Senior Biomedical Engineer

Job Title: Sr Biomedical Engineer with Electrical and firmware background

Location: 101 W Dickman St, Suite 300, Baltimore, MD 21230
Employment Type: Full-time

About Novel Microdevices:

Novel Microdevices is redefining point-of-care diagnostics with cutting-edge diagnostics products designed for rapid, reliable, and actionable medical insights. Our team is building next-generation diagnostic platforms using embedded systems, real-time image processing, and cloud-integrated data solutions to empower healthcare professionals worldwide.

Job Summary:

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.

Key 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
  • Author and execute Verification & Validation (V&V) plans, protocols, and reports
  • 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
  • Define clear acceptance criteria aligned with product requirements and intended use
  • Develop detailed test protocols, test cases, and verification procedures with strong traceability to requirements
  • Conduct experiments, ensuring accurate data collection, logging, and traceability in compliance with quality standards
  • Analyze test data and document results in technical reports, including conclusions and recommendations
  • Collaborate with cross-functional teams to review test strategies and results

• Calibration, Manufacturing Transfer & Process Development
  • Develop and validate calibration procedures for instruments and subsystems
  • Ensure calibration processes are robust, repeatable, and transferable to manufacturing technicians
  • Define and document acceptance/rejection criteria for instruments and subassemblies
  • Provide training and documentation to support manufacturing and quality teams
  • Support design transfer activities, ensuring smooth transition from development to production

Required Qualifications:

• Background in biomedical, systems, or electrical/mechanical engineering which translates into cross functional ability to work with electronics/firmware and able to understand biological systems to run assays on a microfluidic device and interpret the data

• 3+ years of relevant industry experience working with Medical Devices (IVD preferred)
• Familiarity with FDA design controls, ISO 13485, and risk management standards
• Strong systems thinking and communication skills to work across hardware, software, and biological interfaces

Compensation and Benefits:

• Annual salary: 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.
• Access to standard benefits package including healthcare and other company-offered plans.

Additional Information:

• Employment is at-will.
• Role is in-person and due to the nature of the work, it cannot be supported adequately from a remote location
• Must be authorized to work in the United States.