3 weeks per year
• Competitive salary with opportunities for career growth
• Employee stock options
• Life & AD&D and long-term disability insurance
• Education assistance
• Voluntary commuter benefits and pet insurance
• Weekly company lunches and occasional happy hour events
• Meaningful work and much more!

Equal Opportunity Employer Veterans/Disabled