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
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