What is more important than our health and well-being? Add more meaning to your life and our patients’ and join EBR Systems Inc. where our mission is to “Transform the lives of patients suffering from heart failure by developing technology that enables physicians to deliver optimal cardiac pacing Systems.” We need a talented R&D Engineer that is passionate about cardiac electrophysiology that will support us on our journey to improve patient lives, that can manage hardware (HW) and software (SW) projects. 

As a Sr. R&D Engineer, this position will oversee software and hardware projects, lead technical discussions, and develop project timelines. You will work with various teams to define and manage requirements, ensuring thorough validation and testing. Additionally, you will support investigations, maintain professional relationships, and stay informed about relevant technologies and practices. 

Essential Duties and Responsibilities 

• Manage implantable software and hardware projects. 
• Drive technical projects: Lead technical meetings, design reviews, and phase reviews. 
• Create project schedules and plans: Manage project plans and the design history file (DHF). 
• Collaborate across teams: Work with Quality, Regulatory, pre-clinical, Clinical, Marketing, and Engineering. 
• Draft requirements: Define customer and design requirements, and methods for testing. 
• Develop and trace requirements: Ensure design verification, manage requirements tracing, and conduct DHF gap analysis. 
• Draft protocols and reports: Perform software and hardware V&V testing, tool validation, usability testing, and pre-clinical validation. 
• Write manufacturing instructions: Develop test requirements, assembly and test instructions. 
• Lead cross-functional collaborations: Focus on design and process risk management. 
• Create development plans: Draft software and hardware development plans, design descriptions, and architecture. 

Other Duties and Responsibilities 

• Understand electrophysiology and solutions for cardiac pacing and heart failure. 
• Learn about cardiac electrophysiology and clinical instruments used in the lab. 
• Support complaints investigation, and corrective and preventative actions.
• Collaborate with Quality Assurance and Regulatory Affairs for accurate regulatory filings. 
• Maintain a professional image with physicians, consultants, suppliers, and co-workers. 
• Perform other duties as assigned. 

Education, Experience, and Knowledge: 

• BS in Biomedical Engineering, Software Engineering, or Electrical Engineering (MS preferred). 
• 7-10 years in the medical device industry, preferably with cardiac active implantable firmware and software design. 
• 5 years as a systems engineer leading hardware and software product development from inception to launch. 
• Must have a strong understanding of systems engineering principles, concepts, scientific, technological and management methods. 
• Writing HW/SW technical protocols, reports, and performing V&V testing. 
• Creating and managing requirements, trace matrices, and using requirements management tools. 
• Leading project meetings, design reviews, phase reviews, and creating project schedules and meeting minutes. 
• Familiarity with FDA 21 CFR 820, IEC-60601-1, IEC-62304, and IEC-62366-1 standards. 
• Preferred experience with ISO-14708 and ISO-14117 standards. 
• Interfacing with and managing standards test labs. 
• Drafting software development plans, design descriptions, and software architecture. 
• Knowledge of design control processes per ISO-13485 and risk management per ISO-14971.  
• Excellent communication and writing skills for collaboration. 
• Strong time management and organizational skills. 
• Proficiency with Microsoft Office, MS Project, MS Visio, Python scripting, MiniTab preferred. 
• Self-motivated, conscientious, and adaptable to multitasking in a fast-paced environment. 
• Data-driven with strong analytical and problem-solving abilities.  
• Proclivity to tinker and be hands-on, with a keen interest in exploring and solving technical challenges. 
• Ability to sit or stand for up to 8 hours per day.
• Ability to work on a computer for up to 8 hours per day.
• Manual dexterity / fine motor skills, if working with precision equipment.
• Ability to lift up to 20 lbs.
• Ability to distinguish colors if needed to perform the job. 

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.  

Salary Range

$122,500 - $157,500

Base pay is one part of your total compensation. The final starting salary offer to the successful candidate will be determined by evaluating several factors, such as education, 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.

About EBR Systems

Silicon Valley's EBR Systems is revolutionizing cardiac rhythm disease treatment with its WiSE™ CRT System technology, eliminating the need for pacing leads. Our dedicated team is committed to providing safe, cost-effective wireless cardiac stimulation therapies for millions of patients.

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

• Medical, dental, and vision insurance
• 401K
• PTO – starting at 3 weeks per year
• Competitive salary with opportunities for career growth
• Employee stock options
• Life insurance
• Weekly company lunches and occasional happy hour events