Senior Lead Field Clinical Engineer
EBR Systems, Inc.
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $117,700 - $151,300 per year
Job Level
About the role
- Serve as a clinical and technical subject matter expert within Quality Assurance and provides advanced clinical expertise to assess device performance concerns, determine regulatory reportability, identify root causes, and support risk management activities.
- Play a key role in ensuring regulatory compliance, identifying safety signals, and supporting product quality and patient safety.
- Collaborate cross-functionally with Quality, Regulatory Affairs, R&D, Manufacturing, and Clinical teams to evaluate complaints, interpret clinical and device data, and ensure accurate, compliant complaint handling in accordance with FDA, EU MDR, and other global regulatory requirements.
- Partner closely with Field Clinical and Technical teams to ensure timely reporting of device-related issues and collection of complete, high-quality information to support thorough complaint investigation and evaluation.
- Act as senior clinical and technical SME for complaint investigations involving implantable medical devices including assessment of device performance and patient outcomes.
- Support Quality Leadership in identifying emerging product performance trends, reliability concerns, and potential risk signals through complaint trending and data analysis.
- Perform global regulatory reportability assessments in accordance with applicable regulations, including FDA Medical Device Reporting (21 CFR 803), EU MDR Vigilance Reporting, TGA, PMDA, MHRA, and other international regulatory requirements.
- Provide clinical and technical input to support regulatory submissions, responses to Competent Authority inquiries, and vigilance reporting activities.
- Participate in cross-functional reviews of complaint trends, product performance, reliability, and patient safety.
- Support internal audits, external audits, and regulatory inspections related to complaint handling, vigilance reporting, and post-market surveillance activities.
- Drive continuous improvement of post-market surveillance (PMS) and complaint handling processes.
Requirements
- Bachelor’s degree in nursing or medical field required; active Registered Nurse (RN) or medical license required.
- Clinical nursing experience in cardiology, electrophysiology, heart failure, or cardiac rhythm management strongly preferred.
- Extensive hands-on experience with Cardiac Rhythm Management (CRM) devices required, including implantable pacemakers, CRT systems, ICDs, leadless pacemakers, and associated programmer systems, with demonstrated understanding of device function, programming, and clinical troubleshooting.
- Minimum of 5–7 years of experience in Post-Market Surveillance, Complaint Handling, Clinical Quality, or Medical Device Quality within the medical device industry, preferably supporting implantable cardiac devices or other Active Implantable Medical Devices (AIMDs).
- Demonstrated ability to apply clinical knowledge to evaluate device-related complaints, assess patient outcomes, and distinguish between device-related, procedural, and patient-specific contributing factors.
- Strong working knowledge of global medical device regulations and standards, including FDA 21 CFR Part 803 (Medical Device Reporting) and Part 820 (Quality System Regulation), EU MDR 2017/745 Vigilance requirements, MEDDEV 2.12-1, ISO 13485, ISO 14971, and international regulatory frameworks including TGA, PMDA, and MHRA.
- Deep understanding of cardiology and cardiac rhythm management therapies.
- Advanced proficiency in Microsoft Excel (pivot tables, macros, formulas, charting) and PowerPoint for metric and trend visualization.
- Familiarity with Microsoft Planner for project tracking and task management.
- Excellent written communication skills with the ability to simplify complex technical information.
- Analytical mindset with exceptional attention to accuracy and data integrity.
- Demonstrated ability to work cross-functionally and manage multiple priorities in a fast-paced, regulated environment.
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!
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical expertiseregulatory compliancecomplaint handlingPost-Market SurveillanceCardiac Rhythm Management devicesdevice performance assessmentdata analysisclinical troubleshootingrisk managementvigilance reporting
Soft Skills
written communicationanalytical mindsetattention to accuracycross-functional collaborationability to manage multiple priorities
Certifications
Bachelor’s degree in nursing or medical fieldRegistered Nurse (RN) license