Role Description
The Clinical Specialist I at CVRx is responsible for providing expert support and education related to the precise titration and functionality checks of our company's medical device, primarily focusing on implantable devices requiring post-procedure adjustments and rigorous performance verification. This role involves direct interaction with healthcare professionals and adherence to strict regulatory and quality standards as well as internal protocols.
Key Duties and Responsibilities
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Device Titration and Optimization
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Provide clinical and technical support to physicians, nurses, and other allied healthcare professionals on the proper techniques for device titration and programming to optimize patient outcomes.
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Independently supports device titrations in real-time (either on-site or remotely) to ensure devices are correctly calibrated according to the physician's prescription and patient needs.
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Educate clinical staff on advanced programming features, troubleshooting, and best practices for chronic management of the device settings.
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Serve as a primary technical resource for clinical inquiries regarding device operation, troubleshooting, and complex patient cases.
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Device Functionality Checks and Quality Assurance
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Independently perform and document thorough device checks (e.g., integrity checks, battery status, lead/sensor impedance, therapeutic output) following implant, during follow-up, and as required by protocols.
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Identify, document and report any potential device anomalies or performance deviations to the appropriate internal teams (e.g., R&D, Quality, Regulatory).
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Maintain meticulous records of all titration, programming, and check procedures in compliance with company policy and regulatory requirements (e.g., FDA, ISO).
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Collaboration and Compliance
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Collaborate closely with Sales, Research & Development, Clinical Affairs, and Quality teams to provide field feedback that can inform product improvements and clinical strategy.
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Ensure strict adherence to all relevant regulatory guidelines (e.g., HIPAA, GDPR, medical device regulations) and company Standard Operating Procedures (SOPs).
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Participate in clinical trials or post-market surveillance activities as needed, performing scheduled device checks and data collection.
Qualifications
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Bachelor's degree in a relevant scientific or technical field (e.g., Biomedical Engineering, Nursing, Cardiovascular Technology, or equivalent experience).
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Exceptional understanding of medical terminology, human anatomy, and disease states relevant to the device technology.
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Strong technical aptitude for operating proprietary device programming software and diagnostic equipment.
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Excellent written and verbal communication, presentation, and interpersonal skills.
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Detail-oriented with a strong commitment to quality and regulatory compliance.
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Self-motivated and able to work independently in a dynamic, fast-paced clinical environment.
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A strong patient-safety orientation and professional demeanor.
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Ability to travel up to 70% regionally by car; some air travel may be required infrequently.
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Reliable personal transportation able to support travel requirements.
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Valid, current ID for driving.
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Reliable high-speed internet and private office space at home to support remote work/officing.
Requirements
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An advanced degree is preferred.
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Preferred, not required, experience in implantable device programming, titration, and/or performance analysis.
Benefits
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Health & Dental Insurance options with generous Company contributions.
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Company contributions to an HSA if enrolled in a high deductible plan.
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401(k) with company match.
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Employee stock purchase plan & stock option grants.
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12 company-paid holidays per year plus generous PTO plan.
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Paid time off for new parents.
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Company-paid life insurance & disability.
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Unlimited growth opportunities.
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Training & learning opportunities.
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Flexible Schedules.