Principal Software Engineer (Medical Devices)

Company: EBR Systems, Inc.
Location: Sunnyvale
Posted on: March 18, 2023

Job Description:

Description: 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 companys 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 a ground-breaking technology to market. The successful candidate is a hands-on Software Engineer who is a key contributor and project lead in the development of software and firmware for implantable and non-implantable devices and systems. Responsibilities extend from concept generation, design and development, prototyping, design verification and validation, to manufacturing transfer and field support of EBRs products. 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
• Bonus Program
• Life and AD&D Insurance
• Weekly company lunches and occasional happy hour events Requirements:
  • Must have medical device experience.
  • Takes primary responsibility for the development of software and firmware for implantable and non-implantable devices, including conceptualization, development of specifications, architectural and algorithmic design, implementation, test, verification and validation, and field deployment.
  • Leading development initiatives and project planning, including identification of goals consistent with company objectives and driving individual work and an extended team against the project schedule.
  • Continuous assessment of the potential need for outside services and suppliers. Participate in the selection of outside services.
  • Vendor management of outside services, as needed.
  • Participate and drive selection of tools, creation of policies (SOPs, WIs), and methods to facilitate structured software development, appropriate controls, and verification / validation efforts. Ensure that the established tools, policies, and methods are used and followed consistently by employees and outside resources.
  • Execute testing in lab environment towards design verification and validation, including protocol generation, testing, and report writing.
  • Ensure adherence to internal design controls as well as domestic and international standards for implantable and non-implantable product software.
  • Engage with quality, field, and operations teams on manufacturing issues, complaint, and CAPA resolutions.
  • Interact with cross functional team members (quality, operations, regulatory, marketing/field, and R&D) on a project-by-project basis in a variety of roles, including leading and supporting various initiatives.
  • Support regulatory needs for filings with agencies, both internationally and domestic, pertaining to software and system components.
  • Schedule projects and tasks, track and report progress toward pre-defined goals on a consistent basis. Education Requirements
    • BSEE, BSCS or other related field minimum, masters preferred. Qualifications
      • 12 years experience in architecture, design, and verification and validation of software for medical instrumentation systems and devices
      • Familiarity and adherence to software development process in a regulated environment, such as per IEC62304, IEC60601
      • Utilization of Microsoft development environment and tool suite, programming in C#.
      • Embedded programming in C
      • Matlab coding
      • Advanced and current knowledge of software engineering methods and practices, such as code reviews and static analysis, unit test execution, integration testing, system verification and validation.
      • Software tool validation experience.
      • Embedded SW development on MSP430 processor, or equivalent
      • Development on Microsoft platform with user facing features (UI).
      • Understanding of the FDAs Quality Systems Regulations 21 CFR Part 820 and AIMDD/EUMDR requirements for design control.
      • Working knowledge of FDA and EUMDR guidance on Cyber security with implementation experience in quality system and medical device product
      • Working knowledge of risk management processes PI207812918

Keywords: EBR Systems, Inc., Sunnyvale , Principal Software Engineer (Medical Devices), Other , Sunnyvale, California