R&D Engineer II

The R&D Engineer II will develop products, requirements, risk documentation, test protocols, test methods, execute testing, generate reports, and perform activities in support of EBR's strategic plan. The ideal candidate is a quality-focused self-starter with high attention to detail who thrives in a small, fast-paced environment. They have strong communication skills, sense of responsibility, and drive for continuous improvement and professional growth. We seek candidates who are passionate about improving healthcare and motivated to do the hard and exciting work required to bring ground-breaking technology to market.

Essential Duties and Responsibilities

• Design and develop new products as well as product changes and enhancements which are consistent with a zero-defect level and low product cost. Solve problems at the product level. Practice design control from concept through production.
• Develop requirements based on clinical and engineering inputs, applicable standards, and regulatory authority guidance documents.
• Conduct risk analyses, provide solutions that mitigate identified risks, and generate risk management documents.
• Establish and maintain traceability between user needs, design inputs, requirements, risks, and design outputs.
• Perform design verification and validation processes. Develop test methods, design fixtures, generate test protocols, conduct regression analyses, execute testing, and author reports.
• Analyze test results utilizing design of experiments (DOE) and statistical methodology.
• Execute product development activities including bench testing, prototyping, fabrication, and troubleshooting.
• Develop and maintain design history files and related deliverables. Initiate document change orders (DCOs) in the Quality Management System (QMS).
• Communicate effectively with technical and non-technical cross-functional teams and stakeholders.
• Collaborate with the manager to establish priorities and execute plans and tasks in an aggressive manner consistent with corporate objectives.
• Manage and organize data logically to identify problems and propose solutions.
• Procure and oversee outside suppliers and services as required.
• Support resolution of product complaints, corrective and preventive actions (CAPAs), non-conformances, safety concerns, and performance issues. Determine root causes, develop possible solutions, and implement corrections.
• Support company goals and objectives, policies and procedures. Comply with good manufacturing practices, standards, and regulations.

Other Duties and Responsibilities

• Support existing product line as needed.
• Other duties as assigned.

Education and Required Experience

• BS degree or equivalent in mechanical, electrical, biomedical, or related engineering discipline and at least 2 years of experience.
• Can be an equivalent combination of education and professional experience.

Knowledge, Skills, and Abilities

• Product development experience in the medical device industry, including product design, prototyping, component manufacturing processes, and design verification and validation testing.
• Knowledge of medical device regulations and standards is preferred, including FDA 21 CFR 820, ISO 13485, and ISO 14971.
• Experience with Application Lifecycle Management (ALM) tools is preferred (e.g., JAMA, Helix).
• Strong verbal and written communication skills; ability to generate clear and concise documentation and explain complex concepts at different technical levels.
• Detail-oriented and quality-focused with strong problem-solving abilities.
• Flexible and quick to adapt to changes in a small fast-paced environment.
• Self-motivated with a growth mindset; conscientious approach to work assignments.
• SolidWorks proficiency preferred.
• Proficiency with Microsoft Office and creating analytical spreadsheets.

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.

Disclaimer: EBR Systems Inc. will never ask for personal identifying information (such as Social Security Number, bank account details, or credit card information) during the application process. All communication from EBR Systems Inc. regarding job opportunities will be conducted through official company channels.

EBR Systems, Inc. is an Equal Opportunity Employer committed to a diverse, inclusive, and equitable workplace.

Salary Range

$126,700 - $163,000*

*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.The final starting salary offer to the successful candidate will be determined by evaluating several factors, but not limited to experience, knowledge, skills, internal equity, and alignment with market data.

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

Company Overview

Silicon Valley-based EBR Systems is dedicated to superior treatment of cardiac rhythm disease by providing more physiologically effective stimulation through wireless cardiac pacing. The company's patented proprietary Wireless Stimulation Endocardially (WiSE) technology was developed to eliminate the need for cardiac pacing leads, historically the major source of complications and reliability issues in cardiac rhythm disease management.

We are a team of dedicated individuals, driven to deliver superior treatment of millions of patients suffering from cardiac rhythm diseases by developing safe, clinically superior, cost-effective, and reliable therapies using wireless cardiac stimulation. As a fast-paced company, every team member at EBR makes a big contribution towards our mission. We seek candidates who are passionate about improving #healthcare and motivated to do the hard and exciting work required to bring ground-breaking technology to market.

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

• Medical, dental, and vision insurance
• 401K Matching Plan
• PTO - starting at 3 weeks per year
• Competitive salary with opportunities for career growth
• Employee stock options
• 401(k) Bonus Program
• Life and AD&D Insurance
• Weekly company lunches and occasional happy hour events
• Meaningful work!