Novelmicrodevices
Senior Biomedical Engineer
Baltimore, Maryland · Senior · Full-time
No sponsorship$100k-$140kDetected 31 days ago
Embedded SystemsSystems EngineeringMechanical DesignFDA RegulatoryMedical DevicesExperimental DesignCommunication
About the role
- We are looking for a highly motivated and detail-oriented Engineer to lead testing and verification efforts for the Novel Dx device.
- In this role, you will operate at the interface of Systems Engineering and assay performance, developing calibration protocols for manufacturing and driving Clinical Verification and Validation (V&V) activities. You will design and execute test strategies to ensure the device consistently meets performance and regulatory requirements.
- In this role, you will operate at the interface of Systems Engineering and assay performance, developing calibration protocols for manufacturing and driving Clinical Verification and Validation (V&V) activities.
Responsibilities
- Design Control & Regulatory Documentation
- Maintain and organize Design History Files (DHF) in compliance with FDA 21 CFR 820 and applicable standards for 510(k) submissions
- Develop and manage a comprehensive requirements traceability matrix (RTM) spanning user needs, product requirements, and subsystem specifications
- Perform and document risk management activities including hazard analysis, FMEA, and risk mitigation strategies (per ISO 14971)
- Lead and facilitate cross-functional design reviews, ensuring design control compliance
- Support Corrective and Preventive Actions (CAPA) investigations and documentation arising from V&V activities
- System Verification, Testing & Experimental Design
- Design and execute experimental strategies to evaluate performance of engineering and biological subsystems
- Develop detailed test protocols, test cases, and verification procedures with strong traceability to requirements
- Analyze test data and document results in technical reports, including conclusions and recommendations
Requirements
- Must be authorized to work in the United States.
Compensation
- Based on experience, it will be between $100,000 to $140,000 (subject to standard withholdings and deductions).
- Bi-weekly pay schedule.
- Eligible for the Company's Employee Stock Option Incentive Plan.
- Annual salary: Based on experience, it will be between $100,000 to $140,000 (subject to standard withholdings and deductions).
Benefits
- Eligible for the Company's Employee Stock Option Incentive Plan.
- Access to standard benefits package including healthcare and other company-offered plans.
Visa & Work Authorization
- Must be authorized to work in the United States.
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