EBR Systems, Inc. · 2 months ago
Senior Quality Engineer (Electrical & Software Engineering)
Sunnyvale, CA
Full-time
Onsite
Senior Level
$127K/yr - $163K/yr
7+ years expEBR Systems, Inc. is a pioneering company in cardiac technology, known for developing the world’s first FDA approved, leadless left ventricular endocardial pacing device. The Senior Quality Engineer will lead quality assurance efforts, manage documentation for design verification, and ensure compliance with regulatory requirements while supporting production and troubleshooting issues.
BiotechnologyHealth CareMedicalMedical Device
Responsibilities
Act as the Subject Matter Expert for QA for Design Control SOPs, DHF, Standards Compliance, and Design Transfer records. Support regulatory audits of Product Development function and outputs
Review, approve, and provide guidance for Design Verification and Validation activities, product and software traceability matrix
Responsible for quality engineering review of Document Change Orders for Product Development and Software update
Perform firmware/software verification, regression, and integration testing: including testing software fixes, cybersecurity update and logging/tracking software defects
Experience with Printed Circuit Boards (PCB), electronics laboratory equipment, validation of system with rechargeable battery
Create and design appropriate test methods, protocols and accurately generate complex written reports which include establishing statistical confidence by identifying sample size and acceptable error rates. This includes testing for process validations, test method validation and data analysis
Lead CAPA generation, performing thorough root cause investigation and documenting corrective and preventative action plans. Ensure action plans are implemented in a timely manner
Evaluate significant product and/or process changes and enhancements which reduce defects, improve yields, and lower product cost. Proactively solve moderately complex problems at the product level
Assist with risk analysis activities and maintaining up to date risk management documents
Support company goals and objectives, policies and procedures, Quality System Regulation, and FDA/EU MDR regulations. Adhere to established company Quality System procedures, the Quality Policy, and work instructions
Maintain state of the art technical knowledge
Partner with the Regulatory Affairs staff to ensure technical accuracy for domestic and international regulatory filings
Other duties as assigned
Qualification
Required
BS in electrical, software Engineering, or equivalent biomedical Engineering with software engineering experience
Minimum seven (7) years of experience is preferred, with related medical device experience
Understanding of regulatory requirements for the medical device industry, specifically, IEC 60601, IEC 62304, 21 CFR 820, ISO 13485, ISO 14971, and HIPPA
Proficiency with PC-based office computers, including familiarity with Microsoft Office suite required
Strong foundation in education, skills in electrical and software engineering
Expert in tools and processes for root cause analysis
Ability to work independently, using good judgment, initiative and analytical abilities, to accomplish short and long-range projects, anticipate likely needs, and recommend actions with minimal direction
Ability to work as a team member and ability to be very flexible, adaptable, and to work under pressure
Self-motivated and self-directed; conscientious approach to work assignments; enjoys the challenges of multitasking and working at a fast pace while staying flexible to shift tasks frequently
Ability to clearly write engineering justifications and analyses connecting product performance with compliance requirements
Travel required up to 10% of the time, including weekend and overnight travel
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
Preferred
Minimum seven (7) years of experience is preferred, with related medical device experience
Proficiency with statistical software, such as MiniTab, preferred
Benefits
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!
Company
EBR Systems, Inc.
EBR Systems, Inc.
51-200 employees
H1B Sponsorship
EBR Systems, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (1)
2023 (1)
2022 (1)
2021 (2)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$248.68MKey Investors
Thomas FogartyDelphi Ventures
2025-06-18Post Ipo Equity· $13M
2025-05-22Post Ipo Equity· $35.83M
2021-07-29IPO
Leadership Team
Allan Will
Executive Chair of the Board of Directors (previously CEO)
John McCutcheon
President and CEO
Recent News
Morningstar.com
2025-10-14
Company data provided by crunchbase